Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Amisulpride
Sanofi-Aventis Ireland Limited T/A SANOFI
N05AL; N05AL05
Amisulpride
200 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Benzamides; amisulpride
Marketed
1998-07-27
SOLIAN 50MG TABLETS SOLIAN 100MG TABLETS SOLIAN 200MG TABLETS SOLIAN 400MG FILM-COATED TABLETS Amisulpride IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 4035600 FOR HELP 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 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. IN THIS LEAFLET: 1. What Solian is and what it is used for 2. What you need to know before you take Solian 3. How to take Solian 4. Possible side effects 5. How to store Solian 6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW 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 are pregnant or might become pregnant (see 'Pregnancy and breast-feeding section) × You have breast cancer or something called ‘a prolactin dependent tumour’ × You have a pituitary tumour × You have a tumour on the adr Prečítajte si celý dokument
Health Products Regulatory Authority 25 August 2022 CRN00CQGT Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solian 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amisulpride 200 mg per tablet. Also contains lactose monohydrate 139.2mg per tablet. 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. The scoreline / breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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. Amisulpride also regulates secondary negative symptoms in productive state, as well as affective disorders such as depressive mood. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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/day. 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. Doses should be adjusted according to individual response. For patients with mixed positive and negative symptoms (deficit syndrome), 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/day and 300 mg/day are recommended. Doses should be adjusted individually. Amisulpride can be administered once a day at oral doses up to 400mg, higher d Prečítajte si celý dokument