Generic Name: Abciximab (ab-SIKS-ih-mab)
Brand Name: ReoPro

Abciximab is used for:

Preventing the formation of blood clots in the heart that may occur during procedures to open blocked arteries in the heart known as percutaneous coronary intervention (eg, balloon angioplasty, atherectomy, stent placement). It is also used in patients who have severe chest pain with heart disease (unstable angina) when percutaneous coronary intervention is planned. Abciximab is used in combination with other medicines.

Abciximab is an antithrombotic. It works by preventing the clumping of blood-clotting cells (called platelets) in the blood.

Do NOT use Abciximab if:

• you are allergic to any ingredient in Abciximab or to specific disease-fighting protein substances called murine (mouse) monoclonal antibodies
• you have had active internal bleeding; recent (within 6 weeks) gastrointestinal or genitourinary bleeding; trauma (within 2 years) to your head or spine; high blood pressure or problems with your blood, including bleeding easily or a stroke; low blood platelet count (known as thrombocytopenia); or recent (within 6 weeks) major surgery or trauma
• you have had a growth or cancer of the brain or problems with blood vessels in the brain, blood vessel inflammation (vasculitis), or problems with your eyes, liver, or kidneys
• you are or will be receiving dextran by injection
• you are receiving or have received an anticoagulant (eg, warfarin) within the last 7 days

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

Before using Abciximab:

Some medical conditions may interact with Abciximab. 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 stomach ulcers or other stomach conditions
• if you have clotting or blood disorders

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

• Anticoagulants (eg, warfarin, heparin) within the last 7 days, dipyridamole, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), ticlopidine, or thrombolytics (t-PA) because the risk of bleeding may be increased

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

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

• Abciximab is usually administered as an injection at your doctor’s office, hospital, or clinic. If you are using Abciximab at home, carefully follow the injection procedures taught to you by your health care provider.
• If Abciximab contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Abciximab, contact your doctor right away.

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

Important safety information:

• Abciximab may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Abciximab. Using Abciximab alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Abciximab may reduce the number of blood cells that are needed for clotting. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• LAB TESTS, including blood counts and blood clotting tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Abciximab is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Abciximab during pregnancy. It is unknown if Abciximab is excreted in breast milk. Do not breast-feed while taking Abciximab.

Possible side effects of Abciximab:

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:

Back pain; dizziness; general pain; headache; indigestion; nausea; pain at injection site; slow heart rate; stomach pain; swelling; vomiting.

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); abdominal pain or swelling; black or bloody stools; chest pain; chills; continued redness or pain after an injection; coughing up blood; excessive or unusual bleeding; fever; increased menstrual bleeding; nosebleeds; pink or red urine; severe headache; slow heartbeat; vomiting blood or material that looks like coffee grounds.

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 Abciximab:

Store Abciximab between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not shake. Discard any unused portion left in the vial. Keep Abciximab out of the reach of children and away from pets.

General information:

• If you have any questions about Abciximab, please talk with your doctor, pharmacist, or other health care provider.
• Abciximab 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 Abciximab. 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: Aripiprazole (AR-i-PIP-ra-zole)
Brand Name: Abilify

Abilify Solution is used for:

Treating schizophrenia, certain symptoms of bipolar disorder, and irritability associated with autistic disorder. It is also used along with other medicines to treat depression. It may also be used for other conditions as determined by your doctor.

Abilify Solution is an atypical antipsychotic. Exactly how it works is not known. It affects certain substances in the brain.

Do NOT use Abilify Solution if:

• you are allergic to any ingredient in Abilify Solution

Contact your doctor or health care provider right away if this applies to you.

Before using Abilify Solution:

Some medical conditions may interact with Abilify Solution. 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 history of heart problems (eg, heart failure, irregular heartbeat, heart attack), low blood pressure, blood vessel problems, or stroke
• if you have a history of low white blood cell levels, including low white blood cell levels caused by any medicine
• if you have a history of seizures, dementia, Alzheimer disease, depression or other mental or mood disorders, or suicidal thoughts or attempts
• if you have trouble swallowing or a history of neuroleptic malignant syndrome (NMS)
• if you are dehydrated, have low blood volume, or are taking medicine for high blood pressure
• if you or a family member has a history of diabetes or you are very overweight

