Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amisulpride
A A H Pharmaceuticals Ltd
N05AL05
Amisulpride
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5025903000990
13/02/2020 19:41 - VISTAlink folder 103826446 - Page 1/5 PATIENT INFORMATION LEAFLET AMISULPRIDE 50MG, 100MG, 200MG AND 400MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. • Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect. IN THIS LEAFLET: 1. What amisulpride is and what it is used for 2. Before you take amisulpride 3. How to take amisulpride 4. Possible side effects 5. How to store amisulpride 6. Further information 1. WHAT AMISULPRIDE IS AND WHAT IT IS USED FOR The name of your medicine is Amisulpride 50mg, 100mg, 200mg or 400mg Tablets (called amisulpride throughout this leaflet). This belongs to a group of medicines ‘anti- psychotics’. It is used to treat schizophrenia. HOW AMISULPRIDE WORKS 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. 2. BEFORE YOU TAKE AMISULPRIDE DO NOT TAKE AMISULPRIDE AND TELL YOUR DOCTOR IF: X You are allergic (hypersensitive) to amisulpride or any of the other ingredients of amisulpride (listed in Section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. X You are pregnant, might become pregnant or are breast-feeding (see ‘Pregnancy and breast-feeding’ section below). X You have bre Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amisulpride 400mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg amisulpride. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, film-coated oblong scored, engraved AMI 400. 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 the age of 18 years have not been established. Th Prečítajte si celý dokument