Generic Name: diclofenac (Topical route)

dye-KLOE-fen-ak

Commonly used brand name(s):

In the U.S.

• Flector
• Pennsaid
• Solaraze
• Voltaren

Available Dosage Forms:

• Gel/Jelly
• Solution
• Patch, Extended Release

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For Flector

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and other symptoms of arthritis of the joints (e.g., osteoarthritis), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure osteoarthritis and will help you only as long as you continue to use it.

Diclofenac is also used to treat actinic keratosis, a skin problem that may become cancerous if not treated. The exact way that topical diclofenac helps this condition is unknown.

Diclofenac topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).

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

Before Using Flector

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 diclofenac in the pediatric population. 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 diclofenac in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving diclofenac.

Pregnancy

	Pregnancy Category	Explanation

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.

• Ketorolac

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.

• Ardeparin
• Beta Glucan
• Certoparin
• Dalteparin
• Danaparoid
• Desirudin
• Enoxaparin
• Ginkgo
• Methotrexate
• Nadroparin
• Parnaparin
• Pemetrexed
• Reviparin
• Tacrolimus
• Tinzaparin

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.

• Acetohexamide
• Alacepril
• Amiloride
• Azosemide
• Bemetizide
• Benazepril
• Bendroflumethiazide
• Benzthiazide
• Bumetanide
• Buthiazide
• Candesartan Cilexetil
• Canrenoate
• Captopril
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cilazapril
• Ciprofloxacin
• Citalopram
• Clopamide
• Clopidogrel
• Clovoxamine
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Delapril
• Desvenlafaxine
• Duloxetine
• Enalaprilat
• Enalapril Maleate
• Eprosartan
• Escitalopram
• Ethacrynic Acid
• Femoxetine
• Flesinoxan
• Fluoxetine
• Fluvoxamine
• Fosinopril
• Furosemide
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Hydrochlorothiazide
• Hydroflumethiazide
• Imidapril
• Indapamide
• Irbesartan
• Lisinopril
• Lithium
• Losartan
• Methyclothiazide
• Metolazone
• Milnacipran
• Moexipril
• Nefazodone
• Olmesartan Medoxomil
• Paroxetine
• Pentopril
• Perindopril
• Piretanide
• Polythiazide
• Quinapril
• Quinethazone
• Ramipril
• Sertraline
• Spirapril
• Spironolactone
• Tasosartan
• Telmisartan
• Temocapril
• Tolazamide
• Tolbutamide
• Torsemide
• Trandolapril
• Triamterene
• Trichlormethiazide
• Valsartan
• Venlafaxine
• Xipamide
• Zimeldine
• Zofenopril

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Anemia or
• Bleeding problems or
• Blood clots or
• Edema (fluid retention or body swelling) or
• Heart attack, history of or
• Heart disease (e.g., congestive heart failure) or
• Hypertension (high blood pressure) or
• Kidney disease or
• Stomach ulcers or bleeding, history of or
• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or
• Aspirin sensitivity, history of—Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

• Irritated or scraped skin (for skin patch only)—The effects of diclofenac may be increased if the skin patch is placed on an area of scraped or irritated skin because more medicine is absorbed into the body.

• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of diclofenac

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

Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered.

Diclofenac may cause redness, soreness, scaling, and peeling of the affected skin. Do not stop using this medicine without first checking with your doctor. If the reaction is very uncomfortable, check with your doctor.

This medicine comes with a medication guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

To use the topical gel:

• Wash your hands before and after using this medicine.
• Apply the medicine very carefully to clean, dry skin, and avoid getting any in your eyes, nose, or mouth.
• Do not apply this medicine to areas with broken skin or open wounds, infection, or severely peeling skin.
• Apply enough medicine each time to cover the entire affected area.
• Do not use heating pads or cover the treated area with a bandage unless your doctor has told you to.
• Do not use cosmetics (e.g., makeup or sunscreens) or other skin care products on the same skin areas where you have applied this medicine.
• After applying this medicine, do not shower, bathe, or wash the affected area for at least one hour.
• Wait at least 10 minutes before covering the treated skin with gloves or clothing.

To use the skin patch:

• Use this medicine exactly as directed by your doctor. It will work only if applied correctly.
• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands. If it gets into your eyes, wash the eyes right away with water.
• Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
• Apply the patch to a clean, dry, intact skin area. Choose an area with little or no hair and free of scars, cuts, or irritation. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
• Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well. If the patch begins to peel off, the edges of the patch may be taped down.
• Do not use the patch when you take a bath or shower.

To help you remember to use your medicine, try to get into the habit of using it at regular times. If you are using the transdermal system (skin patch), try to change it at the same time and day of the week.

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 topical dosage form (gel):
  • For actinic keratosis:
    • Adults—Apply to affected skin two times per day.
    • Children—Use and dose must be determined by your doctor.
  • For osteoarthritis of the hands, elbows, or wrists:
    • Adults—Apply 2 grams to the affected skin areas 4 times per day (a total of 8 grams each day). However, the total dose should not exceed 32 grams per day over all affected joints.
    • Children—Use and dose must be determined by your doctor.
  • For osteoarthritis of the knees, ankles, or feet:
    • Adults—Apply 4 grams to the affected skin areas four times per day (a total of 16 grams each day). However, the total dose should not exceed 32 grams per day over all affected joints.
    • Children—Use and dose must be determined by your doctor.

