Paliperidone (pal-ee-PER-i-done)

Treats schizophrenia and schizoaffective disorder.

Brand Name(s):

Invega

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it. Swallow the tablet with a liquid.
• If you take the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• Missed dose: Call your doctor or pharmacist for instructions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how paliperidone works. Tell your doctor if you are using any of the following:
  • Carbamazepine, divalproex sodium, levodopa, paroxetine
  • Antibiotic medicine (including gatifloxacin, moxifloxacin)
  • Blood pressure medicine
  • Medicine for heart rhythm problems (including amiodarone, procainamide, quinidine, sotalol)
  • Medicine for mental illness (including chlorpromazine, thioridazine)
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, stomach or bowel problems (including blockage), Parkinson disease, dementia, trouble swallowing, or a history of breast cancer, seizures, or neuroleptic malignant syndrome. Tell your doctor if you have blood vessel or heart problems, heart failure, heart rhythm problems, low blood pressure, or a history of a heart attack or stroke.
• This medicine may cause the following problems:
  • Increased risk of stroke
  • Neuroleptic malignant syndrome (a nerve disorder that could be life-threatening)
  • Heart rhythm problem (including QT prolongation)
  • Tardive dyskinesia (a muscle disorder that could become permanent)
  • High blood sugar or high cholesterol levels
  • Increased levels of prolactin hormone
  • Increased risk of seizures
• This medicine may make you dizzy or drowsy, or may cause trouble with thinking or controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. You may also feel lightheaded when suddenly getting up from a lying or sitting position, so stand up slowly.
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• This medicine may change how your body regulates temperature. Avoid activities that could cause you to become very cold, hot, or dehydrated.
• Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chills, cough, sore throat, body aches
• Difficulty swallowing (that can cause food or liquid to get into your lungs)
• Fast, slow, pounding, or uneven heartbeat
• Fever, confusion, sweating, muscle stiffness, loss of consciousness, troubled breathing
• Jerky muscle movements you cannot control (often in your face, tongue, or jaw)
• Lightheadedness, dizziness, fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Painful, prolonged erection of the penis, which lasts for more than 4 hours
• Sudden or severe headache, problems with vision, speech, or walking
• Tremors or seizures
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Mild headache
• Nausea, vomiting, stomach pain
• Sleepiness or unusual drowsiness
• Swelling of the breasts or unusual milk production
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088