Paliperidone is an antipsychotic medicine that is used to treat schizophrenia in adults and teenagers who are at least 12 years old.

Paliperidone may also be used for purposes not listed in this medication guide.

Paliperidone is not approved for use in older adults with dementia-related psychosis.

Paliperidone comes as an extended-release (long-acting) tablet to take by mouth. It is usually taken once a day in the morning with or without food. Take paliperidone at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take paliperidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with plenty of water or other liquid. Do not split, chew, or crush the tablets. Tell your doctor if you cannot swallow tablets. Your doctor will probably prescribe another medication to treat your condition.

Talk to your doctor about how you are feeling during your treatment. If your symptoms are still bothersome, your doctor may gradually increase your dose, not more often than once every 5 days.

Paliperidone controls the symptoms of schizophrenia but does not cure the condition. Continue to take paliperidone even if you feel well. Do not stop taking paliperidone without talking to your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take paliperidone with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your doctor will need to check your progress on a regular basis.

Store at room temperature away from moisture, heat, and light.

You should not use paliperidone if you are allergic to paliperidone or risperidone (Risperdal).

Paliperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

High doses or long-term use of paliperidone can cause a serious movement disorder that may not be reversible. The longer you use paliperidone, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Tell your doctor if you have ever had:

• heart problems, or a heart attack;

• long QT syndrome (in you or a family member);

• high or low blood pressure, or fainting spells;

• low white blood cell (WBC) counts;

• a serious neurologic disorder caused by taking an antipsychotic medicine;

• uncontrolled muscle movements in your face;

• a stomach or intestinal disorder;

• liver or kidney disease;

• seizures or epilepsy;

• an electrolyte imbalance (such as low potassium or magnesium levels in your blood);

• diabetes (paliperidone may raise your blood sugar); or

• breast cancer.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. However, you may have withdrawal symptoms or other problems if you stop using your medicine during pregnancy. If you get pregnant, tell your doctor right away. Do not stop using paliperidone without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of paliperidone on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness, fast heartbeats, and fainting.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

While you are taking paliperidone, you may be more sensitive to heat. Avoid getting too hot, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking paliperidone.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how paliperidone will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking paliperidone and call your doctor at once if you have any of these signs of a serious movement disorder:

• tremors or shaking in your arms or legs;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

• any new or unusual muscle movements you cannot control.

Paliperidone may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• breast swelling (in women or men), nipple discharge;

• changes in menstrual periods;

• impotence, penis erection that is painful or lasts 4 hours or longer;

• weight gain;

• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing;

• high blood sugar--increased thirst, increased urination, hunger, fruity breath odor; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, fast or pounding heartbeats, fainting.

Common side effects of paliperidone may include:

• drowsiness;

• anxiety;

• muscle stiffness, tremors or shaking;

• uncontrolled muscle movements, trouble with walking, balance, or speech;

• weight gain;

• upset stomach, constipation;

• fast heart rate; or

• stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using paliperidone with other drugs that make you dizzy or lower your blood pressure can worsen these effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect paliperidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

You may notice something that looks like a tablet in your stool. This is just the empty tablet shell and does not mean that you did not get your complete dose of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.