Paliperidone

Paliperidone is an antipsychotic medicine that treats schizophrenia in adults and teenagers who are at least 12 years old.

Paliperidone may also be used for other reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You can take paliperidone with or without food.

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

Your doctor will need to monitor your progress regularly.

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

Paliperidone is not approved for use in older adults who have dementia-related psychosis.

You should not use paliperidone 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 paliperidone, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

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 paliperidone 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.

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

Stop taking paliperidone and call your doctor immediately if you experience 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.

Paliperidone may cause serious side effects. Call your doctor right away 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, painful penis erection that 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 side effects of paliperidone 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.

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

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

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 paliperidone, 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 paliperidone 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.

Using paliperidone with other drugs that can make you dizzy or lower your blood pressure can make these effects worse. 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 together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Many drugs can affect 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.