Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SULPIRIDE
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
SULPIRIDE
500 Tablet Tablets; 500 Tablets
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 NEGATIL TABLET Sulpiride (50mg, 200mg) WHAT IS IN THIS LEAFLET 1. What Negatil Tablet is used for 2. How Negatil Tablet works 3. Before you use Negatil Tablet 4. How to use Negatil Tablet 5. While you are using it 6. Side Effects 7. Storage and Disposal of Negatil Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT NEGATIL TABLET IS USED FOR It is indicated for the treatment of schizophrenia (a severe brain disorder in which people interprets reality abnormally) and also chronic delusional psychoses (a brain disorder which results in confusion and misinterpretations of reality). HOW NEGATIL TABLET WORKS Sulpiride is the active ingredient of Negatil Tablet. Sulpiride belongs to a group of medicines call benzamide. It works by blocking effect of a natural chemical in the brain known to be involved in regulating mood and behavior, amongst other things. BEFORE YOU USE NEGATIL TABLET - _When you must not use it _ If you have: pre-existing central nervous system depression (suppression of brain activity that can result in decreased rate of breathing, heart rate, and loss of consciousness) or coma, bone-marrow suppression or phaeochromocytoma (tumor on the adrenal gland), severe liver, kidney or blood disease and breast-feeding. hypersensitivity (allergic) to sulpiride or its ingredient. - _Before you start to use it _ You must tell your doctor if: You have allergies to any medicine which you have taken previously to treat your current condition. You are pregnant, trying to become pregnant or breast- feeding. If you have impaired liver, kidney, cardiovascular (heart and blood vessels), cerebrovascular (brain and its blood vessels) and respiratory (breathing) function. If you have the following conditions: closed-angle glaucoma (eye condition caused by too much fluid pressure inside the eye), parkinsonism (progressive disorder of the nervous system that affects movement), di Přečtěte si celý dokument
7097-07 NEGATIL TABLET 50MG NEGATIL TABLET 200MG NAME AND STRENGTH OF ACTIVE INGREDIENT(S): NEGATIL TABLET 50MG Each tablet contains: Sulpiride …………………………………………………50mg NEGATIL TABLET 200MG Each tablet contains: Sulpiride…………………………………………………200mg PRODUCT DESCRIPTION: NEGATIL TABLET 50MG A yellow, round, scored of diameter 7mm flat tablet with ‘MPI’ marking. NEGATIL TABLET 200MG An orange, round, scored of diameter 9mm convex tablet with ‘MPI’ marking. PHARMACODYNAMICS : Sulpiride is a substituted benzamide which is claimed to exert its antipsychotic action via a selective blockage of central dopamine D2 receptors. PHARMACOKINETICS: Sulpiride is absorbed from the gastro-intestinal tract although bioavailability is low and subject to interindividual variation. It is rapidly distributed to the tissues but passage across the blood brain barrier is poor. Sulpiride is less than 40% bound to plasma proteins and is reported to have plasma half-life of about 7 to 9 hours. It is excreted in the urine chiefly as unchanged drug. INDICATION: Sulpiride is indicated for the treatment of schizophrenia and also chronic delusional psychoses. RECOMMENDED DOSAGE: Adult: Initial doses of 200-400mg twice daily, increased if necessary up to a maximum of 1-2g twice daily. Doses at the lower end of the range have a greater alerting effect and have been recommended for patients with predominant negative symptoms. Children: 3-5mg per kg body-weight. Children under 14 years not recommended. Elderly: Initiallly quarter to half adult dose. ROUTE OF ADMINISTRATION: Oral CONTRAINDICATIONS: Contraindicated in patients with pre-existing central nervous system depression or coma, bone-marrow suppression, or phaeochromocytoma, severe hepatic, renal or blood disease and breast-feeding. WARNINGS AND PRECAUTIONS: 1. It may cause sedative effects and is most marked during the first few days of adminstration; affected patients should not drive or operate machinery. 2. Caut Přečtěte si celý dokument