Generic Name: tramadol (Oral route)

TRAM-a-dol

Commonly used brand name(s):

In the U.S.

• Ryzolt
• Ultram
• Ultram ER

Available Dosage Forms:

• Tablet, Extended Release
• Tablet

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Ryzolt

Tramadol is used to relieve moderate to moderately severe pain, including pain after surgery. The long-acting tablets are used for chronic ongoing pain.

Tramadol belongs to the group of medicines called opioid analgesics. It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine.

This medicine is available only with your doctor’s prescription.

Before Using Ryzolt

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tramadol in children younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tramadol in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems which may require caution and an adjustment in the dose for patients receiving tramadol.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rasagiline
• Selegiline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetophenazine
• Amitriptyline
• Amoxapine
• Bromperidol
• Carbamazepine
• Chlorpromazine
• Chlorprothixene
• Citalopram
• Clomipramine
• Clorgyline
• Clovoxamine
• Clozapine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dothiepin
• Doxepin
• Duloxetine
• Escitalopram
• Ethopropazine
• Femoxetine
• Fluoxetine
• Flupenthixol
• Fluphenazine
• Fluvoxamine
• Haloperidol
• Imipramine
• Isocarboxazid
• Ketamine
• Linezolid
• Lofepramine
• Loxapine
• Melperone
• Mesoridazine
• Methotrimeprazine
• Milnacipran
• Mirtazapine
• Moclobemide
• Molindone
• Nortriptyline
• Olanzapine
• Paroxetine
• Penfluridol
• Perphenazine
• Phenelzine
• Pimozide
• Pipotiazine
• Prochlorperazine
• Promazine
• Promethazine
• Propiomazine
• Protriptyline
• Remoxipride
• Risperidone
• Sertraline
• Sulpiride
• Tapentadol
• Thiethylperazine
• Thioridazine
• Thiothixene
• Tranylcypromine
• Trifluoperazine
• Triflupromazine
• Trimeprazine
• Trimipramine
• Venlafaxine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin
• Quinidine
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• CNS depression or
• Depression, history of or
• Drug abuse, history of or
• Head injury or
• Hormonal problems or
• Infections of the central nervous system (CNS) or
• Mental illness, history of or
• Respiratory depression (hypoventilation or slow breathing) or
• Seizures or epilepsy, history of or
• Stomach problems, severe—Use with caution. The chance of serious side effects may be increased.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of tramadol

This section provides information on the proper use of a number of products that contain tramadol. It may not be specific to Ryzolt. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you think that this medicine is not working as well after you have been taking it for a few weeks, do not increase the dose. Instead, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For chronic pain:
  • For oral dosage form (long-acting tablets):
    • Adults—100 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults and teenagers 16 years of age and older—50 to 100 milligrams (mg) every four to six hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

• For moderate to severe pain:
  • For oral dosage form (tablets):
    • Adults and teenagers 16 years of age and older—At first, 25 milligrams (mg) per day, taken every morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Ryzolt

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicine that makes you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your doctor or dentist before taking any of these medicines while you are using this medicine.

Make sure your doctor knows about all the other medicines you are using. This medicine may increase your risk for seizures. (convulsions) and may cause a serious condition called serotonin syndrome.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; swelling of your hands, face, or mouth; or chest pain while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for awhile. However, if nausea or vomiting continues, check with your doctor. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine. Taking tramadol together with medicines that are used during surgery or dental or emergency treatments may cause increased side effects.

If you think you or someone else may have taken an overdose of tramadol, get emergency help at once. Signs of an overdose include convulsions (seizures) and pinpoint pupils of the eyes.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.

Ryzolt Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

• Abdominal or stomach fullness
• abnormal or decreased touch sensation
• blisters under the skin
• bloating
• blood in the urine
• blood pressure increased
• blurred vision
• change in walking and balance
• chest pain or discomfort
• chills
• convulsions (seizures)
• darkened urine
• difficult urination
• dizziness or lightheadedness when getting up from a lying or sitting position
• fainting
• fast heartbeat
• frequent urge to urinate
• gaseous abdominal or stomach pain
• heart rate increased
• indigestion
• irregular heartbeat
• loss of memory
• numbness and tingling of the face, fingers, or toes
• numbness, tingling, pain, or weakness in the hands or feet
• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
• pain or discomfort in the arms, jaw, back, or neck
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale bluish-colored or cold hands or feet
• recurrent fever
• seeing, hearing, or feeling things that are not there
• severe cramping
• severe nausea
• severe redness, swelling, and itching of the skin
• shortness of breath
• sweats
• trembling and shaking of the hands or feet
• trouble performing routine tasks
• weak or absent pulses in the legs
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness
• decreased awareness or responsiveness
• difficulty with breathing
• lack of muscle tone
• lightheadedness
• loss of consciousness
• pinpointed pupils of the eyes
• severe sleepiness
• shortness of breath
• slow or irregular heartbeat
• unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain
• agitation
• anxiety
• constipation
• cough
• diarrhea
• discouragement
• drowsiness
• dry mouth
• feeling of warmth
• feeling sad or empty
• feeling unusually cold
• fever
• general feeling of discomfort or illness
• headache
• heartburn
• irritability
• itching of the skin
• joint pain
• loss of appetite
• loss of interest or pleasure
• loss of strength or weakness
• muscle aches and pains
• nausea
• nervousness
• redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• runny nose
• shivering
• skin rash
• sleepiness or unusual drowsiness
• sore throat
• stuffy nose
• sweating
• tiredness
• trouble concentrating
• unusual feeling of excitement
• weakness