• For transdermal dosage form (skin patch):
  • For acute pain:
    • Adults—One patch applied to the painful area two times per day.
    • Children—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.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

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.

After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Precautions While Using Flector

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure this medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting of blood or material that looks like coffee grounds; or yellow skin or eyes. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop using this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.

If your symptoms become worse, check with your doctor.

While using this medicine, your skin may become more sensitive to sunlight than usual, and too much sunlight may increase the effects of the medicine. During this period of time:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat and sunglasses.
• Do not use a sunlamp or tanning bed or booth.
• Make sure you have discussed the use of a sun block product with your doctor.

If you have a severe reaction from the sun, check with your doctor.

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for awhile, or to change to a different nonsteroidal antiinflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Flector 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:

More common

• Application site reactions, including skin rash, pain, tingling, or burning sensation
• flu-like syndrome (body ache; headache; fever, with or without chills)
• itching skin

Less common or rare

• Application site reactions, including swelling; increased skin sensitivity; itching, redness, or pain caused by reaction from exposure to sun
• blood in the urine
• cough
• decrease in body movement
• dry, itching, or burning eyes
• eye pain
• fever
• headaches, including migraines
• high blood pressure
• increased sensitivity of eyes to light
• infection
• nasal congestion
• pain or tenderness around the eyes and cheekbones
• redness or swelling of the eyes
• shortness of breath
• skin rash other than at the application site
• sore throat
• tightness in the chest
• troubled breathing
• ulcers or sores on the skin, other than at the application site
• wheezing

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

• Burning skin
• dry skin
• red skin
• scaly skin
• thickened skin
• tingling skin

Less common

• Acne
• back pain
• belching
• bleeding skin
• chest pain
• diarrhea
• heartburn
• indigestion
• joint pain
• lack or loss of strength
• loss or thinning of the hair
• muscle pain
• neck pain
• runny nose
• stomach upset or pain

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: Diclofenac (dye-KLOE-fen-ak)
Brand Name: Flector

Flector Topical Patch is used for:

Treating pain caused by minor strains, sprains, and bruises. It may also be used for other conditions as determined by your doctor.

Flector Topical Patch is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use Flector Topical Patch if:

• you are allergic to any ingredient in Flector Topical Patch
• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) due to aspirin or an NSAID (eg, ibuprofen, celecoxib)
• you have recently had or will be having bypass heart surgery
• your skin at the application site is broken or damaged
• you have severe kidney problems
• you are in the last 3 months of pregnancy

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

Before using Flector Topical Patch:

Some medical conditions may interact with Flector Topical Patch. 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 skin problems (eg, eczema or skin inflammation), or if you have an infection, burn, or wound at the application site
• if you have a history of kidney or liver problems, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
• if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
• if you have high blood pressure, blood disorders (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases
• if you have poor health, you smoke, drink alcohol, or have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Flector Topical Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased
• Probenecid because it may increase the risk of Flector Topical Patch’s side effects
• Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Flector Topical Patch
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Flector Topical Patch

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flector Topical Patch 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 Flector Topical Patch:

Use Flector Topical Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Flector Topical Patch comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Flector Topical Patch refilled.
• Wash your hands before and right after you handle Flector Topical Patch.
• Do NOT apply the patch to broken, damaged, or irritated skin.
• Do not remove Flector Topical Patch from the pouch until you are ready to apply it. Be sure to reseal the pouch right away to keep unused patches from drying out.
• To apply the patch, first remove the protective liner. Apply the patch to the most painful area, unless your doctor tells you otherwise. Press firmly and make sure the edges stick well to the skin.
• Do not wear the patch while taking a bath or shower. Take your bath or shower between the time when you remove a used patch and apply a new one.
• If the patch begins to fall off, tape the edges down to secure it.
• After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.
• If you miss a dose of Flector Topical Patch, use 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 use 2 patches at once

Ask your health care provider any questions you may have about the proper use of Flector Topical Patch.

Important safety information:

• Flector Topical Patch may cause dizziness or drowsiness. Theses effects may be worse if you take it with alcohol or certain medicines. Use Flector Topical Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Flector Topical Patch is for use on the skin only. Do not get it in your eyes, nose, or mouth. If you get Flector Topical Patch in your eye, wash the eye out with water or saline right away. Contact your doctor if irritation persists for more than 1 hour.
• Do NOT use more than 1 patch at a time or use Flector Topical Patch for longer than prescribed without checking with your doctor.
• If irritation occurs at the application site, remove the patch and contact your doctor.
• Serious stomach ulcers or bleeding can occur with the use of Flector Topical Patch. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; or vomit that looks like blood or coffee grounds.
• Flector Topical Patch is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not take aspirin while you are using Flector Topical Patch unless your doctor tells you to.
• Lab tests, including kidney function, liver function, blood electrolyte levels, complete blood cell counts, and blood pressure, may be performed while you use Flector Topical Patch. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Flector Topical Patch with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
• Flector Topical Patch should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Flector Topical Patch may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Flector Topical Patch while you are pregnant. It is not known if Flector Topical Patch is found in breast milk. Do not breast-feed while taking Flector Topical Patch.

