This medicine is an atypical antipsychotic agent used to treat schizophrenia. It may also be used to treat other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. This medicine is given as an injection into the muscle at your doctor's office, hospital, or clinic. Be sure to keep all doctor appointments while using this medicine. If the medicine contains particles, is cloudy or discolored, or if the vial is cracked or damaged in any way, do not use it. DRINKING EXTRA FLUIDS while you are taking this medicine is recommended. Check with your doctor or nurse for instructions. This medicine is usually handled and stored by a health care provider. If you are using this medicine at home, STORE THIS MEDICINE as directed by your pharmacist or health care provider. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and pets. It may take some time before your symptoms improve. Do not change your dose or stop taking this medicine without checking with your doctor. Continue to use this medicine even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor immediately. If you think you are going to miss a dose of this medicine, call your health care provider as soon as you can.
WARNING: THIS MEDICINE IS AN ATYPICAL ANTIPSYCHOTIC. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. THIS MEDICINE IS NOT APPROVED TO TREAT MENTAL PROBLEMS CAUSED BY DEMENTIA. Discuss any questions or concerns with your doctor. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol), certain antipsychotic medicines (eg, chlorpromazine, thioridazine), asenapine, citalopram, metoclopramide, nilotinib, certain quinolone antibiotics (eg, gatifloxacin, moxifloxacin), tetrabenazine, or any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other prescription or nonprescription medicines (eg, used for allergies, cancer, depression or other mental or mood problems, heartburn, high blood pressure, immune system suppression, irregular heartbeat or other heart problems, malaria or other infections, narcotic or other substance abuse or dependence, nausea or vomiting, pain, Parkinson disease, seizures, sleep problems, Tourette syndrome), multivitamin products, or herbal or dietary supplements (eg, St. John's wort). Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with this medicine. Tell your doctor if you are taking oral paliperidone or risperidone, or any other antipsychotic medicine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of seizures; heart problems (eg, heart failure; fast, slow, or irregular heartbeat); abnormal electrocardiogram (ECG); heart attack; stroke; transient ischemic attack (TIA) or mini-stroke, blood vessel problems; low white blood cell levels; high blood cholesterol or triglyceride levels; high or low blood pressure; kidney problems; liver problems; stomach or bowel problems (eg, narrowing, inflammation, blockage); cystic fibrosis; aspiration (inhaling foreign matter into the airway or lungs), including aspiration pneumonia; neuroleptic malignant syndrome (NMS); tardive dyskinesia (TD) (abnormal movements of the tongue or face); suicidal thoughts or attempts; Reye syndrome; alcohol abuse or dependence; a condition that can cause dizziness or fainting; high blood sugar, diabetes, or a family history of diabetes; low blood potassium or magnesium levels; Alzheimer disease; dementia; Parkinson disease; diarrhea; esophagus problems (eg, trouble swallowing); high blood prolactin levels; certain types of cancer (eg, breast, pancreas, pituitary); allergies; pregnancy; or breast-feeding. Tell your doctor if you are at risk for breast cancer; are dehydrated; have low blood volume; drink alcohol; are very overweight; or if you will be exposed to high temperatures or exercise strenuously. Tell your doctor if you have never taken paliperidone or risperidone. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have moderate to severe kidney problems or a history of irregular heartbeat (eg, long QT syndrome, prolonged QT interval). Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; lightheadedness; mild pain, swelling, or redness at the injection site; mild stomach pain or discomfort; nausea; restlessness; trouble sleeping; vomiting; weakness; or weight gain. If they continue or are bothersome, check with your doctor. THIS MEDICINE MAY CAUSE WEIGHT GAIN. Your weight may need to be monitored while you take this medicine. THIS MEDICINE MAY LOWER THE ABILITY OF YOUR BODY TO FIGHT INFECTION. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. THIS MEDICINE MAY INCREASE THE AMOUNT OF A CERTAIN HORMONE (PROLACTIN) in your blood. Symptoms may include enlarged breasts in men, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thoughts; behavior changes; chest pain; confusion; decreased urination; fainting; fast, slow, or irregular heartbeat; increased saliva production or drooling; increased sweating; muscle cramps, pain, weakness, or stiffness; new or worsening mental or mood changes (eg, agitation, anxiety); one-sided weakness; prolonged, painful erection; seizures; severe or persistent constipation or stomach pain; severe or persistent dizziness, drowsiness, or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; tremor; trouble concentrating, speaking, or swallowing; trouble urinating or inability to control urination; trouble sitting still; trouble walking or standing; uncontrolled or involuntary muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising or bleeding; unusual eye movements; or vision problems (eg, blurred vision). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include fainting; fast or irregular heartbeat; severe drowsiness or dizziness; trouble walking, speaking, or swallowing; or unusual or uncontrolled muscle movement.
IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.