Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
AMISULPRIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
AMISULPRIDE
400 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Amisulpride Mylan 400mg film-coated Tablets Amisulpride 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. WHAT IS IN THIS LEAFLET: 1. What Amisulpride Mylan is and what it is used for 2. What you need to know before you take Amisulpride Mylan 3. How to take Amisulpride Mylan 4. Possible side effects 5. How to store Amisulpride Mylan 6. Contents of the pack and other information 1. WHAT AMISULPRIDE MYLAN IS AND WHAT IT IS USED FOR Amisulpride Mylan contains a medicine called amisulpride. This belongs to a group of medicines called ‘antipsychotics’. It is used in the treatment of acute and chronic schizophrenic disorders. This condition causes symptoms such as becoming withdrawn, sensing, seeing or hearing things which do not exist, mistaken beliefs or unfounded suspicions. Sometimes people with these symptoms may also feel tense, anxious or depressed. Amisulpride Mylan also acts on mood disorder in the sense of depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE MYLAN DO NOT TAKE AMISULPRIDE MYLAN - If you are allergic to amisulpride or any of the other ingredients ofthis medicine (listed in section 6) - if you notice signs of an allergic reaction including: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amisulpride Mylan 400 mg film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amisulpride Mylan contains 400 mg amisulpride per tablet. Excipient with known effect: 200 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white, 18 x 8 mm capsule shaped, film coated tablet with break line on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amisulpride Mylan is indicated for the treatment of acute and chronic schizophrenic disorders: • Positive symptoms with delusions, hallucinations, thought disorders, hostility and suspicious behavior. • Primarily negative symptoms (deficit syndrome) with blunted affect, emotional and social withdrawal. Amisulpride Mylan also controls secondary negative symptoms in productive conditions as well as affective disorders such as depressive mood or retardation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: For acute psychotic episodes the recommended oral dose ranges from 400 to 800 mg/day. 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 with Amisulpride Mylan. Doses should be adjusted according to individual response. Maintenance treatment should be established individually with the minimally effective dose. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. For patients characterized by predominant negative symptoms, oral doses between 50 mg/day and 300 mg/day are recommended. Lestu allt skjalið