Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amisulpride
Necessity Supplies Ltd
N05AL05
Amisulpride
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100
SOLIAN ® 200 MG TABLETS SOLIAN ® 400 MG TABLETS (amisulpride) PATIENT INFORMATION LEAFLET 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 medicine is available using the above name but will be referred to as Solian throughout this leaflet. This medicine is also available in other strengths. IN THIS LEAFLET: 1. What Solian is and what it is used for 2. Before you take Solian 3. How to take Solian 4. Possible side effects 5. How to store Solian 6. Further Information 1. WHAT SOLIAN IS AND WHAT IT IS USED FOR Solian contains a medicine called 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. Solian works by improving disturbed thoughts, feelings and behaviour. It is used to treat schizophrenia when it starts and also over the long term. 2. BEFORE YOU TAKE SOLIAN DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: - You are allergic (hypersensitive) to amisulpride or any of the other ingredients of Solian (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue - You have breast cancer or something called ‘a prolactin dependent tumour’ - You have a tumour on the adrenal gland (called phaeochromocytoma) - You are taking levodopa, a medicine to treat Parkinson’s disease (see ‘Taking read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solian 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg of the active substance, amisulpride Also contains 139.2mg of lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White to off-white, round, flat-faced, breakable tablet engraved AMI 200 on one face and with a breakable bar on the other face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Solian 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 Solian. 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. Solian 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 r read_full_document