Less common or rare

• Abnormal dreams
• appetite decreased
• back pain
• bladder pain
• blistering, crusting, irritation, itching, or reddening of the skin
• bloody or cloudy urine
• body aches or pain
• change in hearing
• clamminess
• cold flu-like symptoms
• confusion
• cough producing mucus
• cracked, dry, or scaly skin
• decreased interest in sexual intercourse
• difficult, burning, or painful urination
• difficulty with moving
• disturbance in attention
• ear congestion
• ear drainage
• earache or pain in ear
• excessive gas
• fall
• false or unusual sense of well-being
• feeling hot
• feeling jittery
• flushing or redness of the skin
• general feeling of bodily discomfort
• goosebumps
• headache, severe and throbbing
• hoarseness
• hot flashes
• inability to have or keep an erection
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• joint sprain
• joint stiffness
• joint swelling
• loss in sexual ability, desire, drive, or performance
• loss of voice
• lower back or side pain
• muscle aching or cramping
• muscle injury
• muscle pain or stiffness
• muscle spasms or twitching
• nasal congestion
• neck pain
• night sweats
• pain
• pain in the limb
• pain or tenderness around the eyes and cheekbones
• pain, swelling, or redness in the joints
• skin discoloration
• swelling
• swelling of the hands, ankles, feet, or lower legs
• tightness of the chest
• trouble in holding or releasing urine
• trouble with sleeping
• troubled breathing
• weight increased or decreased

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Gooseflesh
• high blood pressure
• increased sweating
• increased yawning
• shivering or trembling
• unusually large pupils

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Generic Name: Tramadol (TRAM-a-dol)
Brand Name: Examples include Ultram ER or Ryzolt

Ryzolt Extended-Release Tablets are used for:

Treating moderate to moderately severe chronic pain in certain patients.

Ryzolt Extended-Release Tablets are an analgesic. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Ryzolt Extended-Release Tablets if:

• you are allergic to any ingredient in Ryzolt Extended-Release Tablets
• you have had a severe allergic reaction (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to codeine or other opioids (eg, morphine)
• you are intoxicated with alcohol, other opioids or narcotics (eg, codeine, morphine), sedatives or sleeping medicines (eg, temazepam, zolpidem), or other medicines
• you have severe liver or kidney problems
• you are taking carbamazepine, nefazodone, sodium oxybate (GHB), a thioxanthene (eg, thiothixene), or another product that contains tramadol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ryzolt Extended-Release Tablets:

Some medical conditions may interact with Ryzolt Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription (especially depression medicines) or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver, kidney, or thyroid problems; a blockage in the bladder; diabetes; heart problems; high blood pressure; prostate problems; or metabolism problems
• if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system
• if you have a history of diarrhea caused by antibiotic use, recent stomach or bowel surgery, or any other stomach or bowel problems (eg, pain, inflammation, ulcers)
• if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]) or a seizure disorder (eg, epilepsy)
• if you are going through withdrawal from alcohol or other substances or if you have a history of alcohol or other substance abuse, mood or mental problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Ryzolt Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, ketoconazole), linezolid, lithium, macrolide antibiotics (eg, erythromycin), nefazodone, quinidine, selective serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), St. John’s wort, tricyclic antidepressants (eg, amitriptyline), or “triptans” (eg, sumatriptan) because serotonin syndrome may occur
• Anorexiants (eg, phentermine), buytrophenones (eg, haloperidol), certain medicines for mental or mood disorders (eg, olanzapine), cyclobenzaprine, furazolidone, loxapine, molindone, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine, selegiline), other opioid pain medicine (eg, codeine, hydrocodone), phenothiazines (eg, promethazine), sodium oxybate (GHB), thioxathenes (eg, thiothixene), or tiagabine, because the risk of side effects, including excessive drowsiness, trouble breathing, liver problems, or seizures, may be increased
• Other products containing tramadol because they may increase the risk of Ryzolt Extended-Release Tablets’s side effects
• Rifampin because it may decrease Ryzolt Extended-Release Tablets’s effectiveness
• Carbamazepine because it may decrease Ryzolt Extended-Release Tablets’s effectiveness; the risk of seizures may also be increased
• Anticoagulants (eg, warfarin) or digoxin because the risk of their side effects may be increased by Ryzolt Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ryzolt Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ryzolt Extended-Release Tablets:

Use Ryzolt Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ryzolt Extended-Release Tablets by mouth with or without food. Try to take it the same way (either with food or without food) each time you take your dose. Check with your doctor or pharmacist if you have questions about taking Ryzolt Extended-Release Tablets with food.
• Swallow Ryzolt Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Ryzolt Extended-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ryzolt Extended-Release Tablets.

