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.