What PALIPRA is and what it is used for

• PALIPRA contains the active substance paliperidone which belongs to the class of antipsychotic medicines.
• PALIPRA is used to treat schizophrenia in adults and adolescents aged 15 years and older.
• Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and behavior and emotional flatness. People with this disorder may also feel depressed, anxious, guilty, or tense.
• PALIPRA is also used to treat schizoaffective disorder in adults.
• Schizoaffective disorder is a mental condition in which a person experiences a combination of schizophrenia symptoms (as listed above) in addition to mood disorder symptoms (feeling very high, feeling sad, feeling agitated, distracted, sleeplessness, talkativeness, losing interest in everyday activities, sleeping too much or too little, eating too much or too little, and recurrent thoughts of suicide).
• PALIPRA can help alleviate the symptoms of your disease and stop your symptoms from coming back.

Do not take PALIPRA

• If you are allergic to paliperidone, risperidone, or any of the other ingredients of this medicine.

Warnings and precautions

• Talk to your doctor, pharmacist or nurse before taking PALIPRA.
• Patients with schizoaffective disorder treated with this medicine should be carefully monitored for a potential switch from manic to depressive symptoms.
• This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death. (see section 4, possible side effects).
• If you have Parkinson’s disease or Dementia.
• If you have ever been diagnosed with a condition whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome).
• If you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia). You should be aware that both of these conditions may be caused by this type of medicine.
• If you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
• If you are diabetic or prone to diabetes.
• If you have heart disease or heart disease treatment that makes you prone to low blood pressure.
• If you have epilepsy.
• If you have a swallowing, stomach, or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
• If you have diseases associated with diarrhea.
• If you have kidney problems.
• If you have liver problems.
• If you have prolonged and/or painful erection.
• If you have difficulty controlling core body temperature or overheating.
• If you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin dependent tumor.
• If you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.

How and when to take PALIPRA

• This medicine must be taken by mouth and swallowed whole with water or other liquids. It must not be chewed, broken, or crushed.
• This medicine should be taken every morning with breakfast or without breakfast, but in the same way every day. Do not alternate between taking this medicine with breakfast one day and without having breakfast the next day.
• The active ingredient, paliperidone, dissolves once swallowed, and the tablet shell is passed out of the body as waste.

How to store PALIPRA

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Store in the original package in order to protect it from moisture.

What PALIPRA looks like and contents of the pack

• Palipra 3mg prolonged-release tablets
• White to off-white capsuleshaped tablets imprinted with "3 mg" on one side.
• Palipra 6mg prolonged-release tablets
• Beige capsule-shaped tablets imprinted with "6 mg" on one side.