Important safety information:

• Ryzolt Extended-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ryzolt Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ryzolt Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Ryzolt Extended-Release Tablets may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Tell your doctor or dentist that you take Ryzolt Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Serotonin syndrome is a possibly fatal syndrome that can be caused by Ryzolt Extended-Release Tablets. Your risk may be greater if you take Ryzolt Extended-Release Tablets with certain other medicines (eg, “triptans,” MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
• Use Ryzolt Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, weakness or tiredness, severe lightheadedness, and indigestion.
• Ryzolt Extended-Release Tablets should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Ryzolt Extended-Release Tablets has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ryzolt Extended-Release Tablets while you are pregnant. Ryzolt Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Ryzolt Extended-Release Tablets.

When used for long periods of time or at high doses, Ryzolt Extended-Release Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Ryzolt Extended-Release Tablets stops working well. Do not take more than prescribed.

Some people who use Ryzolt Extended-Release Tablets for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. If you suddenly stop taking Ryzolt Extended-Release Tablets, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Do not suddenly stop taking Ryzolt Extended-Release Tablets without talking with your doctor. If you need to stop Ryzolt Extended-Release Tablets, your doctor will lower your dose over time.

Possible side effects of Ryzolt Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; chest pain; difficult or painful urination; disorientation; fainting; hallucinations; irregular heartbeat; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or lightheadedness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include bluish skin; cold, clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; pinpoint pupils; seizures; slow or irregular heartbeat.

Proper storage of Ryzolt Extended-Release Tablets:

Store Ryzolt Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ryzolt Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Ryzolt Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Ryzolt Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ryzolt Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: propafenone (proe PAF e none)
Brand Names: Rythmol, Rythmol SR

What is Rythmol SR (propafenone)?

Propafenone is in a group of drugs called Class IC anti-arrhythmics. It affects the way your heart beats.

Propafenone is used in certain situations to prevent serious heart rhythm disorders.

Propafenone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Rythmol SR (propafenone)?

You should not use this medication if you are allergic to propafenone, or if you have untreated or uncontrolled congestive heart failure, a heart condition called “sick sinus syndrome” or “AV block” (unless you have a pacemaker), slow heartbeats or severely low blood pressure, an electrolyte imbalance, or a breathing disorder such as asthma.

Before you take propafenone, tell your doctor if you have congestive heart failure, liver or kidney disease, lupus, arthritis, myasthenia gravis, or if you have had a heart attack within the past 2 years.

You will need to receive your first few doses of propafenone in a hospital setting in case the medication causes serious side effects. Your heart rate will be constantly monitored using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Call your doctor at once if you have a serious side effect such as weak pulse, slow breathing, feeling like you might pass out, feeling short of breath, swelling, rapid weight gain, pale skin, easy bruising or bleeding, unusual weakness, confusion, unusual thoughts or behavior, or seizure.

What should I discuss with my healthcare provider before taking Rythmol SR (propafenone)?

You should not use this medication if you are allergic to propafenone, or if you have:

• untreated or uncontrolled congestive heart failure;

• a heart condition called “sick sinus syndrome” or “AV block” (unless you have a pacemaker);

• slow heartbeats or severely low blood pressure;

• an electrolyte imbalance; or

• a breathing disorder such as asthma.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take propafenone:

• congestive heart failure;

• liver disease;

• kidney disease;

• lupus;

• arthritis;

• myasthenia gravis; or

• if you have had a heart attack within the past 2 years.

FDA pregnancy category C. It is not known whether propafenone is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Propafenone may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Rythmol SR (propafenone)?

You will need to receive your first few doses of propafenone in a hospital setting in case the medication causes serious side effects. Your heart rate will be constantly monitored using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart.

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Store propafenone at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include drowsiness, slow heart rate, feeling like you might pass out, or seizure (convulsions).

What should I avoid while taking Rythmol SR (propafenone)?

Grapefruit and grapefruit juice may increase your blood levels of propafenone which could lead to unwanted side effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Rythmol SR (propafenone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• feeling short of breath, even with mild exertion;

• swelling, rapid weight gain;

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

• pale skin, easy bruising or bleeding, unusual weakness;

• confusion, unusual thoughts or behavior; or

• seizure.

Less serious side effects may include:

• dizziness;

• unusual or unpleasant taste in your mouth;

• nausea, vomiting;

• warmth, redness, or tingly feeling under your skin;

• constipation;

• headache;

• tired feeling;

• ringing in your ears;

• unusual dreams; or

• blurred vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rythmol SR (propafenone)?

Many drugs can interact with propafenone. Below is just a partial list. Tell your doctor if you are using:

• cimetidine (Tagamet),

• digoxin (digitalis, Lanoxin);

• ketoconazole (Nizoral);

• orlistat (alli, Xenical);

• quinidine (Quinaglute, Quinidex, Quin-Release);

• rifampin (Rifadin, Rifamate, Rimactane);

• a blood thinner such as warfarin (Coumadin);

• an antidepressant such as desipramine (Norpramin), fluoxetine (Prozac), imipramine (Tofranil), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor);

• HIV or AIDS medication such as ritonavir (Norvir) or saquinavir (Invirase);

• another heart rhythm medication such as amiodarone (Cordarone, Pacerone);

• medicine to treat psychiatric disorders, such as haloperidol (Haldol); or

• a beta-blocker such as atenolol (Tenormin), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others.

