Uses of Paliperidone Extended-Release Tablets:

• It is used to treat schizophrenia.
• It is used to treat schizoaffective disorder.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Paliperidone Extended-Release Tablets?

• If you have an allergy to paliperidone, risperidone, or any other part of this medicine (paliperidone extended-release tablets).
• If you are allergic to this medicine (paliperidone extended-release tablets); any part of this medicine (paliperidone extended-release tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have kidney disease.
• If you have ever had a long QT on ECG or other heartbeat that is not normal.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you have ever had any of these health problems: Cystic fibrosis; narrowing of the GI (gastrointestinal) tract or other GI problems like bowel block, small bowel disease, short gut syndrome, or slow-moving swallowing tube (esophagus) or bowel tract; peritonitis.

This is not a list of all drugs or health problems that interact with this medicine (paliperidone extended-release tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (paliperidone extended-release tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Paliperidone Extended-Release Tablets?

• Tell all of your health care providers that you take this medicine (paliperidone extended-release tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (paliperidone extended-release tablets) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.
• Check your blood sugar as you have been told by your doctor.
• Avoid drinking alcohol while taking this medicine (paliperidone extended-release tablets).
• Dizziness, sleepiness, and feeling less stable may happen with this medicine (paliperidone extended-release tablets). These may lead to falling, which can cause broken bones or other health problems.
• Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping this medicine (paliperidone extended-release tablets), but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
• Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these have been deadly. This medicine is not approved to treat mental problems caused by dementia.
• If you are 65 or older, use this medicine (paliperidone extended-release tablets) with care. You could have more side effects.
• This medicine may affect being able to get pregnant. This effect goes back to normal when the drug is stopped. If you have questions, talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• Taking this medicine (paliperidone extended-release tablets) in the third trimester of pregnancy may lead to uncontrolled muscle movements and withdrawal in the newborn.

How is this medicine (Paliperidone Extended-Release Tablets) best taken?

Use this medicine (paliperidone extended-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take with a full glass of water.
• Swallow whole. Do not chew, break, or crush.
• Keep taking this medicine (paliperidone extended-release tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• If you have trouble swallowing, talk with your doctor.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• It may take several weeks to see the full effects.
• Talk with your doctor before you use other drugs and natural products that slow your actions.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Very bad dizziness or passing out.
• Change in how you act.
• Mood changes.
• Shakiness, trouble moving around, or stiffness.
• Slow heartbeat.
• Trouble swallowing.
• Seizures.
• More saliva.
• Any unexplained bruising or bleeding.
• Not able to control eye movements.
• Not sweating during activities or in warm temperatures.
• Breast pain.
• Enlarged breasts, nipple discharge, not able to get or keep an erection (in males), or period (menstrual) changes (in females).
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
• A type of abnormal heartbeat (prolonged QT interval) can happen with this medicine (paliperidone extended-release tablets). Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

What are some other side effects of Paliperidone Extended-Release Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Weight gain.
• Constipation.
• Feeling dizzy, sleepy, tired, or weak.
• Anxiety.
• Upset stomach or throwing up.
• Nose or throat irritation.
• Restlessness.
• You may see the tablet shell in your stool. This is normal and not a cause for concern.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Paliperidone Extended-Release Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (paliperidone extended-release tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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