Possible side effects of Flector Topical Patch:

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:

Minor burning, itching, or irritation at the application site.

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

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent irritation at the application site; severe or persistent stomach pain or nausea; severe vomiting or diarrhea; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes); unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; wheezing.

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. Flector Topical Patch may be harmful if swallowed.

Proper storage of Flector Topical Patch:

Store Flector Topical Patch at 77 degrees F (25 degrees C) in the sealed pouch. Brief storage 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. Throw away any unused patches 3 months after opening the pouch. The pouch is not child-resistant. Keep Flector Topical Patch out of the reach of children and away from pets.

General information:

• If you have any questions about Flector Topical Patch, please talk with your doctor, pharmacist, or other health care provider.
• Flector Topical Patch 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 Flector Topical Patch. 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: diclofenac transdermal (dye KLOE fen ak)
Brand Names: Flector Patch

What is Flector Patch (diclofenac transdermal)?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Diclofenac transdermal skin patch is used to treat pain caused by minor sprains, strains, or bruising.

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

What is the most important information I should know about Flector Patch (diclofenac transdermal)?

Do not use this medication if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID). Do not use diclofenac just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have heart disease, congestive heart failure, high blood pressure, a history of heart attack or stroke, a history of stomach ulcer or bleeding, liver or kidney disease, a blood clotting disorder, asthma or polyps in your nose, or if you smoke.

While the risk of absorbing diclofenac transdermal into your bloodstream is low, an NSAID may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac transdermal, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What should I discuss with my healthcare provider before using Flector Patch (diclofenac transdermal)?

While the risk of absorbing diclofenac transdermal into your bloodstream is low, an NSAID can cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac transdermal, especially in older adults.

Do not use this medication if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another NSAID. Do not use diclofenac just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

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

• a history of drug allergies;

• a history of heart attack, stroke, or blood clot;

• heart disease, congestive heart failure, high blood pressure;

• a history of stomach ulcer or bleeding;

• liver or kidney disease;

• a bleeding or blood clotting disorder;

• asthma;

• polyps in your nose; or

• if you smoke.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Using diclofenac during the last 3 months of pregnancy may harm the unborn baby. Do not use this medication during pregnancy unless your doctor has told you to. It is not known whether diclofenac transdermal 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.

How should I use Flector Patch (diclofenac transdermal)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Using extra skin patches will not make the medication more effective. Follow the directions on your prescription label.

Apply the skin patch directly to the area of pain. The skin patch can be worn for up to 12 hours and then removed. Apply a new patch at that time if pain continues. Do not wear a skin patch while taking a bath or shower or while swimming.

Do not apply diclofenac transdermal on an open skin wound, or on areas of eczema, infection, skin rash, or burn injury. Wash your hands after applying or removing a skin patch.

If the patch falls off, try sticking it back on, or use medical tape to hold it on.

After removing a skin patch fold it in half, sticky side in, and throw it away in a place where children or pets cannot get to it. Keep both used and unused skin patches out of the reach of children or pets.

If you use this medication long-term, your blood may need to be tested often. Your blood pressure may also need to be checked. Visit your doctor regularly.

Store at room temperature away from moisture and heat. Do not take a skin patch out of the patch envelope until you are ready to use it. Reseal the envelope for storage.

What happens if I miss a dose?

Apply a skin patch as soon as you remember, and wear it for 12 hours before applying a new one. Do not use extra patches to make up the missed dose. Do not wear a diclofenac skin patch for longer than 12 hours.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Flector Patch (diclofenac transdermal)?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin, oral (pill form) diclofenac (Cataflam, Voltaren), or other NSAIDs without your doctor’s advice. This includes ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others.

Ask a doctor or pharmacist before using any over-the-counter cold, allergy, or pain medicine. Many combination medicines contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen. Avoid getting this medication near your eyes. If this does happen, rinse with water and call your doctor if you have eye irritation that lasts longer than 1 hour.

Flector Patch (diclofenac transdermal) 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.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• fever, chills, body aches, flu symptoms;

• pale or yellowed skin, dark colored urine, confusion;

• swelling or rapid weight gain;

• urinating less than usual or not at all;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

• mild nausea, vomiting;

• diarrhea, constipation;

• upset stomach, heartburn, gas;

• dizziness; or

• mild itching, burning, redness, or other skin irritation where the patch was worn.

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 Flector Patch (diclofenac transdermal)?

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

• a blood thinner such as warfarin (Coumadin);

• cyclosporine (Gengraf, Neoral, Sandimmune);

• lithium (Eskalith, Lithobid);

• methotrexate (Rheumatrex, Trexall);

• a diuretic (water pill);

• steroids (prednisone and others); or

• heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

It is not likely that other drugs you take orally or inject will have an effect on topically applied diclofenac. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about diclofenac transdermal.

