Invega is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Invega is used to treat schizophrenia in adults and teenagers who are at least 12 years old.

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

Invega 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 psychosis.

While you are taking Invega, 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 this medicine.

Stop taking Invega and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, or feeling like you might pass out.

Before taking this medicine

You should not use Invega if you are allergic to paliperidone or risperidone (Risperdal).

Paliperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

High doses or long-term use of paliperidone can cause a serious movement disorder that may not be reversible. The longer you use Invega, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

To make sure Invega is safe for you, tell your doctor if you have ever had:

• heart problems, or a heart attack;

• long QT syndrome (in you or a family member);

• high or low blood pressure, or fainting spells;

• low white blood cell (WBC) counts;

• a serious neurologic disorder caused by taking an antipsychotic medicine;

• uncontrolled muscle movements in your face;

• a stomach or intestinal disorder;

• liver or kidney disease;

• seizures or epilepsy;

• an electrolyte imbalance (such as low potassium or magnesium levels in your blood);

• diabetes (paliperidone may raise your blood sugar); or

• breast cancer.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. However, you may have withdrawal symptoms or other problems if you stop using your medicine during pregnancy. If you get pregnant, tell your doctor right away. Do not stop using Invega without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of paliperidone on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take Invega exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take Invega with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your doctor will need to check your progress on a regular basis.

Store at room temperature away from moisture, heat, and light.

You should not use Invega if you are allergic to paliperidone or risperidone (Risperdal).

Paliperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

High doses or long-term use of paliperidone can cause a serious movement disorder that may not be reversible. The longer you use Invega, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

To make sure Invega is safe for you, tell your doctor if you have ever had:

• heart problems, or a heart attack;

• long QT syndrome (in you or a family member);

• high or low blood pressure, or fainting spells;

• low white blood cell (WBC) counts;

• a serious neurologic disorder caused by taking an antipsychotic medicine;

• uncontrolled muscle movements in your face;

• a stomach or intestinal disorder;

• liver or kidney disease;

• seizures or epilepsy;

• an electrolyte imbalance (such as low potassium or magnesium levels in your blood);

• diabetes (paliperidone may raise your blood sugar); or

• breast cancer.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. However, you may have withdrawal symptoms or other problems if you stop using your medicine during pregnancy. If you get pregnant, tell your doctor right away. Do not stop using Invega without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of paliperidone on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness, fast heartbeats, and fainting.

While you are taking Invega, you may be more sensitive to heat. Avoid getting too hot, 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.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

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

Stop taking Invega and call your doctor at once if you have any of these signs of a serious movement disorder:

• tremors or shaking in your arms or legs;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

• any new or unusual muscle movements you cannot control.

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• breast swelling (in women or men), nipple discharge;

• changes in menstrual periods;

• impotence, penis erection that is painful or lasts 4 hours or longer;

• weight gain;

• low white blood cell counts - fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing;

• high blood sugar - increased thirst, increased urination, hunger, fruity breath odor; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, fast or pounding heartbeats, fainting.

Common Invega side effects may include:

• drowsiness;

• anxiety;

• muscle stiffness, tremors or shaking;

• uncontrolled muscle movements, trouble with walking, balance, or speech;

• weight gain;

• upset stomach, constipation;

• fast heart rate; or

• stuffy nose, sore throat.

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.

Using Invega with other drugs that make you dizzy or lower your blood pressure can worsen these effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with paliperidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.