When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to paliperidone or risperidone.

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.
• You may take this medicine with or without food.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it. Swallow the tablet with a liquid, such as water or juice.
• 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.

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

• Make sure your doctor knows if you are using medicines for heart rhythm problems (such as amiodarone, procainamide, quinidine, sotalol, Betapace®, Cordarone®, or Procanbid®) or a diuretic or a "water pill" (such as furosemide, hydrochlorothiazide [HCTZ], Aldactazide®, Aldactone®, Lasix®, or Maxzide®).
• Tell your doctor if you are using carbamazepine (Tegretol®), divalproex sodium (Depakote®), levodopa (Dopar®, Larodopa®), any medicine for mental illness (such as chlorpromazine, thioridazine, Mellaril®, or Thorazine®), or certain antibiotic medicines (such as gatifloxacin, moxifloxacin, Avelox®, or Tequin®).
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, breast cancer, brain tumor, high cholesterol in the blood, stomach or bowel blockage, Reye's syndrome, Parkinson's disease, trouble with swallowing, or a history of seizures or neuroleptic malignant syndrome (NMS). Tell your doctor if you have any kind of blood vessel or heart problems, including low blood pressure, heart failure, a low amount of blood, heart rhythm problems (such as QT prolongation), or a history of a heart attack or stroke. Also tell your doctor if you have ever had thoughts of hurting yourself.
• This medicine may cause an increase in your blood sugar. If you or your child have diabetes, you may need to check your blood sugar more often. If you are using a medicine for diabetes, your doctor may need to change your dose.
• This medicine is not approved to treat behavior disorders in older people who have dementia. Using this medicine to treat this problem could increase the risk of death. This risk has not been shown for the approved uses of this medicine.
• Some side effects are more likely to happen in elderly people who have memory problems or other reduced mental skills. Make sure the doctor knows if the person who will be using this medicine has forgetfulness or confusion related to aging (such as Alzheimer's disease or dementia).
• Stop taking this medicine and check with your doctor right away if you or your child have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
• Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using this medicine. Check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
• This medicine may make you dizzy, lightheaded, or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. Change positions slowly when getting up from a sitting or lying position.
• 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 cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.
• This medicine might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you or your child are too hot and cannot cool down.
• This medicine may increase your weight. Your doctor may need to check your or your child's weight regularly during treatment with this medicine.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Blood tests may be needed to check for any unwanted effects.
• Call your doctor if your symptoms do not improve or if they get worse.

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, sore throat, and body aches.
• Dry mouth, increased thirst, muscle cramps, nausea, or vomiting.
• Fast, slow, pounding, or uneven heartbeat.
• Fever, confusion, sweating, or muscle stiffness.
• Lightheadedness, dizziness, or fainting.
• Mood or behavioral changes, or thoughts of hurting yourself or others.
• Neck muscle spasm, throat tightness, difficulty with swallowing or breathing, or sticking out of the tongue.
• Painful, prolonged erection of your penis (in males).
• Pinpoint red spots on your skin.
• Problems with balance or walking.
• Seizures or tremors.
• Swelling of the breasts or unusual milk production.
• Trouble with speaking or swallowing.
• 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:

• Anxiety or restlessness.
• Drooling.
• Headache.
• Sleepiness or unusual drowsiness.
• Stomach pain or upset stomach.
• Unusual tiredness or weakness.
• 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