• 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: 1.01. Revision Date: 04/23/2010 3:36:19 PM.

Generic Name: Sodium Phosphates (SOE-dee-um FOS-fates)
Brand Name: Fleet

Fleet Enema is used for:

Treating constipation or cleansing the bowel before certain medical procedures. It may also be used for other conditions as determined by your doctor.

Fleet Enema is a saline laxative enema. It works by pulling water from the body into the bowel, which helps to soften the stool and cause a bowel movement.

Do NOT use Fleet Enema if:

• you are allergic to any ingredient in Fleet Enema
• you have a blockage of the bowel or other severe bowel problems, congestive heart failure, kidney failure, or too much phosphate in the blood

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

Before using Fleet Enema:

Some medical conditions may interact with Fleet Enema. 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 are on a sodium-restricted diet or have a history of stomach or bowel problems
• if you have appendicitis, liver or kidney problems, high blood pressure, low parathyroid function, bone problems (eg, osteomalacia), muscle problems (eg, rhabdomyolysis), pancreas problems, a kidney or bladder infection, kidney stones, electrolyte problems (eg, low blood calcium), a colostomy, nausea, vomiting, stomach pain, or a sudden change in bowel movements lasting longer than 2 weeks
• if you have already used a laxative for more than 1 week

Some MEDICINES MAY INTERACT with Fleet Enema. However, no specific interactions with Fleet Enema are known at this time.

Ask your health care provider if Fleet Enema 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 Fleet Enema:

Use Fleet Enema as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Remove the protective shield from the enema tip before inserting.
• With steady pressure, gently insert the enema tip into the rectum with a slight side-to-side movement, with the tip pointing toward the navel. Insertion may be easier if you bear down, as if having a bowel movement. This helps relax the muscles around the anus.
• Do not force the enema tip into the rectum. This can cause injury.
• Squeeze the bottle until nearly all the liquid is gone. It is not necessary to empty the bottle completely. It contains more liquid than needed.
• Remove the tip from the rectum and maintain the position until the urge to evacuate is strong (usually 2 to 5 minutes).
• Do not use more than 1 enema in 24 hours.
• If you miss a dose of Fleet Enema, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Fleet Enema.

Important safety information:

• Stop using Fleet Enema and contact your doctor if you have rectal bleeding or fail to have a bowel movement after using Fleet Enema. These symptoms may indicate a serious condition.
• Fleet Enema should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fleet Enema while you are pregnant. It is not known if Fleet Enema is found in breast milk. If you are or will be breast-feeding while you use Fleet Enema, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fleet Enema:

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:

Anal irritation; diarrhea; gas; nausea; stomach cramps.

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); blood in the stool; continued constipation; dizziness; vomiting; 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.

Proper storage of Fleet Enema:

Store Fleet Enema at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Fleet Enema out of the reach of children and away from pets.

General information:

• If you have any questions about Fleet Enema, please talk with your doctor, pharmacist, or other health care provider.
• Fleet Enema 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 Fleet Enema. 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: flecainide (FLEK a nide)
Brand Names: Tambocor

What is flecainide?

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

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

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

What is the most important information I should know about flecainide?

You should not use this medication if you are allergic to flecainide, or if you have certain heart conditions, especially “AV block” (unless you have a pacemaker).

Before using flecainide, tell your doctor if you have congestive heart failure, a heart condition called “sick sinus syndrome,” an electrolyte imbalance, liver disease, kidney disease, if you have a pacemaker, or if you have had a heart attack within the past 2 years.

You will need to receive your first few doses of flecainide 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, fast or uneven heartbeat, feeling like you might pass out, feeling short of breath, swelling, rapid weight gain, confusion, extreme thirst, increased urination, muscle weakness, or jaundice (yellowing of the skin or eyes).

What should I discuss with my healthcare provider before taking flecainide?

You should not use this medication if you are allergic to flecainide, or if you have certain heart conditions, especially “AV block” (unless you have a pacemaker).

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

• congestive heart failure;

• a heart condition called “sick sinus syndrome”;

• an electrolyte imbalance;

• liver disease;

• kidney disease;

• if you have a pacemaker; or

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

If you have any of these conditions, you may need a dose adjustment or special tests to safely use flecainide.

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. Flecainide 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.

How should I take flecainide?

You will need to receive your first few doses of flecainide 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 flecainide exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. 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 flecainide at room temperature away from moisture, heat, and light.

See also: Flecainide dosage in more detail

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 nausea, vomiting, slow heart rate, feeling like you might pass out, or seizure (convulsions).

What should I avoid while taking flecainide?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using flecainide.

Flecainide 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:

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

• dizziness, fainting, fast or pounding heartbeat;

• feeling short of breath, even with mild exertion;

• swelling, rapid weight gain;

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

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

• jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• dizziness;

• tremor or shaking;

• headache;

• anxiety or depression;

• vision problems;

• nausea, vomiting, stomach pain;

• diarrhea, constipation; or

• numbness or tingling.

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.

