This medicine contains paliperidone as active ingredient. It is an antipsychotic drug, belonging to the class of psychoactive medicines, that has a specific effect on certain neurotransmitters (dopamine en serotonin), the chemical messengers in the brain. Because antipsychotic drugs depress the action of dopamine and serotonin, they can disturb its balance with another chemical in the brain, acetylcholine. If that occurs, symptoms like those of parkinsonism can appear.
This medicine is prescribed for:
• Bipolar disorder
• Symptoms of Alzheimer’s disease
• Resistant depression
Before using this medicine
Before you use this medicine check with your doctor, or pharmacist:
• if you ever had any unusual or allergic reaction to this medicine or any psychoactive drug;
• if you are pregnant or intend to become pregnant while using this medicine;
• if you are breast-feeding an infant;
• if you have liver or kidney disease;
• if you have a heart problem;
• if you have a history of seizures (convulsions, epilepsy).
• This medication is used for treatment of severe mental, nervous and emotional conditions. The drug is known to help the management of signs and symptoms of schizophrenia, Alzheimer’s disease, bipolar disorders and resistant depression.
• Usual dosage: The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Starting dose for adults is 6 mg once a day. The daily dose may be increased gradually up to 12 mg a day if needed. The starting dosage for seniors is 0.5 mg twice a day. The medicine is not recommended for children.
• If you forget to take a dose of this medicine, take it as soon as you remember. The tablets should be swallowed with liquid. The oral solution should be diluted in 3 to 4 ounces of liquid (water or orange juice).
• Do not discontinue the use of this drug without consulting your doctor. Dosage may require a gradual reduction before stopping.
• For safe and effective use of medicine: Follow your doctor’s instructions if this medicine was prescribed; follow the manufacturer’s package directions if you are treating yourself.
Along with the needed effects, a medicine may cause some unwanted effects. Possible side effects include:
Confusion and irritability
Warnings and Cautions
• The medicine has been associated with increased mortality in seniors with dementia or Alzheimer’s disease. The specific causes of death related to atypical psychotic drugs were either due to a heart-related event or infection, mostly pneumonia.
• A series set of side effects known as neuroleptic malignant syndrome has been associated with some antipsychotic drugs. The symptoms that constitute neuroleptic malignant syndrome include:
• High fever
• Muscle rigidity
• Mental changes
• Irregular pulse
• Irregular blood pressure
• Abnormal heart rhythm.
Neuroleptic malignant syndrome is potentially fatal and requires immediate medical attention.
• The medicine can produce uncontrolled movements including:
• Spasm of neck muscles
• Rolling back of the eyes
• Difficulty swallowing
• Symptoms associated with Parkinson’s disease
These effects usually disappear after the drug has been discontinued. Face, tongue, and jaw symptoms may persist, especially in older women. Contact your doctor immediately if you experience any of these symptoms.
• This medication should not be given to people with:
• Severe narrowing of the gastrointestinal tract
• Small bowel inflammation
• Narrowing of the bowels
• Slowed gastrointestinal motility
• Past history of peritonitis
• Cystic fibrosis
• Because these drugs can have permanent as well as temporary side effects, the minimum necessary dosage is used. This is found by starting with a low dose and increasing it until symptoms are controlled. Sudden withdrawal of antipsychotics after more than a few weeks can cause nausea, vomiting, sweating, headache and restlessness. For this reason the dose is reduced gradually when the drug treatment needs to be stopped.
Driving and Hazardous Work
Do not drive until you learn how the medicine affects you. Do not work around dangerous machinery. Do not climb ladders or work in high places. Danger increases if you drink alcohol or take medicines affecting alertness and reflexes.
The following symptoms may be a sign of overdose:
Faintness or convulsions
Difficulty in breathing
Call a doctor or hospital emergency room for instructions. If necessary start first aid immediately.
The effect of this medicine may be reduced if it is taken together with carbamazepine. It may increase the effect of antihypertensives. Taken together with central nervous system depressants it may increase the sedative effect.
• Be sure to tell your doctor about any medications you are currently taking.
Tablets and oral solution should be stored at room temperature; store away from heat and direct light. Keep out of reach of children, since this medicine may be dangerous in children.