What is the most important information I should know about paliperidone?
Paliperidone is not approved for use in psychotic conditions related to dementia. Paliperidone may increase the risk of death in older adults with dementia-related conditions.
What is paliperidone?
Paliperidone is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.
Paliperidone is used to treat schizophrenia in adults and teenagers who are at least 12 years old.
Paliperidone may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking paliperidone?
You should not use this medicine if you are allergic to paliperidone or risperidone (Risperdal).
Paliperidone is not approved for use in psychotic conditions related to dementia. Paliperidone may increase the risk of death in older adults with dementia-related conditions.
Paliperidone can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you use paliperidone, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.
To make sure paliperidone is safe for you, tell your doctor if you have ever had:
- heart disease, heart attack, heart rhythm disorder, long QT syndrome;
- high or low blood pressure, or fainting spells;
- low white blood cell (WBC) counts;
- a stomach or intestinal disorder;
- liver or kidney disease;
- seizures or epilepsy;
- breast cancer;
- suicidal thoughts;
- an electrolyte imbalance (such as low potassium or magnesium levels in your blood);
- diabetes (paliperidone may raise your blood sugar); or
- a serious neurologic disorder caused by taking an antipsychotic medicine.
Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking paliperidone, do not stop taking it without your doctor's advice.
Paliperidone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Older adults may be more sensitive to the effects of this medicine.
How should I take paliperidone?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Paliperidone can be taken with or without food.
Do not crush, chew, or break an extended-release tablet. Swallow it whole.
Use paliperidone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Your doctor will need to check your progress while you are using paliperidone.
Store at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include a headache with chest pain, fast or pounding heartbeats, and severe dizziness.
What should I avoid while taking paliperidone?
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.
Avoid drinking alcohol. Dangerous side effects could occur.
This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.
What are the possible side effects of paliperidone?
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking paliperidone 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:
- a light-headed feeling, like you might pass out;
- thoughts about suicide or hurting yourself;
- 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 --sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, swollen gums, pain when swallowing, skin sores, 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 may include:
- drowsiness;
- anxiety, feeling restless;
- tremors or shaking;
- uncontrolled muscle movements, problems with balance or walking;
- neck stiffness;
- weight gain; or
- fast heart rate.
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 other drugs will affect paliperidone?
Taking this medicine with other drugs that make you dizzy or lower your blood pressure can worsen these effects. Ask your doctor before taking a sleeping pill, opioid pain medicine, a muscle relaxer, or medicine for anxiety, depression, 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 in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about paliperidone.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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