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

• Anticholinergics (eg, benztropine, methscopolamine) because the risk of overheating may be increased
• Benzodiazepines (eg, lorazepam), clarithromycin, imidazole antifungals (eg, ketoconazole), quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or voriconazole because they may increase the risk of Abilify Solution’s side effects
• Carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Abilify Solution’s effectiveness
• Alpha-blockers (eg, terazosin) because the risk of their side effects may be increased by Abilify Solution

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

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

• Abilify Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Abilify Solution refilled.
• Take Abilify Solution by mouth with or without food.
• Taking Abilify Solution at the same time each day will help you remember to take it.
• Take Abilify Solution on a regular schedule to get the most benefit from it.
• Use the measuring cup that comes with Abilify Solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Continue to take Abilify Solution even if you feel well. Do not miss any doses.
• If you miss a dose of Abilify Solution, 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 Abilify Solution.

Important safety information:

• Abilify Solution may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Abilify Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are using Abilify Solution.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Abilify Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Abilify Solution may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Children, teenagers, and young adults who take Abilify Solution may be at increased risk for suicidal thoughts or actions. Watch all patients who take Abilify Solution closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or unusual changes in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Abilify Solution. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take Abilify Solution may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Abilify Solution in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Abilify Solution.
• Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
• Abilify Solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Abilify Solution may raise your blood sugar or increase your risk of developing diabetes. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Diabetes patients – Abilify Solution may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including fasting blood sugar levels and complete blood cell counts, may be performed while you use Abilify Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Abilify Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements or seizures.
• Abilify Solution should be used with extreme caution 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 Abilify Solution can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Abilify Solution while you are pregnant. It is not known if Abilify Solution is found in breast milk. Do not breast-feed while taking Abilify Solution.

Possible side effects of Abilify Solution:

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:

Abnormal dreams; blurred vision; constipation; dizziness; drowsiness; headache; increased appetite (in children); increased saliva production; lightheadedness; nausea; sore throat (in children); stomach upset; tiredness; trouble sleeping; vomiting; weight gain.

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); abnormal thinking; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; increased sweating; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (eg, chewing movements, puckering of mouth, puffing of cheeks); loss of control over urination; loss of coordination; muscle tremor, jerking, or stiffness; new or worsening mental or mood problems (eg, anxiety, depression, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still); one-sided weakness; seizures; severe or persistent restlessness; shortness of breath; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, urination, or appetite; unusual weakness); trouble swallowing; trouble walking; unusual bruising; unusual tiredness or weakness; vision or speech 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 aggression; confusion; fast, slow, or irregular heartbeat; loss of consciousness; seizures; severe drowsiness, dizziness, or vomiting; tremor; trouble breathing; unusual mental changes.

Proper storage of Abilify Solution:

Store Abilify Solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Throw away any unused medicine after the bottle has been open for 6 months. Throw away any unused medicine after the expiration date on the bottle has passed. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Abilify Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Abilify Solution, please talk with your doctor, pharmacist, or other health care provider.
• Abilify Solution 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 Abilify Solution. 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: Aripiprazole (AR-i-PIP-ra-zole)
Brand Name: Abilify Discmelt

Abilify Discmelt Orally Disintegrating Tablets are used for:

Treating schizophrenia, certain symptoms of bipolar disorder, and irritability associated with autistic disorder. It is also used along with other medicines to treat depression. It may also be used for other conditions as determined by your doctor.

Abilify Discmelt Orally Disintegrating Tablets are an atypical antipsychotic. Exactly how it works is not known. It affects certain substances in the brain.

Do NOT use Abilify Discmelt Orally Disintegrating Tablets if:

• you are allergic to any ingredient in Abilify Discmelt Orally Disintegrating Tablets

Contact your doctor or health care provider right away if this applies to you.

