Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
AS GRINDEKS Krustpils iela 53 Riga, LV-1057 , Latvia
N05AL01
SULPIRIDE 100 mg
TABLET
SULPIRIDE 100 mg
POM
PSYCHOLEPTICS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-05-13
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 Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sulpiride Grindeks 50 mg tablets Sulpiride Grindeks 100 mg tablets Sulpiride Grindeks 200 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg, 100 mg or 200 mg sulpiride. _ _ Excipient with known effect: Each 50 mg tablet contains 5.5 mg lactose (as monohydrate); Each 100 mg tablet contains 11.0 mg lactose (as monohydrate); Each 200 mg tablet contains 22.0 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Sulpiride Grindeks 50 mg are white or almost white round tablets with bevelled edges. Dimension of tablet: diameter approximately 6.0 mm. Sulpiride Grindeks 100 mg are white or almost white round tablets with bevelled edges. Dimension of tablet: diameter approximately 7.0 mm. Sulpiride Grindeks 200 mg are white or almost white round tablets with bevelled edges and single score line on one side. Dimension of tablet: diameter approximately 10.0 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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 Soma hati kamili