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Brand Names: Invega

Generic Name: paliperidone (Pronunciation: pal ee PER i done)

• What is paliperidone (Invega)?
• What are the possible side effects of paliperidone (Invega)?
• What is the most important information I should know about paliperidone (Invega)?
• What should I discuss with my healthcare provider before taking paliperidone (Invega)?
• How should I take paliperidone (Invega)?
• What happens if I miss a dose (Invega)?
• What happens if I overdose (Invega)?
• What should I avoid while taking paliperidone (Invega)?
• What other drugs will affect paliperidone (Invega)?
• Where can I get more information?

What is paliperidone (Invega)?

Paliperidone is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Paliperidone is used to treat schizophrenia.

Paliperidone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of paliperidone (Invega)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using paliperidone and call your doctor at once if you have any of these serious side effects:

• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
• restless muscle movements in your eyes, tongue, jaw, or neck;
• tremor (uncontrolled shaking);
• trouble swallowing;
• sudden numbness or weakness, especially on one side of the body;
• sudden and severe headache, or problems with vision, speech, or balance;
• fever, chills, body aches, flu symptoms; or
• white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

• breast swelling or discharge;
• changes in menstrual periods;
• mild restlessness, drowsiness, or tremor;
• blurred vision;
• dizziness or headache;
• weight gain;
• nausea, dry mouth, upset stomach; or
• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about paliperidone (Invega)?

Paliperidone is not for use in psychotic conditions related to dementia. Paliperidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

While you are taking paliperidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking paliperidone.

Paliperidone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Before using paliperidone, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by paliperidone.

Avoid drinking alcohol. It can increase some of the side effects of paliperidone.

Stop using paliperidone and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.