Before using Abilify Discmelt Orally Disintegrating Tablets:

Some medical conditions may interact with Abilify Discmelt Orally Disintegrating 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 history of heart problems (eg, heart failure, irregular heartbeat, heart attack), low blood pressure, blood vessel problems, or stroke
• if you have a history of low white blood cell levels, including low white blood cell levels caused by any medicine
• if you have a history of seizures, dementia, Alzheimer disease, depression or other mental or mood disorders, or suicidal thoughts or attempts
• if you have trouble swallowing or a history of neuroleptic malignant syndrome (NMS)
• if you are dehydrated, are taking medicine for high blood pressure, have low blood volume, or have a history of phenylketonuria
• if you or a family member has a history of diabetes or you are very overweight

Some MEDICINES MAY INTERACT with Abilify Discmelt Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticholinergics (eg, benztropine, methscopolamine) because the risk of overheating may be increased
• Benzodiazepines (eg, lorazepam), clarithromycin, imidazole antifungals (eg, ketoconazole), quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or voriconazole because they may increase the risk of Abilify Discmelt Orally Disintegrating Tablets’s side effects
• Carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Abilify Discmelt Orally Disintegrating Tablets’s effectiveness
• Alpha-blockers (eg, terazosin) because the risk of their side effects may be increased by Abilify Discmelt Orally Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Abilify Discmelt Orally Disintegrating 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 Abilify Discmelt Orally Disintegrating Tablets:

Use Abilify Discmelt Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Abilify Discmelt Orally Disintegrating Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Abilify Discmelt Orally Disintegrating Tablets refilled.
• Take Abilify Discmelt Orally Disintegrating Tablets by mouth with or without food.
• Taking Abilify Discmelt Orally Disintegrating Tablets at the same time each day will help you remember to take it.
• Take Abilify Discmelt Orally Disintegrating Tablets on a regular schedule to get the most benefit from it.
• Do not remove the tablet from the blister until you are ready to take a dose. To open the blister, peel back the foil to expose the tablet. Do not push the tablet through the blister. This could damage the tablet.
• Make sure your hands are dry before you handle the tablet. Do not break, crush, or chew the tablet. Place the entire tablet on your tongue and allow it to dissolve.
• It is recommended that Abilify Discmelt Orally Disintegrating Tablets be taken without liquid. However, it may be taken with liquid if needed.
• Continue to take Abilify Discmelt Orally Disintegrating Tablets even if you feel well. Do not miss any doses.
• If you miss a dose of Abilify Discmelt Orally Disintegrating Tablets, 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 Abilify Discmelt Orally Disintegrating Tablets.

Important safety information:

• Abilify Discmelt Orally Disintegrating Tablets may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Abilify Discmelt Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are using Abilify Discmelt Orally Disintegrating Tablets.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Abilify Discmelt Orally Disintegrating Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Abilify Discmelt Orally Disintegrating Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Children, teenagers, and young adults who take Abilify Discmelt Orally Disintegrating Tablets may be at increased risk for suicidal thoughts or actions. Watch all patients who take Abilify Discmelt Orally Disintegrating Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Abilify Discmelt Orally Disintegrating Tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take Abilify Discmelt Orally Disintegrating Tablets may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Abilify Discmelt Orally Disintegrating Tablets in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Abilify Discmelt Orally Disintegrating Tablets.
• Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
• Abilify Discmelt Orally Disintegrating Tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Abilify Discmelt Orally Disintegrating Tablets may raise your blood sugar or increase your risk of developing diabetes. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Diabetes patients – Abilify Discmelt Orally Disintegrating Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• This product contains phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
• Lab tests, including fasting blood sugar levels and complete blood cell counts, may be performed while you use Abilify Discmelt Orally Disintegrating Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Abilify Discmelt Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements or seizures.
• Abilify Discmelt Orally Disintegrating Tablets should be used with extreme caution 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 Abilify Discmelt Orally Disintegrating 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 Abilify Discmelt Orally Disintegrating Tablets while you are pregnant. It is not known if Abilify Discmelt Orally Disintegrating Tablets are found in breast milk. Do not breast-feed while taking Abilify Discmelt Orally Disintegrating Tablets.

Possible side effects of Abilify Discmelt Orally Disintegrating 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:

Abnormal dreams; blurred vision; constipation; dizziness; drowsiness; headache; increased appetite (in children); increased saliva production; lightheadedness; nausea; sore throat (in children); stomach upset; tiredness; trouble sleeping; vomiting; weight gain.

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); abnormal thinking; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; increased sweating; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (eg, chewing movements, puckering of mouth, puffing of cheeks); loss of control over urination; loss of coordination; muscle tremor, jerking, or stiffness; new or worsening mental or mood problems (eg, anxiety, depression, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still); one-sided weakness; seizures; severe or persistent restlessness; shortness of breath; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, urination, or appetite; unusual weakness); trouble swallowing; trouble walking; unusual bruising; unusual tiredness or weakness; vision or speech 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 aggression; confusion; fast, slow, or irregular heartbeat; loss of consciousness; seizures; severe drowsiness, dizziness, or vomiting; tremor; trouble breathing; unusual mental changes.