Flecainide Dosing Information

Usual Adult Dose for Ventricular Tachycardia:

Initial dose: 100 mg orally every 12 hours.
Maintenance dose: May be increased in increments of 50 mg bid every 4 days until efficacy is achieved. Most patients with SUSTAINED VT do not require more than 150 mg every 12 hours (300 mg/day), and the maximum dose recommended is 400 mg/day.

Usual Adult Dose for Atrial Fibrillation:

Initial dose: 50 mg orally every 12 hours.
Maintenance dose: May be increased in increments of 50 mg bid every 4 days until efficacy is achieved.

Usual Adult Dose for Atrial Flutter:

Initial dose: 50 mg orally every 12 hours.
Maintenance dose: May be increased in increments of 50 mg bid every 4 days until efficacy is achieved.

Usual Adult Dose for Wolff-Parkinson-White Syndrome:

Initial dose: 50 mg orally every 12 hours.
Maintenance dose: May be increased in increments of 50 mg bid every 4 days until efficacy is achieved.

Usual Adult Dose for Paroxysmal Supraventricular Tachycardia:

Initial dose: 50 mg orally every 12 hours.
Maintenance dose: May be increased in increments of 50 mg bid every 4 days until efficacy is achieved.

What other drugs will affect flecainide?

Before taking flecainide, tell your doctor if you are taking any of the following medicines:

• cimetidine (Tagamet),

• digoxin (digitalis, Lanoxin);

• a diuretic (water pill);

• verapamil (Verelan, Calan, Isoptin);

• seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), or phenytoin (Dilantin);

• other heart rhythm medications such as amiodarone (Cordarone), disopyramide (Norpace), or quinidine (Quinaglute, Quinidex); 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 flecainide. 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 flecainide.

• 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: 3.09. Revision Date: 4/12/2009 4:36:35 PM.

FLEK-a-nide

Commonly used brand name(s):

In the U.S.

• Tambocor

Available Dosage Forms:

• Capsule, Extended Release
• Tablet

Therapeutic Class: Antiarrhythmic, Group IC

Chemical Class: Amino Amide

Uses For flecainide

Flecainide belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular heartbeats to a normal rhythm.

Flecainide produces its helpful effects by slowing nerve impulses in the heart and making the heart tissue less sensitive.

There is a chance that flecainide may cause new or make worse existing heart rhythm problems when it is used. Since it has been shown to cause severe problems in some patients, it is only used to treat serious heart rhythm problems. Discuss this possible effect with your doctor.

flecainide is available only with your doctor’s prescription.

Before Using flecainide

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 flecainide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to flecainide 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

Studies on flecainide have been done only in adult patients, and there is no specific information comparing use of flecainide in children with use in other age groups.

Geriatric

Elderly people are especially sensitive to the effects of flecainide. Flecainide may be more likely to cause irregular heartbeat in the elderly.

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 flecainide 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.

• Bepridil
• Cisapride
• Levomethadyl
• Mesoridazine
• Pimozide
• Ritonavir
• Saquinavir
• Terfenadine
• Thioridazine
• Tipranavir
• Ziprasidone

Using flecainide 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.

• Acecainide
• Ajmaline
• Alatrofloxacin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Aprindine
• Arbutamine
• Arsenic Trioxide
• Astemizole
• Azimilide
• Balofloxacin
• Bendroflumethiazide
• Bretylium
• Chloral Hydrate
• Chloroquine
• Chlorothiazide
• Chlorpromazine
• Chlorthalidone
• Ciprofloxacin
• Clarithromycin
• Clinafloxacin
• Darifenacin
• Darunavir
• Delavirdine
• Desipramine
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Droperidol
• Duloxetine
• Enflurane
• Enoxacin
• Erythromycin
• Etravirine
• Flecainide
• Fleroxacin
• Fluconazole
• Flumequine
• Fluoxetine
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Grepafloxacin
• Halofantrine
• Haloperidol
• Halothane
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroquinidine
• Ibutilide
• Imipramine
• Isoflurane
• Isradipine
• Levofloxacin
• Lidocaine
• Lidoflazine
• Lomefloxacin
• Lorcainide
• Lumefantrine
• Mefloquine
• Metolazone
• Moxifloxacin
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Pazopanib
• Pefloxacin
• Pentamidine
• Pirmenol
• Polythiazide
• Prajmaline
• Prilocaine
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Protriptyline
• Prulifloxacin
• Quetiapine
• Quinidine
• Risperidone
• Rufloxacin
• Sematilide
• Sertindole
• Sertraline
• Sotalol
• Sparfloxacin
• Spiramycin
• Sulfamethoxazole
• Sultopride
• Tedisamil
• Telithromycin
• Temafloxacin
• Tosufloxacin
• Trichlormethiazide
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Vasopressin
• Zolmitriptan
• Zotepine

Using flecainide 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.

