Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amisulpride
Accord-UK Ltd
N05AL05
Amisulpride
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5012617015921
LOGO ACCORD AMISULPRIDE 50MG, 100MG, AND 200MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, PHARMACIST OR NURSE. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 Amisulpride tablets contain the active substance amisulpride which belong to a group of medicines called benzamide antipsychotics. These work by improving thoughts, feelings and/or behaviour when these are disturbed in certain medical conditions. Amisulpride tablets may be used in the treatment of acute (severe or sudden) and chronic (ongoing or long-term) schizophrenia, a condition where certain symptoms become very noticeable. These include feeling, hearing or seeing things that aren’t really there (hallucinations), having a strong false belief despite evidence against it (delusions), inability to think normally, and feeling emotional, disinterested or withdrawn. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE TABLETS DO NOT TAKE AMISULPRIDE TABLETS IF YOU: • are BREASTFEEDING • are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6) have a TUMOUR that depends on prolactin (a hormone produced by the pituitary gland) or BREAST CANCER • have PHAEOCHROMOCYTOMA (a tumour of the adrenal gland causing high blood pressure) Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AMISULPRIDE 200mg TABLETS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200.000mg Amisulpride. Excipient with known effect: Lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. White to off-white, round tablets with a break line, diameter 12.5mm and impressed “C” and “AM” on one face. 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 POSOLOGY For acute psychotic episodes, oral doses between 400 mg per day and 800 mg per day are recommended. In individual cases, the daily dose may be increased up to 1200 mg per day. Doses above 1200 mg per day 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 per day and 300 mg per day 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 twice daily. _Elderly _ Amisulpride should be used with particular caution because of a possible risk of hypotension or sedation. Amisulpride should be used with particular caution because of a possible risk of hypotension and sedation. Reduction in dosage may a Przeczytaj cały dokument