When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to paliperidone or risperidone.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• A nurse or other health provider will give you this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

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 foods and medicines can affect how paliperidone works. Tell your doctor if you are using any of the following:
  
  • Carbamazepine, levodopa, paroxetine, rifampin, St John's wort
  • Antibiotic medicines (such as gatifloxacin, moxifloxacin)
  • Blood pressure medicines
  • Medicine for heart rhythm problems (such as amiodarone, quinidine, procainamide, sotalol)
  • Other medicine to treat mental illness (such as 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, diabetes, Parkinson disease, or a history of seizures or neuroleptic malignant syndrome. Tell your doctor if you have blood vessel or heart problems, low blood pressure, heart failure, heart rhythm problems, or a history of a heart attack or stroke.
• This medicine may cause the following:
  
  • Neuroleptic malignant syndrome (possibly life-threatening neurological disorder)
  • QT prolongation (heart rhythm problem)
  • Tardive dyskinesia (movements you cannot control)
  • High blood sugar levels or high cholesterol levels
  • Low blood pressure
• This medicine may cause dizziness, drowsiness, or loss of coordination. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may affect how your body regulates temperature. Use caution during exercise or other activities that may cause you to become too hot. Drink plenty of liquids to avoid dehydration.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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
• Change in how much or how often you urinate
• Chills, cough, runny or stuffy nose, sore throat, body aches
• Difficulty swallowing
• Fast, slow, pounding, or uneven heartbeat
• Fever, confusion, sweating, muscle stiffness
• Lightheadedness, dizziness, fainting
• Painful, prolonged erection of your penis
• Seizures
• Twitching or muscle movements you cannot control (often in your face, tongue, or jaw)
• Unusual bleeding, bruising, or weakness

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

• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Sleepiness or unusual drowsiness
• 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