• Amiodarone
• Bupropion
• Cimetidine
• Clozapine
• Digoxin
• Paroxetine
• Propranolol
• Protriptyline
• Verapamil

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Congestive heart failure—Flecainide may make this condition worse

• Kidney disease or
• Liver disease—Effects of flecainide may be increased because of slower removal from the body

• Recent heart attack—Risk of irregular heartbeats may be increased

• If you have a pacemaker—Flecainide may interfere with the pacemaker and require more careful follow-up by the doctor

Proper Use of flecainide

Take flecainide exactly as directed by your doctor, even though you may feel well. Do not take more medicine than ordered.

flecainide works best when there is a constant amount in the blood. To help keep this amount constant, do not miss any doses. Also, it is best to take the doses 12 hours apart, in the morning and at night , unless otherwise directed by your doctor. If you need help in planning the best times to take your medicine, check with your health care professional.

Dosing

The dose of flecainide 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 flecainide. 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 oral dosage form (tablets):
  • For correcting irregular heartbeat:
    • Adults—50 to 150 milligrams (mg) every twelve hours.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of flecainide, 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.

Precautions While Using flecainide

It is important that your doctor check your progress at regular visits to make sure the medicine is working properly. This will allow for changes to be made in the amount of medicine you are taking, if necessary.

Your doctor may want you to carry a medical identification card or bracelet stating that you are using flecainide.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking flecainide.

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

If you have been using flecainide regularly for several weeks, do not suddenly stop using it. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

flecainide 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 as soon as possible if any of the following side effects occur:

Less common

• Chest pain
• irregular heartbeat
• shortness of breath
• swelling of feet or lower legs
• trembling or shaking

Rare

• Yellow eyes or skin

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

• Blurred vision or seeing spots
• dizziness or lightheadedness

Less common

• Anxiety or mental depression
• constipation
• headache
• nausea or vomiting
• skin rash
• stomach pain or loss of appetite
• unusual tiredness or weakness

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Brand names: Tambocor

Why is Flecainide acetate prescribed?

Tambocor is prescribed to treat certain heart rhythm disturbances, including paroxysmal atrial fibrillation (a sudden attack or worsening of irregular heartbeat in which the upper chamber of the heart beats irregularly and very rapidly) and paroxysmal supraventricular tachycardia (a sudden attack or worsening of an abnormally fast but regular heart rate that occurs in intermittent episodes).

Most important fact about Flecainide acetate

Tambocor may sometimes cause or worsen heartbeat irregularities and certain heart conditions, such as heart failure (the inability of the heart to sustain its workload of pumping blood). Before prescribing Tambocor, your doctor will weigh the drug’s risks and benefits. Your condition will be monitored throughout your treatment.

How should you take Flecainide acetate?

In almost every case, your doctor will initiate Tambocor therapy in the hospital.

Take Tambocor exactly as prescribed by your doctor. Serious heartbeat disturbances may result if you do not follow your doctor’s instructions, if you miss any regular doses, or if you increase or decrease the dosage without consulting your doctor.

Your doctor may order regular blood tests to monitor your therapy.

• If you miss a dose…
  Take it as soon as you remember if it is within 6 hours of your scheduled time. If you do not remember until later, skip the dose you missed and go back to your regular schedule. Do not take 2 doses at once.

• Storage instructions…
  Store at room temperature in a tightly closed container, away from light.

What side effects may occur?

Tambocor has a wide variety of possible effects on the heart, including new or worsened heartbeat abnormalities, heart attack, congestive heart failure, and heart block—an interference with the heart’s contraction. If any develop, inform your doctor immediately. Only your doctor can determine whether it is safe for you to continue taking Tambocor.

Why should Flecainide acetate not be prescribed?

Your doctor should not prescribe Tambocor if you have ever had an allergic reaction to it or you are sensitive to it, if you have heart block (without a pacemaker), or if your heart cannot supply enough blood to the body.

Special warnings about Flecainide acetate

If you have a pacemaker, you should be monitored very closely while taking Tambocor—your pacemaker may need to be adjusted.

If you have liver disease, Tambocor could build up in your system. Your doctor will prescribe the drug only if the benefits outweigh the risks. In addition, you should have frequent blood tests to make sure your dosage is not too high.

If you have a history of congestive heart failure or a weak heart, you may be at increased risk for dangerous cardiac side effects from Tambocor.

If you have very alkaline urine, perhaps caused by a kidney condition or by a strict vegetarian diet, your body will tend to process and eliminate Tambocor rather slowly and you may need a lower-than-average dosage.

If the potassium levels in your blood are too high or too low, your doctor will want to correct the condition before allowing you to take Tambocor.

If you have kidney failure, your doctor will want to watch you closely.

Possible food and drug interactions when taking Flecainide acetate

If Tambocor is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Tambocor with the following:

Amiodarone (Cordarone)
Beta blockers (blood pressure drugs such as Inderal, Tenormin, and Sectral)
Carbamazepine (Tegretol)
Cimetidine (Tagamet)
Diltiazem (Cardizem)
Disopyramide (Norpace)
Nifedipine (Procardia)
Phenobarbital
Phenytoin (Dilantin)
Quinidine (Quinidex)
Verapamil (Calan, Isoptin)

Special information if you are pregnant or breastfeeding

The effects of Tambocor during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. Tambocor should be used during pregnancy only if the benefit justifies the potential risk to the unborn child. Tambocor appears in breast milk. Check with your doctor before breastfeeding your baby.

