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 risperidone or paliperidone.

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. This medicine is usually given every 2 weeks.
• 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 risperidone works. Tell your doctor if you are using carbamazepine, cimetidine, clozapine, fluoxetine, levodopa, paroxetine, phenobarbital, phenytoin, quinidine, ranitidine, rifampin, valproate, or blood pressure 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. Do not become pregnant or breastfeed during treatment and for at least 12 weeks after you stop using this medicine.
• Tell your doctor if you have kidney disease, liver disease, diabetes, high cholesterol, Parkinson disease, trouble swallowing, or a history of breast cancer or seizures. Tell your doctor if you have heart failure, 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)
  • Tardive dyskinesia (a muscle disorder that could become permanent)
  • High blood sugar or high cholesterol levels
  • Increased levels of prolactin hormone
  • Low blood pressure
• This medicine may make you drowsy or dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may change how your body regulates temperature. Avoid activities that could cause you to become very cold, hot, or dehydrated.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• 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
• Fast, slow, pounding, or uneven heartbeat
• Fever, sweating, confusion, or muscle stiffness
• Increased hunger or thirst, change in how much or how often you urinate
• Jerky muscle movements you cannot control (often in your face, tongue, or jaw)
• Lightheadedness, dizziness, or fainting
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Painful, prolonged erection of the penis
• Seizures or tremors
• Swelling of the breasts, breast soreness, nipple discharge (in both women and men)
• Trouble swallowing
• Unusual bleeding, bruising, or weakness

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

• Constipation, decreased appetite, vomiting, or stomach pain
• Drowsiness or headache
• Fever, chills, cough, sore throat, stuffy or runny nose, body aches
• Pain, swelling, or a lump under your skin where the shot is given
• 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