This list is not complete and there may be other drugs that can interact with propafenone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about propafenone.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.06. Revision Date: 06/12/2009 9:02:39 AM.

Generic Name: Propafenone (proe-pa-FEEN-none)
Brand Name: Rythmol SR

Rythmol SR Sustained-Release Capsules are used for:

Treating an irregular heartbeat and helping maintain a normal heart rhythm in patients without structural heart disease.

Rythmol SR Sustained-Release Capsules are a class 1C antiarrhythmic medicine. It works on different fibers of the heart to stabilize its action and regulate heartbeat.

Do NOT use Rythmol SR Sustained-Release Capsules if:

• you are allergic to any ingredient in Rythmol SR Sustained-Release Capsules
• you have congestive heart failure, certain shock conditions, certain types of irregular heartbeat (eg, sick sinus node syndrome, atrioventricular block) and you are not using an artificial pacemaker, slow heartbeat, very low blood pressure, abnormal electrolyte levels, or certain breathing problems (eg, chronic bronchitis or emphysema)
• you are taking another antiarrhythmic (eg, amiodarone, quinidine), droperidol, bepridil, cisapride, an HIV protease inhibitor (eg, ritonavir), a ketolide (eg, telithromycin), macrolide antibiotics (eg, erythromycin), a quinolone antibiotic (eg, ciprofloxacin), a certain type of phenothiazine (eg, thioridazine), a tricyclic antidepressant (eg, imipramine), or ziprasidone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rythmol SR Sustained-Release Capsules:

Some medical conditions may interact with Rythmol SR Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have kidney or liver problems or myasthenia gravis (muscle weakness)
• if you use an artificial pacemaker

Some MEDICINES MAY INTERACT with Rythmol SR Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifampin because the effectiveness of Rythmol SR Sustained-Release Capsules may be decreased
• Azole antifungals (eg, ketoconazole), cimetidine, HIV protease inhibitors (eg, ritonavir), selective serotonin reuptake inhibitor (SSRI) antidepressants (eg, fluoxetine), serotonin norepinephrine reuptake inhibitors (eg, duloxetine), or venlafaxine because the side effects of Rythmol SR Sustained-Release Capsules may be increased
• Antiarrhythmics (eg, amiodarone, quinidine), arsenic, bepridil, cisapride, droperidol, ketolides (eg, telithromycin), macrolide antibiotics (eg, erythromycin), phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, ciprofloxacin), serotonin receptor antagonist antiemetics (eg, dolasetron), tricyclic antidepressants (eg, imipramine), or ziprasidone because the risk of serious side effects, such as abnormal heart rhythms, may be increased
• Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), digoxin, haloperidol, or lidocaine because side effects may be increased by Rythmol SR Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rythmol SR Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rythmol SR Sustained-Release Capsules:

Use Rythmol SR Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Rythmol SR Sustained-Release Capsules may be taken with or without food.
• Swallow Rythmol SR Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
• Take each dose at the same time with respect to meals.
• Take Rythmol SR Sustained-Release Capsules regularly to receive the most benefit from it. Do not miss any doses.
• Eating grapefruit or drinking grapefruit juice may affect the amount of Rythmol SR Sustained-Release Capsules in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• If you miss a dose of Rythmol SR Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rythmol SR Sustained-Release Capsules.

Important safety information:

• Rythmol SR Sustained-Release Capsules may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Rythmol SR Sustained-Release Capsules. Using Rythmol SR Sustained-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Rythmol SR Sustained-Release Capsules may affect artificial pacemakers. Pacemakers should be monitored and programmed accordingly during therapy.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Rythmol SR Sustained-Release Capsules.
• LAB TESTS, including electrocardiographic tests, white blood cell counts, and electrolyte levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Rythmol SR Sustained-Release Capsules with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Rythmol SR Sustained-Release Capsules, discuss with your doctor the benefits and risks of using Rythmol SR Sustained-Release Capsules during pregnancy. Rythmol SR Sustained-Release Capsules are excreted in breast milk. Do not breast-feed while taking Rythmol SR Sustained-Release Capsules.

Possible side effects of Rythmol SR Sustained-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in taste; constipation; dizziness; drowsiness; gas; lightheadedness; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; chest pain; chills; excessive thirst; fast, slow, or irregular heartbeat; fever; loss of appetite; muscle weakness; prolonged diarrhea; shortness of breath; sore throat; sweating; swelling of the hands or feet; tremor; unexplained weakness; unusual bruising or bleeding; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include convulsions; decreased sexual ability; drowsiness; fainting; fatigue; irregular heartbeat; metallic taste; seizures; severe dizziness or drowsiness; slow heartbeat; weakness.

