Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Sulpiride
AS Grindeks
N05AL01
Sulpiride
Tablet
sulpiride
Not marketed
2022-09-23
PACKAGE LEAFLET: INFORMATION FOR THE USER SULPIRIDE GRINDEKS 50 MG TABLETS SULPIRIDE GRINDEKS 100 MG TABLETS SULPIRIDE GRINDEKS 200 MG TABLETS sulpiride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Sulpiride Grindeks is and what it is used for 2. What you need to know before you use Sulpiride Grindeks 3. How to use Sulpiride Grindeks 4. Possible side effects 5. How to store Sulpiride Grindeks 6. Contents of the pack and other information 1. WHAT SULPIRIDE GRINDEKS IS AND WHAT IT IS USED FOR Sulpiride Grindeks contains a medicine called sulpiride. This belongs to a group of medicines called ‘benzamides’. It works by blocking the effect of a chemical in the brain. Sulpiride Grindeks are used to treat schizophrenia. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SULPIRIDE GRINDEKS DO NOT USE SULPIRIDE GRINDEKS – If you are allergic to sulpiride or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. – If you have a tumour of the adrenal gland called 'phaeochromocytoma'. – If you have a rare illness called ‘porphyria’ which affects your metabolism. – If you have breast cancer or cancer in the pituitary gland. – If you are taking levodopa or ropinirole used for Parkinson’s disease (see section _Other _ _medicines and Sulpiride Grindeks _ below). Do not take this medicine if any of the above apply to you. If you are not sure, talk to your docto সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 27 September 2022 CRN009WHQ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sulpiride Grindeks 100 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg sulpiride. Excipient with known effect: Each 100 mg tablet contains 11.0 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Sulpiride Grindeks 100 mg are white or almost white round tablets with bevelled edges. Dimension of tablet: diameter approximately 7.0 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute and chronic schizophrenia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ A starting dose of 400 mg to 800 mg, given twice daily (morning and early evening) is recommended. Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses, and a starting dose of at least 400 mg twice daily is recommended, increasing if necessary up to a suggested maximum of 1200 mg twice daily. Increasing the dose beyond this level has not been shown to produce further improvement. Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy, as well as depression) respond to doses below 800 mg daily; therefore, a starting dose of 400 mg twice daily is recommended. Reducing this dose towards 200 mg twice daily will normally increase the alerting effect of Sulpiride Grindeks. Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of 400-600 mg twice daily. _ _ _Paediatric population_ Clinical experience in children under 14 years of age is insufficient to permit specific recommendations. _Elderly_ The same dose ranges may be required in the elderly, but should be reduced if there is evidence of renal impairment. Method of administration For oral use. The tablet should be swallowed whole with a sufficient amount of water. 4.3 CONTRAINDICATIONS - Hypersen সম্পূর্ণ নথি পড়ুন