Recommended dosage for Flecainide acetate

ADULTS

Treatment with Tambocor almost always begins in the hospital.

The usual starting dose is 50 to 100 milligrams every 12 hours, depending on the condition under treatment. Every 4 days, your doctor may increase your dose by 50 milligrams every 12 hours until your condition is under control.

CHILDREN

Children’s dosage is based on body surface area and is always supervised by a cardiac physician.

Overdosage

An overdose of Tambocor is likely to cause slowed or rapid heartbeat, other cardiac problems, fainting, low blood pressure, nausea, vomiting, convulsions, and heart failure. Taken even in moderate excess, Tambocor may have serious consequences and can be fatal. If you suspect an overdose, seek medical attention immediately.

Brand names: Urispas

Why is Flavoxate hydrochloride prescribed?

Urispas prevents spasms in the urinary tract and relieves the painful or difficult urination, urinary urgency, excessive nighttime urination, pubic area pain, frequency of urination, and inability to hold urine caused by urinary tract infections. Urispas is taken in combination with antibiotics to treat the infection.

Most important fact about Flavoxate hydrochloride

Urispas can cause blurred vision and drowsiness. Be careful driving, operating machinery, or performing any activity that requires complete mental alertness until you know how you will react to Flavoxate hydrochloride.

How should you take Flavoxate hydrochloride?

Take Flavoxate hydrochloride exactly as prescribed. Urispas may make your mouth dry. Sucking on a hard candy, chewing gum, or melting bits of ice in your mouth can provide relief.

• If you miss a dose…
  Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

• Storage instructions…
  Store away from heat, light, and moisture.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, notify your doctor as soon as possible. Only your doctor can determine whether it is safe for you to continue taking Urispas.

• Side effects may include:
  Allergic skin reactions, including hives, blurred vision and vision changes, drowsiness, dry mouth, fluttery heartbeat, headache, high body temperature, mental confusion (especially in the elderly), nausea, nervousness, painful or difficult urination, rapid heartbeat, vertigo, vomiting

Why should Flavoxate hydrochloride not be prescribed?

You should not take Urispas if you have stomach or intestinal blockage, muscle relaxation problems (especially the sphincter muscle), abdominal bleeding, or urinary tract blockage.

Special warnings about Flavoxate hydrochloride

Use Urispas cautiously if you have the eye condition known as glaucoma.

Possible food and drug interactions when taking Flavoxate hydrochloride

No interactions involving Urispas have been noted.

Special information if you are pregnant or breastfeeding

The effects of Urispas during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. Urispas may appear in breast milk and could affect a nursing infant. If Flavoxate hydrochloride is essential to your health, your doctor may advise you to stop breastfeeding until your treatment is finished.

Recommended dosage for Flavoxate hydrochloride

ADULTS AND CHILDREN OVER AGE 12

The usual dose of Urispas is one or two 100-milligram tablets 3 or 4 times a day.

When your symptoms have improved, your doctor may reduce the dosage.

CHILDREN

Safety and effectiveness of Urispas in children under 12 years of age have not been established.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose of Urispas, seek medical attention immediately.

• Symptoms of Urispas overdose may include:
  Convulsions, decreased ability to sweat, (warm, red skin, dry mouth, and increased body temperature), hallucinations, increased heart rate and blood pressure, mental confusion

Generic Name: flax (FLACKS)
Brand names: Flax Seed Oil, Flax Oil

What is flax?

The use of flax in cultural and traditional settings may differ from concepts accepted by current Western medicine. When considering the use of herbal supplements, consultation with a primary health care professional is advisable. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial, and coordination of treatment among all health care providers involved may be advantageous.

Flax is also known as Linum usitatissimum, flaxseed, linseed, lint bells, linum, and winterlien.

Flax has been used most commonly as a laxative. Flax has also been used to reduce cholesterol levels, to slow prostate cancer growth before surgery, and topically for skin irritation.

Flax has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of flax may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. There have been instances where herbal/health supplements have been sold which were contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Flax may also have uses other than those listed in this medication guide.

What is the most important information I should know about flax?

Do not take flax internally without first talking to your doctor if you have a narrowing of the esophagus or another stomach area, an intestinal obstruction, or other stomach or intestinal problems. Since flax swells in the stomach, it may be dangerous if used by people with certain intestinal problems. Do not take flax internally without first talking to your doctor if you have prostate problems or difficulty with urination.

Flax has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of flax may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. There have been instances where herbal/health supplements have been sold which were contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Who should not take flax?

Do not take flax internally without first talking to your doctor if you have a narrowing of the esophagus or another stomach area, an intestinal obstruction, or other stomach or intestinal problems. Since flax swells in the stomach, it may be dangerous if used by people with certain intestinal problems. Do not take flax internally without first talking to your doctor if you have prostate problems or difficulty with urination.

Before taking flax, talk to your doctor, pharmacist, or health care professional if you have allergies (especially to plants), have any medical condition, or if you take other medicines or other herbal/health supplements. Flax may not be recommended in some situations.