Proper storage of Rythmol SR Sustained-Release Capsules:

Store Rythmol SR Sustained-Release Capsules at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rythmol SR Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Rythmol SR Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Rythmol SR Sustained-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Rythmol SR Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: phenylephrine and pyrilamine (FEN il EFF rin and pir IL a meen)
Brand Names: Aldex D, Deconsal CT Tannate, K-Tan, Pyril Tann-12, Pyrlex PD, Ry-T-12, Ryna-12, Ryna-12S, Rynesa 12S, V-Tann, Viravan-S, Viravan-T

What is this drug?

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pyrilamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of phenylephrine and pyrilamine is used to treat runny or stuffy nose, sneezing, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Phenylephrine and pyrilamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about this drug?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine.

What should I discuss with my health care provider before taking this drug?

Do not use this medication if you are allergic to phenylephrine or pyrilamine, or to other antihistamines, decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking phenylephrine and pyrilamine, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease or high blood pressure;

• diabetes;

• a thyroid disorder;

• glaucoma;

• kidney disease;

• an enlarged prostate; or

• problems with urination.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take this drug?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking this drug?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pyrilamine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

This drug side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;

• severe dizziness, anxiety, restless feeling, or nervousness, confusion, hallucinations, unusual thoughts or behavior;

• easy bruising or bleeding, fever, chills, body aches, flu symptoms;

• urinating less than usual or not at all; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• nausea, stomach pain, constipation, mild loss of appetite;

• dry mouth;

• warmth, tingling, or redness under your skin;

• blurred vision;

• dizziness, drowsiness;

• problems with memory or concentration;

• restless or excitability (especially in children);

• sleep problems (insomnia); or

• skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this drug?

Before taking phenylephrine and pyrilamine, tell your doctor if you are also taking:

• a diuretic (water pill);

• salicylates such as aspirin, Novasal, Doan’s Extra Strength, Salflex, Tricosal, and others;

• an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

• atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

• bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);

• bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or

• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with phenylephrine and pyrilamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about phenylephrine and pyrilamine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:43:48 PM.

Generic Name: Phenylephrine/Pyrilamine (fen-il-EF-rin/peer-IL-a-meen)
Brand Name: Examples include Ryna-12 S and Rynesa 12S

Rynesa 12S Suspension is used for:

Relieving symptoms of sinus congestion, sinus pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Rynesa 12S Suspension is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use Rynesa 12S Suspension if:

• you are allergic to any ingredient in Rynesa 12S Suspension
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you take sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rynesa 12S Suspension:

Some medical conditions may interact with Rynesa 12S Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a fast, slow, or irregular heartbeat
• if you have a history of asthma, lung problems (eg, emphysema), adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, a blockage of your stomach or intestines, ulcers, a blockage of your bladder, trouble urinating, an enlarged prostate, seizures, or an overactive thyroid

Some MEDICINES MAY INTERACT with Rynesa 12S Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Rynesa 12S Suspension may be increased
• Digoxin or droxidopa because risk of irregular heartbeat or heart attack may be increased
• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Rynesa 12S Suspension
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Rynesa 12S Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rynesa 12S Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rynesa 12S Suspension:

Use Rynesa 12S Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Rynesa 12S Suspension may be taken with or without food.
• Shake well before using.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Rynesa 12S Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rynesa 12S Suspension.

Important safety information:

• Rynesa 12S Suspension may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Rynesa 12S Suspension. Using Rynesa 12S Suspension alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take diet or appetite control medicines while you are taking Rynesa 12S Suspension without checking with you doctor.
• Do NOT exceed the recommended dose or take Rynesa 12S Suspension for longer than prescribed without checking with your doctor.
• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
• Rynesa 12S Suspension may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Rynesa 12S Suspension. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• If you are scheduled for allergy skin testing, do not take Rynesa 12S Suspension for several days before the test because it may decrease your response to the skin tests.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Rynesa 12S Suspension.
• Use Rynesa 12S Suspension with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Rynesa 12S Suspension in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Rynesa 12S Suspension, discuss with your doctor the benefits and risks of using Rynesa 12S Suspension during pregnancy. It is unknown if Rynesa 12S Suspension is excreted in breast milk. Do not breast-feed while taking Rynesa 12S Suspension.

Possible side effects of Rynesa 12S Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Rynesa 12S Suspension:

Store Rynesa 12S Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rynesa 12S Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Rynesa 12S Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Rynesa 12S Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Rynesa 12S Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: chlorpheniramine and methscopolamine (klor fen EER uh meen and meth sko POL uh meen)
Brand Names: aeroHist, AlleRx DF Dose Pack, Ryneze

What is Ryneze (chlorpheniramine and methscopolamine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Methscopolamine reduces the secretions of certain organs in the body.

The combination of chlorpheniramine and methscopolamine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and methscopolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ryneze (chlorpheniramine and methscopolamine)?

Do not use chlorpheniramine and methscopolamine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and methscopolamine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or methscopolamine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated in hot weather. Chlorpheniramine and methscopolamine increases the risk of heat stroke because it causes decreased sweating and can make you more sensitive to sunlight.

Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and methscopolamine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety), or medicines that may cause restlessness (such as caffeine, stimulants, diet pills, and decongestants contained in over-the-counter cold medicines). They can add to the side effects of chlorpheniramine and methscopolamine.

What should I discuss with my healthcare provider before taking Ryneze (chlorpheniramine and methscopolamine)?

Do not use chlorpheniramine and methscopolamine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and methscopolamine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or methscopolamine, or if you have:

• severe or uncontrolled high blood pressure;

• severe coronary artery disease;

• narrow angle glaucoma;

• a stomach ulcer;

• if you are unable to urinate; or

• if you are having an asthma attack.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;
• liver disease;

• diabetes;

• glaucoma;

• heart disease, high blood pressure, or circulation problems;

• overactive thyroid;

• a seizure disorder such as epilepsy;

• asthma, emphysema or chronic bronchitis; or

• urination problems or an enlarged prostate.

If you have any of these conditions, you may not be able to use chlorpheniramine and methscopolamine, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Chlorpheniramine and methscopolamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 6 years old.

How should I take Ryneze (chlorpheniramine and methscopolamine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Take this medicine with a full glass of water. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using chlorpheniramine and methscopolamine. You may need to stop using the medication for a short time before having a medical test.

Store chlorpheniramine and methscopolamine at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a chlorpheniramine and methscopolamine overdose may include nausea, vomiting, severe drowsiness, shallow breathing, ringing in your ears, problems with balance or coordination, hallucinations (seeing things), sleep problems (insomnia), feeling restless or excited, blurred vision, tremors, flushed face, and seizure (convulsions).

What should I avoid while taking Ryneze (chlorpheniramine and methscopolamine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated in hot weather. Chlorpheniramine and methscopolamine increases the risk of heat stroke because it causes decreased sweating and can make you more sensitive to sunlight.

Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and methscopolamine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety), or medicines that may cause restlessness (such as caffeine, stimulants, diet pills, and decongestants contained in over-the-counter cold medicines). They can add to the side effects of chlorpheniramine and methscopolamine.

Ryneze (chlorpheniramine and methscopolamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using chlorpheniramine and methscopolamine and call your doctor at once if you have any of these serious side effects:

• problems with balance or coordination;

• severe drowsiness, feeling light-headed, fainting;

• extreme thirst and hot, dry skin;

• breathing problems;

• easy bruising or bleeding, unusual weakness;

• fever, chills, body aches, flu symptoms;

• fast or uneven heart beats;

• tight feeling in your chest;

• seizure (convulsions);

• hallucinations (seeing things that are not there); or

• tremors.

Continue using this medication and talk with your doctor if you have any of these less serious side effects:

• dry mouth, stomach pain, changes in appetite;

• drowsiness, dizziness, weakness, headache;

• dry eyes, blurred vision;

• painful or difficult urination;

• increased sweating;

• skin rash; or

• feeling nervous or excited (especially in children).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ryneze (chlorpheniramine and methscopolamine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• antacids;

• medicine to treat diarrhea (such as Immodium, Kaopectate, Pepto-Bismol);

• atropine (Donnatal, and others);

• belladonna;

• clidinium (Quarzan);

• dicyclomine (Bentyl);

• glycopyrrolate (Robinul);

• hyoscyamine (Anaspaz, Cystospaz, Levsin, and others);

• mepenzolate (Cantil);

• methantheline (Provocholine);

• methscopolamine (Pamine);

• propantheline (Pro-Banthine); or

• scopolamine (Transderm-Scop).

• a beta-blocker such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren);

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

• antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

If you are using any of these drugs, you may not be able to use chlorpheniramine and methscopolamine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect chlorpheniramine and methscopolamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has additional information about chlorpheniramine and methscopolamine written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:45:38 PM.

Generic Name: Chlorpheniramine/Methscopolamine (klor-fen-EER-a-meen/meth-skoe-POL-a-meen)
Brand Name: Ryneze

Ryneze 12-Hour Tablets are used for:

Relieving sneezing, runny nose, and watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Ryneze 12-Hour Tablets are an antihistamine and anticholinergic combination. It works by blocking a substance in the body that causes sneezing, runny nose, and watery eyes. It also dries the nose and chest.

Do NOT use Ryneze 12-Hour Tablets if:

• you are allergic to any ingredient in Ryneze 12-Hour Tablets
• you are taking sodium oxybate (GHB) or a monamine oxidase inhibitor (MAOI) (eg, phenelzine)
• you have severe heart blood vessel disease, severe high blood pressure, narrow-angle glaucoma, severe bleeding, severe irritation or other serious problems with the esophagus (eg, esophageal achalasia), peptic ulcer, a blockage of the stomach or bowel, bowel motility problems, severe bowel inflammation (eg, ulcerative colitis), or muscle problems (eg, myasthenia gravis)
• you are unable to urinate or you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ryneze 12-Hour Tablets:

Some medical conditions may interact with Ryneze 12-Hour Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a hernia, high blood pressure, nerve problems, prostate gland problems, blockage of your bladder, irregular heartbeat, congestive heart failure or other heart problems, trouble urinating, sleep apnea, asthma, or glaucoma, or you are at risk of developing glaucoma

