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WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as heart failure, pneumonia, stroke) when this medication is used by older adults with dementia. This medication is not approved for treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with your doctor. If you are using aripiprazole in combination with other medication to treat depression, also carefully read the drug information for the other medication.

USES: Aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, and irritability associated with autistic disorder). It may also be used in combination with other medication to treat depression. Aripiprazole is known as an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters). This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. Aripiprazole can treat severe mood swings and decrease how often mood swings occur.

HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking aripiprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/cup. Do not use a household spoon because you may not get the correct dose. If you are using the rapidly dissolving tablets, dry your hands before peeling back the foil on the blister pack to carefully remove a tablet. Do not push the tablet through the foil. The tablet is fragile and is not intended to be cut, split, or broken. Place each dose on the tongue, allow it to dissolve completely, then swallow it with saliva. Do not remove the tablet from the blister pack until just before taking. You do not need to take this medication with water. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. It may take several weeks to get the full benefit of this drug. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may worsen when this drug is suddenly stopped. Your dose may need to be gradually decreased. Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: See also Warning section. Dizziness, lightheadedness, drowsiness, nausea, vomiting, tiredness, excess saliva/drooling, blurred vision, weight gain, constipation, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.www.chemswhite.com Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: fast/pounding heartbeat, fainting, mental/mood changes (such as increased anxiety, depression, suicidal thoughts), trouble swallowing, restlessness, shaking (tremor), muscle spasm/stiffness, mask-like expression of the face, seizures, signs of infection (such as fever, persistent sore throat). This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Rarely, very serious conditions such as diabetic coma may occur. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet. This medication may rarely cause a condition called tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms or legs). This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you develop the following: fever, muscle stiffness, severe confusion, sweating, fast/irregular heartbeat. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning and Side Effects sections. Before taking aripiprazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems with blood flow in the brain (such as cerebrovascular disease, stroke), diabetes (including family history), heart problems (such as low blood pressure, coronary artery disease, heart failure, irregular heartbeat), nervous system problems (such as dementia, NMS, seizures), obesity, low white blood cell count. This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages. This medication can make you more likely to get heat stroke, a very serious condition. Avoid activities that might cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). When the weather is hot, drink plenty of fluids and dress lightly. If you become overheated, promptly seek cooler shelter and stop exercising. Liquid preparations of this product may contain sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about using this product safely. The rapidly dissolving tablets may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely. Older adults may be more sensitive to the side effects of this drug, especially seizures, swallowing problems, and other serious (rarely fatal) side effects. (See also Warning section.) Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away. This medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Some products that may interact with this drug include: metoclopramide, sibutramine. Other medications can affect the removal of aripiprazole from your body, which may affect how aripiprazole works. Examples include azole antifungals (such as ketoconazole, itraconazole), quinidine, drugs for seizures (such as carbamazepine), SSRI antidepressants (such as fluoxetine, paroxetine), among others. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very fast heartbeat, loss of consciousness.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as blood sugar, weight) may be performed before and while you are taking this medication to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the tablets and the oral liquid at room temperature away from light and moisture. Discard the oral solution 6 months after opening or after the expiration date, whichever comes first. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.