Paliperidone

Paliperidone is used for:

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Treating schizophrenia. It may also be used for other conditions as determined by your doctor.

Paliperidone is an atypical antipsychotic. Exactly how it works is not known. It is thought to affect certain substances in the brain.

Do NOT use Paliperidone if:

• you are allergic to any ingredient in Paliperidone or to risperidone
• you have moderate to severe kidney problems or a history of certain heart problems (eg irregular heartbeat, long QT syndrome)
• you are taking certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol), a phenothiazine (eg, chlorpromazine, thioridazine), certain quinolones (eg, gatifloxacin, moxifloxacin), or tetrabenazine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Paliperidone :

Some medical conditions may interact with Paliperidone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of seizures, heart problems (eg, heart failure; fast, slow, or irregular heartbeat), abnormal electrocardiogram (ECG), heart attack, stroke, blood vessel problems, low white blood cell levels, or high or low blood pressure
• if you have a history of kidney problems, liver problems, stomach or bowel problems (eg, narrowing, inflammation, blockage), cystic fibrosis, neuroleptic malignant syndrome (NMS), suicidal thoughts or attempts, or alcohol abuse or dependence
• if you have diabetes or are very overweight, or if a family member has had diabetes
• if you have low blood potassium or magnesium levels, Alzheimer disease, dementia, Parkinson disease, diarrhea, or esophagus problems (eg, trouble swallowing)
• if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk for breast cancer
• if you are dehydrated, drink alcohol, or will be exposed to high temperatures

Some MEDICINES MAY INTERACT with Paliperidone . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Arsenic, antiarrhythmics, (eg, amiodarone, flecainide, procainamide, quinidine, sotalol), quinolones (eg, levofloxacin, moxifloxacin, gatifloxacin), cisapride, dofetilide, domperidone, H₁ antagonists (eg, astemizole, terfenadine), macrolides (eg, erythromycin), methadone, phenothiazines, (eg, chlorpromazine, thioridazine), streptogramins (eg, quinupristin/dalfopristin), tetrabenazine, or tyrosine kinase inhibitors (eg, nilotinib, sunitinib) because the risk of irregular heartbeat may be increased
• Alpha-blockers (eg, doxazosin) or medicine for high blood pressure because the risk of low blood pressure and fainting may be increased
• Anticholinergics (eg, scopolamine) because the risk of overheating may be increased
• Oral paliperidone or risperidone because they may increase the risk of Paliperidone 's side effects
• Carbamazepine because it may decrease Paliperidone 's effectiveness
• Dopamine receptor agonists (eg, pramipexole) or levodopa because their effectiveness may be decreased by Paliperidone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Paliperidone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Paliperidone :

Use Paliperidone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Paliperidone . Talk to your pharmacist if you have questions about this information.
• Paliperidone is given as an injection into the muscle at your doctor's office, hospital, or clinic.
• Drinking extra fluids while you are taking Paliperidone is recommended. Check with your doctor for instructions.
• If you miss a dose of Paliperidone , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Paliperidone .

Important safety information:

• Paliperidone may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Paliperidone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are using Paliperidone .
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Paliperidone ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Paliperidone may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Paliperidone may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• NMS is a possibly fatal syndrome that can be caused by Paliperidone . Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take Paliperidone may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Paliperidone in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Paliperidone .
• Tell your doctor or dentist that you take Paliperidone before you receive any medical or dental care, emergency care, or surgery.
• Paliperidone 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.
• Paliperidone may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
• Paliperidone may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
• Lab tests, including fasting blood sugar levels and complete blood cell counts, may be performed while you use Paliperidone . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Paliperidone with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscles movements.
• Paliperidone should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Paliperidone while you are pregnant. Paliperidone is found in breast milk. Do not breast-feed while you are using Paliperidone .

Possible side effects of Paliperidone :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth; headache; indigestion; lightheadedness; pain, swelling, or redness at the injection site; restlessness; sore throat; weakness; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; behavior changes; chest pain; confusion; decreased sexual ability; decreased urination; enlarged breasts; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; mental or mood changes; missed menstrual period; muscle pain, weakness, or stiffness; nipple discharge; prolonged, painful erection; seizures; severe or prolonged dizziness or headache; shortness of breath; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual eye movements.

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. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include fainting; fast or irregular heartbeat; loss of consciousness; seizures; severe drowsiness or dizziness; stiffness of the face, limbs, or neck; trouble walking; unusual muscle movement.

Paliperidone is usually handled and stored by a health care provider. If you are using Paliperidone at home, store Paliperidone as directed by your pharmacist or health care provider. Keep Paliperidone out of the reach of children and away from pets.

General information:

• If you have any questions about Paliperidone , please talk with your doctor, pharmacist, or other health care provider.
• Paliperidone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Paliperidone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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