Product Summary

This product requires a valid prescription for shipment, please note that AtYourDoorPharmacy.com may not accept prescriptions faxed or emailed by patients.

PRESCRIPTION REQUIRED

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. PALIPERIDONE EXTENDED-RELEASE - ORAL (PAL-ee-PER-i-done) COMMON BRAND NAME(S): Invega WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (e.g., stroke, heart failure) when this medication is used in elderly patients with dementia. This medication is not approved for the 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 the doctor. If you are using paliperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.

USES: This medication is used to treat certain mental/mood disorders (e.g., schizophrenia, schizoaffective disorder). Paliperidone is known as an anti-psychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals (neurotransmitters) in the brain. This medication can decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used in combination with other medication to treat depression.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking paliperidone and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with or without food, usually once a day in the morning or as directed by your doctor. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet with liquid, without crushing or chewing. Dosage is based on your medical condition and response to treatment. For older children, the maximum recommended dose is 6 to 12 milligrams a day, based on body weight. For adults, the maximum recommended dose is 12 milligrams a day. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Continue taking this medication exactly as prescribed, even if you are feeling better and thinking more clearly. Do not stop taking this medication without first consulting your doctor. Also, do not increase your dose or take this medication more often than prescribed. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, abdominal/stomach pain, weight gain, cough, or dry mouth may occur. If any of these side effects persist or worsen, tell your doctor promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. These side effects are more likely to occur in the first few days after starting/restarting the drug or after your dose increases. An empty tablet shell may appear in your stool. This is harmless. 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. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: difficulty swallowing, fast/slow/irregular heartbeat, restlessness, shaking (tremor), muscle spasms, pain/swelling/redness of arms or legs, signs of infection (such as fever, persistent sore throat). Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, fainting, chest pain. Paliperidone may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face, lips, mouth, tongue, arms, or legs). This drug may infrequently cause a serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome). Seek immediate medical attention if you notice any of the following rare but very serious

SIDE EFFECTS: muscle stiffness/pain, high fever, increased sweating, mental/mood changes, change in the amount of urine. Rarely, this medication may increase your blood level of a certain hormone (prolactin). In females, an increase in prolactin levels may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. In males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately. For males, in the very unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention, or permanent problems could occur. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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: Before taking paliperidone, tell your doctor or pharmacist if you are allergic to it; or to risperidone; 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: severe liver disease, kidney disease, esophagus/stomach/intestinal movement or blockage disorders (e.g., difficulty swallowing, diarrhea, peritonitis, cystic fibrosis, Meckel's diverticulum), a severe loss of body water (dehydration), disease of the blood vessels in the brain (e.g., stroke), seizures, breast cancer, Parkinson's disease, Alzheimer's disease, low white blood cell count. Also tell your doctor or pharmacist if you or a family member has a history of the following: alcohol/drug abuse, high blood cholesterol/triglyceride levels, heart disease (e.g., ischemic heart disease), blood pressure problems, diabetes, obesity. Paliperidone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using paliperidone, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using paliperidone safely. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar such as unusual increased thirst/urination or vision changes. If you already have diabetes, be sure to check your blood sugar level regularly. This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.) This drug can make you more likely to get heat stroke. Avoid activities that may cause you to overheat (e.g., strenuous work, exercising in hot weather, using hot tubs). Drink plenty of fluids, dress lightly, and stay in cool/air-conditioned areas when the weather is hot. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug. 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 and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Many drugs besides paliperidone may affect the heart rhythm (QT prolongation), including amiodarone, chlorpromazine, moxifloxacin, dofetilide, pimozide, quinidine, sotalol, procainamide, macrolide antibiotics (such as erythromycin), among others. Therefore, before using paliperidone, report all medications you are currently using to your doctor or pharmacist. This drug should not be used with the following medication because a very serious interaction may occur: sibutramine. If you are currently using the medication listed above, tell your doctor or pharmacist before starting paliperidone. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., belladonna alkaloids, benztropine, scopolamine), carbamazepine, certain medications for Parkinson's disease (levodopa, dopamine agonists such as bromocriptine), drugs for treating high blood pressure (e.g., alpha blockers such as prazosin, ACE inhibitors such as lisinopril), risperidone. Also report the use of drugs that might increase seizure risk when combined with paliperidone such as bupropion, isoniazid (INH), phenothiazines (e.g., thioridazine), tramadol, theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, nortriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local 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: severe drowsiness/dizziness, fast/irregular heartbeat, muscle stiffness/spasms, restlessness, unusual/uncontrolled movements.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., fasting blood sugar, kidney function, cholesterol/triglyceride levels, blood pressure, weight) should be performed regularly 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 at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product. Information last revised May 2012. Copyright(c) 2012 First Databank, Inc.

Paliperidone ER 6mg Tablet