Do not take flax without first talking to your doctor if you are pregnant or could become pregnant. It is not known whether flax will harm an unborn baby. Do not take flax without first talking to your doctor if you are breast-feeding a baby. It is also not known whether flax will harm a nursing infant. There is no information available regarding the use of flax by children. Do not give any herbal/health supplement to a child without first talking to the child’s doctor.

How should I take flax?

The use of flax in cultural and traditional settings may differ from concepts accepted by current Western medicine. When considering the use of herbal supplements, consultation with a primary health care professional is advisable. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial, and coordination of treatment among all health care providers involved may be advantageous.

If you choose to take flax, use it as directed on the package or as directed by your doctor, pharmacist, or other health care provider.

Standardized extracts, tinctures, and solid formulations of herbal/health supplements may provide a more reliable dose of the product.

Take the pill forms of flax with a full glass of water.

To ensure the correct dose, measure the liquid forms of flax with a dropper or a dose-measuring spoon or cup.

If you are taking flax internally, be sure to drink plenty of fluid. Too little fluid can lead to a blockage of flax in the intestines. Topical forms of flax are intended for external use only. Do not use different formulations (e.g., tablets, liquids, and others) of flax at the same time, unless specifically directed to do so by a health care professional. Using different formulations together increases the risk of an overdose of flax.

Store flax as directed on the package. In general, flax should be protected from light.

What happens if I miss a dose?

No information is available regarding a missed dose of flax. Consult your doctor, pharmacist, or health care professional if you require further information.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a flax overdose are not known.

What should I avoid while taking flax?

There are no restrictions on food, beverages, or activity while taking flax, unless otherwise directed by your health care provider.

Flax side effects

Although rare, allergic reactions to flax may occur. Stop taking flax and seek emergency medical attention if you experience symptoms of a serious allergic reaction including difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives.

Other less serious side effects have not been reported, although they may 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 flax?

Do not take any other medication at the same time as flax without first talking to your doctor or health care provider. Flax may decrease the absorption of other drugs when taken together.

Interactions between flax and other prescription or over-the-counter medicines or herbal/health supplements may also occur. Talk to your doctor, pharmacist, or health care professional before taking flax if you are taking any other medicines or supplements.

Where can I get more information?

• Your doctor, pharmacist, or health care provider may have more information about flax.

• Consultation with a licensed health care professional is advisable before using any herbal/health supplement. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial and coordination of treatment among all health care providers involved may be advantageous. Remember, keep this and all other prescription drug products, over-the-counter drug products, and herbal/health supplements out of the reach of children.
• 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 4:44:03 PM.

Generic Name: Flaxseed (Not applicable.)
Brand Name: Generics only. No brands available.

Flaxseed is used for:

Constipation and stomach irritation. It has also been used for pain and inflammation due to arthritis and as a supplement to decrease total cholesterol and low-density lipoprotein (LDL) cholesterol. It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.

Flaxseed is an herbal product. It works by providing an essential fatty acid that benefits the digestive tract and heart.

Do NOT use Flaxseed if:

• you are allergic to any ingredient in Flaxseed
• you have ileus or a history of intestinal blockage of any type
• you have swelling or closure of the esophagus
• you are pregnant

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

Before using Flaxseed:

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

• if you are 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 inflammation of the bowel (eg, Crohn disease), heart disease or other heart problems, or high blood pressure, or you are taking medicines for any of these conditions

Some MEDICINES MAY INTERACT with Flaxseed. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flaxseed 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 Flaxseed:

Use Flaxseed as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dosing depends on the use and the source of the product.
• Use as directed on the package, unless instructed otherwise by your doctor.
• Drinking extra fluids while you are taking flaxseed is recommended.
• Do not take flaxseed at the same time you take any other medicines prescribed by your doctor. Do not take this product if it has a bad smell or bitter taste.
• If you miss taking a dose of Flaxseed for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use Flaxseed.

Important safety information:

• The immature seeds of flax are poisonous. To avoid taking immature seeds, never use a flax product unless it is designed for human consumption.
• If you take any prescription medicines and you notice a decreased effect, report this to your doctor as soon as possible.
• If you are taking flaxseed to reduce cholesterol or LDL, talk with your doctor or pharmacist about other cholesterol-lowering therapies that are proven to reduce the risk of heart disease and improve survival.
• Check with your doctor before you begin taking any new medicine, either prescription or over-the-counter, including laxatives, stool softeners, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs; eg, ibuprofen).
• This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.
• PREGNANCY and BREAST-FEEDING: Flaxseed may cause harm to the human fetus. Do not take flaxseed if you are pregnant. Do not breast-feed while you are taking flaxseed.

Possible side effects of Flaxseed:

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:

Gas; mild diarrhea; nausea.

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); slightly bluish, grayish, slate-like, or dark purple discoloration of the skin.

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 fast heartbeat; paralysis; seizures; shortness of breath; unsteadiness when walking; weakness.

Proper storage of Flaxseed:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Flaxseed out of the reach of children and away from pets.

General information:

• If you have any questions about Flaxseed, please talk with your doctor, pharmacist, or other health care provider.
• Flaxseed 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 Flaxseed. 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.