Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMISULPRIDE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
AMISULPRIDE
30Tablet Tablets
DELPHARM DIJON
_ _ _1 _ _ _ _ _ _ Consumer Medication Information Leaflet (RiMUP) _ SOLIAN ® TABLET _ _ Amisulpride (100mg, 400mg) _ _ WHAT IS IN THIS LEAFLET 1. What Solian is used for 2. How Solian works 3. Before you use Solian 4. How to use Solian 5. While you are using it 6. Side effects 7. Storage and Disposal of Solian 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SOLIAN IS USED FOR Solian contains a medicine called amisulpride. This belongs to a group of medicines called ‘antipsychotics’. This medicine is used to treat people with schizophrenia. Schizophrenia is a mental illness characterized by various mental and behavioral disorders, such as hallucinations or agitation. HOW SOLIAN WORKS Solian works by improving disturbed thoughts, feelings and behaviour. It is used to treat schizophrenia when it starts and also over the long term. BEFORE YOU USE SOLIAN _-When you must not use it _ Do not take Solian: if you are allergic to the active substance (amisulpride) or any of the other ingredients of this medicine. This is because this medicine may have an effect on your blood cells, i.e. reduce the number of white blood cells. This problem can be seen in a blood test, if you have a pheo _chromocytoma_ (excessive growth of the adrenal glands around the kidneys, releasing substances which cause high blood pressure), in children under 15 years of age, if you have a prolactin-dependent tumor (prolactin is a hormone that stimulates milk production), e.g. breast cancer or pituitary disorders, if you are taking other medicines. If this is the case, make sure that combined use with Solian is not contraindicated. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Solian. _-Before you start to use it _ Talk to your doctor or pharmacist before taking Solian. Your doctor may ask you to have an electrocardiogram (ECG) before starting treatment. This medicine can cause heart rhythm disor Διαβάστε το πλήρες έγγραφο
Page 1 of 11 QUALITATIVE AND QUANTITATIVE COMPOSITION Solian ® 100 mg, scored tablets Amisulpride …….……………………………1 00 mg Solian ® 400 mg, scored film -coated tablets Amisulpride ………………………………… 4 00 mg PHARMACEUTICAL FORM Solian ® 100 mg, scored tablets White to off -white sco red tablet, engraved “AMI 100” . Solian ® 400 mg, scored film -coated tablets White scored film -coated tablet, engraved “AMI 400”. CLINICAL PARTICULARS Therapeutic indications Treatment of acute or chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted emotions , emotional and social withdrawal) are pronounced , including patients with predominantly negative symptoms. Posology and method of administration Usu ally : - if the daily dose is ≤ 400 mg, it is to be administered as a once -daily dose ; - if the daily dose exceeds 400 mg, it is to be administered as two divided doses. Predominantly negative episodes: Doses between 50 mg/day and 300 mg/day are recommended. Doses should be adjusted individually. The optimum dosage is about 100 mg/day. Acute psychotic episodes It is possible to start via the IM route for a few days, at a maximum dose of 400 mg/day, switching thereafter to oral treatment, Oral doses between 400mg/day and 800mg/day are recommended. The maximum dose should never exceed 1200mg. Given that there has been no large -scale safety assessment of doses higher than 1200mg/day, these doses should not be used. The dosage should be maintained or adjusted according to the patient's individual response. In all cases, the maintenance treatment should be established individually with the minimum effective dose. Children and adolescents The efficacy and safety of amisulpride from the age of puberty up to 18 years has not been elucidated : available data on the use of amisulpride in adolescents with schizophrenia are limited. As a result, amisulpride is not recommended in pa Διαβάστε το πλήρες έγγραφο