Some MEDICINES MAY INTERACT with Ryneze 12-Hour Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticholinergic medicines (eg, benztropine), barbiturates (eg, phenobarbital), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Ryneze 12-Hour Tablets’s side effects
• MAOIs (eg, phenelzine) or sodium oxybate (GHB) because the risk of serious side effects, such as high blood pressure or severe drowsiness, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ryneze 12-Hour Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ryneze 12-Hour Tablets:

Use Ryneze 12-Hour Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ryneze 12-Hour Tablets by mouth with or without food.
• Swallow Ryneze 12-Hour Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Ryneze 12-Hour Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
• Do not take an antacid or medicine for diarrhea within 1 hour before or 2 hours after you take Ryneze 12-Hour Tablets.
• If you miss a dose of Ryneze 12-Hour Tablets and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ryneze 12-Hour Tablets.

Important safety information:

• Ryneze 12-Hour Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ryneze 12-Hour Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ryneze 12-Hour Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Ryneze 12-Hour Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
• Ryneze 12-Hour Tablets may reduce sweating. Do not become overheated in hot weather or during exercise or during other activities; heatstroke may occur.
• Ryneze 12-Hour Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Ryneze 12-Hour Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Ryneze 12-Hour Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ryneze 12-Hour Tablets.
• Use Ryneze 12-Hour Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Ryneze 12-Hour Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Ryneze 12-Hour Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ryneze 12-Hour Tablets while you are pregnant. Ryneze 12-Hour Tablets are found in breast milk. Do not breast-feed while taking Ryneze 12-Hour Tablets.

Possible side effects of Ryneze 12-Hour Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; change in appetite; constipation; dizziness; drowsiness; dry mouth; fast heartbeat; nausea; nervousness; ringing in the ears; stomach upset or pain; sun sensitivity; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating; fainting or feeling faint; fever; flushing; hallucinations; seizures; severe clumsiness; severe drowsiness; shortness of breath; sore throat; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include difficulty breathing; extreme dizziness; extreme drowsiness; fixed/large pupils; hot, dry skin; irregular heartbeat; loss of consciousness; mental or mood changes; persistent vomiting; ringing in the ears; seizures.

Proper storage of Ryneze 12-Hour Tablets:

Store at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ryneze 12-Hour Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Ryneze 12-Hour Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Ryneze 12-Hour Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ryneze 12-Hour Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: propafenone (proe PAF e none)
Brand Names: Rythmol, Rythmol SR

What is Rythmol (propafenone)?

Propafenone is in a group of drugs called Class IC anti-arrhythmics. It affects the way your heart beats.

Propafenone is used in certain situations to prevent serious heart rhythm disorders.

Propafenone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Rythmol (propafenone)?

You should not use this medication if you are allergic to propafenone, or if you have untreated or uncontrolled congestive heart failure, a heart condition called “sick sinus syndrome” or “AV block” (unless you have a pacemaker), slow heartbeats or severely low blood pressure, an electrolyte imbalance, or a breathing disorder such as asthma.

Before you take propafenone, tell your doctor if you have congestive heart failure, liver or kidney disease, lupus, arthritis, myasthenia gravis, or if you have had a heart attack within the past 2 years.

You will need to receive your first few doses of propafenone in a hospital setting in case the medication causes serious side effects. Your heart rate will be constantly monitored using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Call your doctor at once if you have a serious side effect such as weak pulse, slow breathing, feeling like you might pass out, feeling short of breath, swelling, rapid weight gain, pale skin, easy bruising or bleeding, unusual weakness, confusion, unusual thoughts or behavior, or seizure.

What should I discuss with my healthcare provider before taking Rythmol (propafenone)?

You should not use this medication if you are allergic to propafenone, or if you have:

• untreated or uncontrolled congestive heart failure;

• a heart condition called “sick sinus syndrome” or “AV block” (unless you have a pacemaker);

• slow heartbeats or severely low blood pressure;

• an electrolyte imbalance; or

• a breathing disorder such as asthma.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take propafenone:

• congestive heart failure;

• liver disease;

• kidney disease;

• lupus;

• arthritis;

• myasthenia gravis; or

• if you have had a heart attack within the past 2 years.

FDA pregnancy category C. It is not known whether propafenone is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Propafenone may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Rythmol (propafenone)?

You will need to receive your first few doses of propafenone in a hospital setting in case the medication causes serious side effects. Your heart rate will be constantly monitored using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart.

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Store propafenone at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include drowsiness, slow heart rate, feeling like you might pass out, or seizure (convulsions).

What should I avoid while taking Rythmol (propafenone)?

Grapefruit and grapefruit juice may increase your blood levels of propafenone which could lead to unwanted side effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Rythmol (propafenone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• feeling short of breath, even with mild exertion;

• swelling, rapid weight gain;

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

• pale skin, easy bruising or bleeding, unusual weakness;

• confusion, unusual thoughts or behavior; or

• seizure.