Proper storage of Abilify Discmelt Orally Disintegrating Tablets:

Store Abilify Discmelt Orally Disintegrating 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 Abilify Discmelt Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Abilify Discmelt Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Abilify Discmelt Orally Disintegrating 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 Abilify Discmelt Orally Disintegrating 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: Lidocaine/Benzalkonium (LYE-doe-kane/BEN-zal-KOE-nee-um)
Brand Name: Examples include A + D Cracked Skin Relief and Dr. Scholl’s Cracked Heel Relief

A + D Cracked Skin Relief Cream is used for:

Relieving pain and itching caused by minor cuts, scrapes, and burns. It may also be used as first aid treatment to help prevent skin infection.

A + D Cracked Skin Relief Cream is an antiseptic and anesthetic combination. It works by cleansing the wound. It also stops nerves from transmitting painful impulses to the brain.

Do NOT use A + D Cracked Skin Relief Cream if:

• you are allergic to any ingredient in A + D Cracked Skin Relief Cream or to similar medicines (eg, amide-type local anesthetics)
• you have signs of infection (eg, oozing, warmth, pain) or tissue damage in the affected area

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

Before using A + D Cracked Skin Relief Cream:

Some medical conditions may interact with A + D Cracked Skin Relief Cream. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any anesthetic medicine
• if you have heart, liver, or kidney problems; diabetes; or poor circulation
• if the affected area is an animal bite, a burn, or a deep wound (eg, puncture wound), or if there is redness or swelling in the affected area

Some MEDICINES MAY INTERACT with A + D Cracked Skin Relief Cream. Because little, if any, of A + D Cracked Skin Relief Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if A + D Cracked Skin Relief Cream 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 A + D Cracked Skin Relief Cream:

Use A + D Cracked Skin Relief Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands before and immediately after using A + D Cracked Skin Relief Cream, unless your hands are part of the treated area.
• Wash and completely dry the affected area. Apply a thin layer of A + D Cracked Skin Relief Cream to the affected area. Gently rub the medicine in until it is evenly distributed.
• If you miss a dose of A + D Cracked Skin Relief Cream, 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.

Ask your health care provider any questions you may have about how to use A + D Cracked Skin Relief Cream.

Important safety information:

• A + D Cracked Skin Relief Cream may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• A + D Cracked Skin Relief Cream is for external use only. Do not get it in your eyes or on the inside of your nose or mouth. If you get A + D Cracked Skin Relief Cream in your eyes, rinse them immediately with cool water.
• A + D Cracked Skin Relief Cream may cause a numbing effect at the application site. Do not scratch, rub, or expose the area to extreme hot or cold temperatures until the numbness is gone.
• Do not apply A + D Cracked Skin Relief Cream over large areas of the body, to open wounds, or to blistered or infected skin without first checking with your doctor.
• Do not use more often than recommended or use for longer than 7 days without checking with your doctor.
• If you symptoms do not get better within 7 days or if they get worse, check with your doctor.
• Talk with your doctor before you use any other medicines or cleansers on your skin.
• Different brands of A + D Cracked Skin Relief Cream may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give to a child, check with your doctor or pharmacist.
• PREGNANCY and BREAST-FEEDING: It is not known if A + D Cracked Skin Relief Cream can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using A + D Cracked Skin Relief Cream while you are pregnant. It is not known if A + D Cracked Skin Relief Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use A + D Cracked Skin Relief Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of A + D Cracked Skin Relief Cream:

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 redness or swelling at the application site.

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); excessive irritation; signs of infection in the affected area (eg, warmth, oozing, pain).

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. A + D Cracked Skin Relief Cream may be harmful if swallowed.

Proper storage of A + D Cracked Skin Relief Cream:

Store A + D Cracked Skin Relief Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Keep A + D Cracked Skin Relief Cream out of the reach of children and away from pets.

General information:

• If you have any questions about A + D Cracked Skin Relief Cream, please talk with your doctor, pharmacist, or other health care provider.
• A + D Cracked Skin Relief Cream 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.
• Discard unused medicine and packaging in the trash out of the reach of children and pets.

This information is a summary only. It does not contain all information about A + D Cracked Skin Relief Cream. 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.