Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amisulpride
A A H Pharmaceuticals Ltd
N05AL05
Amisulpride
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5025903000976
Apotex Europe B.V. UK/H/2350/01-04/DC Amisulpride 50 mg, 100 mg, 200 mg and 400 mg tablets 1 PACKAGE LEAFLET: INFORMATION FOR THE USER AMISULPRIDE 50 MG TABLETS 100 MG TABLETS 200 MG TABLETS 400 MG FILM-COATED TABLETS Amisulpride 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 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 Amisulpride Tablets are and what they are used for 2. What you need to know before you take Amisulpride Tablets 3. How to take Amisulpride Tablets 4. Possible side effects 5. How to store Amisulpride Tablets 6. Contents of the pack and other information 1. WHAT AMISULPRIDE TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in this medicine is amisulpride. This belongs to a group of medicines called ‘anti-psychotics’. It is used to treat an illness called schizophrenia. Schizophrenia can make you feel, see or hear things which do not exist, have strange and frightening thoughts, change how you act, and make you feel alone. Sometimes people with these symptoms may also feel tense, anxious or depressed. Amisulpride works by improving disturbed thoughts, feelings and behaviour. It is used to treat schizophrenia when it starts and also over the long term. Apotex Europe B.V. UK/H/2350/01-04/DC Amisulpride 50 mg, 100 mg, 200 mg and 400 mg tablets 2 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE TABLETS DO NOT TAKE AMISULPRIDE TABLETS: • You are allergic (hypersensitive) to amisulpride or any of the other excipients of Amisulpride (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amisulpride 100mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg amisulpride. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white, round, flat-faced tablet, engraved AMI 100 on one side and a breakline on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. No specific titration is required when initiating the treatment with amisulpride. Doses should be adjusted according to individual response. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterised by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually. Amisulpride can be administered once daily at oral doses up to 300 mg, higher doses should be administered bid. The minimum effective dose should be used. Elderly: The safety of amisulpride has been examined in a limited number of elderly patients. Amisulpride should be used with particular caution because of a possible risk of hypotension and sedation. Reduction in dosage may also be required because of renal insufficiency. Children: The efficacy and safety of amisulpride from puberty to Aqra d-dokument sħiħ