Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amisulpride
Sandoz Ltd
N05AL05
Amisulpride
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100
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 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 Amisulpride contains the active substance amisulpride. It belongs to a group of medicines called antipsychotics. Amisulpride is used to treat schizophrenia, when it starts and also over the long term. Symptoms of this illness include: • so called positive symptoms:- hallucinations, such as feeling, seeing or hearing things which do not exist - strange and/or frightening thoughts - changes in your behaviour, which can be aggressive • so called negative symptoms: - becoming withdrawn and subdued Do not take Amisulpride if you are/have • allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). • breast cancer or something called “prolactin-dependent tumour” • a tumour on the adrenal gland • a child before the onset of puberty • taking levodopa: a medicine to treat Parkinson’s disease Warnings and Precautions Talk to your doctor or pharmacist before taking Amisulpride if: • you are developing fever, faster breathing, excessive sweating, reduced consciousness or stiff muscles which are symptoms of a severe – potentially fatal – disorder called “neuroleptic malignant syndrome”. Stop immediately taking Amisulpride and contact your doctor. See also section 4, first paragraph • you have high blood sugar levels - diabetes mellitus - or are at risk of developing it If you do, your doctor may check your blood sugar levels while you are taking Amisulpride. • you have kidney function disorder See section “3 How to ta Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amisulpride 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of amisulpride _ _ Excipient with known effect Each tablet contains 95.00 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, flat, 11 mm in diameter, with a score line. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders with: - positive symptoms such as delusions, hallucinations, thought disorders, hostility, suspiciousness - negative symptoms (deficit syndrome) such as blunted affect, emotional and social withdrawal. This includes patients with predominant negative symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For acute psychotic episodes, oral doses between 400 mg/day and 800 mg/day are recommended. In individual cases, the daily dose may be increased up to 1200 mg. Doses above 1200 mg/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 in example between 400-800mg/day. Maintenance treatment should be established individually with the minimally effective dose. For patients characterised by predominant negative symptoms, oral doses between 50 mg/day and 300 mg/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 bid. The minimum effective dose and appropriate strength tablets should be used. Special populations _Elderly (over 65 years):_ The safety of amisulpride has been examined in a limited number of elderly patients. Amis Izlasiet visu dokumentu