Less serious side effects may include:

• dizziness;

• unusual or unpleasant taste in your mouth;

• nausea, vomiting;

• warmth, redness, or tingly feeling under your skin;

• constipation;

• headache;

• tired feeling;

• ringing in your ears;

• unusual dreams; or

• blurred vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rythmol (propafenone)?

Many drugs can interact with propafenone. Below is just a partial list. Tell your doctor if you are using:

• cimetidine (Tagamet),

• digoxin (digitalis, Lanoxin);

• ketoconazole (Nizoral);

• orlistat (alli, Xenical);

• quinidine (Quinaglute, Quinidex, Quin-Release);

• rifampin (Rifadin, Rifamate, Rimactane);

• a blood thinner such as warfarin (Coumadin);

• an antidepressant such as desipramine (Norpramin), fluoxetine (Prozac), imipramine (Tofranil), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor);

• HIV or AIDS medication such as ritonavir (Norvir) or saquinavir (Invirase);

• another heart rhythm medication such as amiodarone (Cordarone, Pacerone);

• medicine to treat psychiatric disorders, such as haloperidol (Haldol); or

• a beta-blocker such as atenolol (Tenormin), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others.

This list is not complete and there may be other drugs that can interact with propafenone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about propafenone.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.06. Revision Date: 06/12/2009 9:02:39 AM.

Generic Name: chlorpheniramine and phenylephrine (KLOR fen IR a meen and FEN il EFF rin)
Brand Names: Allan Tannate Pediatric, Allerest PE, AlleRx, BP Allergy JR, C Phen, C Phen Drops, Cardec, Cardec Drops, Ceron, Ceron Drops, Chlor-Mes Jr, ChlorTan D, Cold & Allergy Relief, CP Dec, CP Dec Drops, Dallergy Drops, Dallergy-JR, Ed A-Hist, Ed ChlorPed D, Histadec, Nasohist Pediatric, NoHist, Ny-Tannic, PD-Hist D, PD-Hist D Drops, PediaTan D, Phenchlor Tannate Pediatric, R-Tanna, Relera, Rescon-Jr, Rinate Pediatric, Rondec, Rondec Drops, Rondex, Rondex Drops, Ry-Tann, Rynatan, Rynatan Pediatric, Sildec-PE, Sildec-PE Drops, Sinus & Allergy Maximum Strength, Sinus & Allergy PE, Sonahist, Sudafed PE Sinus & Allergy, Tanahist-D, Tannate Pediatric, Triaminic Cold & Allergy

What is Rynatan Pediatric (chlorpheniramine and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine and phenylephrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Rynatan Pediatric (chlorpheniramine and phenylephrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use chlorpheniramine and phenylephrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and phenylephrine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and phenylephrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.

What should I discuss with my healthcare provider before taking Rynatan Pediatric (chlorpheniramine and phenylephrine)?

Do not use chlorpheniramine and phenylephrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and phenylephrine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have:

• severe or uncontrolled high blood pressure;

• severe coronary artery disease;

• narrow angle glaucoma;

• a stomach ulcer; or

• if you are unable to urinate.

Do not use this medication during an asthma attack.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease;
• liver disease;

• diabetes;

• glaucoma;

• circulation problems;

• heart disease or high blood pressure;

• overactive thyroid;

• a seizure disorder such as epilepsy;

• asthma, emphysema or chronic bronchitis; or

• urination problems or an enlarged prostate.

FDA pregnancy category C. It is not known whether chlorpheniramine and phenylephrine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether chlorpheniramine and phenylephrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

How should I take Rynatan Pediatric (chlorpheniramine and phenylephrine)?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.

Store chlorpheniramine and phenylephrine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause nausea, vomiting, diarrhea, stomach pain, problems with balance or coordination, headache, urination problems, dizziness, feeling excited or irritable, hallucinations (seeing things), metallic taste in your mouth, tremors, fever, flushed face, and seizure (convulsions).

What should I avoid while taking Rynatan Pediatric (chlorpheniramine and phenylephrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and phenylephrine.

Avoid using other medicines that may cause restlessness (such as caffeine, stimulants, diet pills, and decongestants contained in over-the-counter cold medicines). They can add to the stimulant effects of phenylephrine.

Rynatan Pediatric (chlorpheniramine and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using chlorpheniramine and phenylephrine and call your doctor at once if you have any of these serious side effects:

• fast or uneven heart beats;

• feeling light-headed, fainting;

• seizure (convulsions);

• hallucinations (seeing things that are not there); or

• tremors.

Less serious side effects may include:

• heartburn, nausea, vomiting, diarrhea, loss of appetite;

• dry nose or mouth;

• drowsiness, dizziness, weakness, headache;

• dry eyes, blurred vision;

• painful or difficult urination;

• sleep problems (insomnia);

• feeling nervous or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rynatan Pediatric (chlorpheniramine and phenylephrine)?

Sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by chlorpheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications..

Tell your doctor about all other medications you use, especially:

• mecamylamine (Inversine);

• methyldopa (Aldomet);

• reserpine;

• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

• an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and there may be other drugs that can interact with chlorpheniramine and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine and phenylephrine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 7.03. Revision Date: 11/19/2009 11:50:43 AM.