Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RISPERIDONE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
RISPERIDONE
60 Tablet Tablets; 20Tablet Tablets; 100 Tablet Tablets; 60 Tablet Tablets; 10 Tablet Tablets; 20 Tablet Tablets
TORRENT PHARMACEUTICAL LIMITED
RESPIDON TABLET _ _ Risperidone (1mg, 2mg, 3mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Respidon used for 2. How Respidon works 3. Before you use Respidon 4. How to use Respidon 5. While you are using it 6. Side effects 7. Storage and Disposal of Respidon 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT RESPIDON IS USED FOR It is used to treat psychotic conditions which affect the way you think, feel and/or act. These are associated with symptoms such as confusion, hallucinations (e.g. hearing, seeing or sensing things which are not there), delusions, unusual suspiciousness (paranoia), emotional and social withdrawal. People with the above mentioned conditions also feel depressed, guilty, anxious or tense. For both sudden and long-lasting disorders Risperidone may be used. Ask your doctor if you are still unsure why you have been prescribed this medicine. HOW RESPIDON WORKS Risperidone rebalances of certain natural substances in the brain (such as dopamine and serotonin) to improve thinking, mood, and behaviour. BEFORE YOU USE RESPIDON - _When you must not use it _ Do not take Respidon if you: • Are allergic to Risperidone or any of the ingredients. These allergic reactions include rash, itching, swollen face or lips, or shortness of breath. • Have bone-marrow depression. • Have phaeochromocytoma (tumor of the adrenal glands). It is not to be used for individual in coma that is caused by the medicine Central Nervous System depressants. _Pregnancy and lactation _ _ _ _ _ Do not take Respidon if you are pregnant, trying to get pregnant or think you may be pregnant. Only take Respidon during pregnancy if the benefit justifies the potential risk to the baby. Do not take Respidon if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start use it _ Before taking Risperidone tablets tell your doctor or pharmacist if you: • Are having an eye surgery. • Baca dokumen lengkap
_METHOD OF ADMINISTRATION_ Oral use: RESPIDON tablets should be swallowed with a drink of water, with or without food. They should not be chewed or crushed. CONTRAINDICATIONS: Risperidone is contraindicated in patients with a known hypersensitivity to RESPIDON or any other ingredients of the RESPIDON tablet. It is also contraindicated in patient with coma caused by CNS depressents, bone-marrow depression and avoided in phaeochromocytoma. WARNING AND PRECAUTION: HYPERGLYCEMIA AND DIABETES MELLITUS Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycaemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycaemia-related adverse events in patients treated with atypical antipsychotics are not available. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria; polyphagia, and weakness. Patients who develop symptoms of hyperglycaemia du Baca dokumen lengkap