Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Sanofi-Aventis South Africa (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS AMISULPRIDE 200,0 mg
Registered
2002-03-06
_ _ _ _ _ _ sanofi-aventis south africa (pty) ltd Solian 50 mg & 200 mg (Tablets) 50 mg or 200 mg amisulpride per tablet DATE OF APPROVAL: 31 March 2023 Page 1 of 13 PATIENT INFORMATION LEAFLET FOR SOLIAN PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S5 SOLIAN ® 50 MG TABLETS SOLIAN ® 200 MG TABLETS AMISULPRIDE CONTAINS SUGAR: SOLIAN 50 mg: Each tablet contains 34,80 mg lactose monohydrate. SOLIAN 200 mg: Each tablet contains 139,20 mg lactose monohydrate. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING SOLIAN. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. • SOLIAN has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS 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. _ _ _ _ _ _ sanofi-aventis south africa (pty) ltd Solian 50 mg & 200 mg (Tablets) 50 mg or 200 mg amisulpride per tablet DATE OF APPROVAL: 31 March 2023 Page 2 of 13 1. WHAT SOLIAN IS AND WHAT IT IS USED FOR SOLIAN contains a medicine called amisulpride. This belongs to a group of medicines called antipsychotics. It is used to treat a mental illness called schizophrenia. Schizophrenia can make you feel, see or hear things which do not exist, have strange and frightening thought(s), be suspicious or aggressive for no apparent reason, 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 behaviours. 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 SOLIAN IF: • you are allergic (hypersensitive) to amisulpride or to any of the other ingredients Read the complete document
_ _ _ _ _ _ sanofi-aventis south africa (pty) ltd Solian 50 mg & 200 mg (Tablets) 50 mg or 200 mg amisulpride per tablet DATE OF APPROVAL: 31 March 2023 Page 1 of 17 PROFESSIONAL INFORMATION FOR SOLIAN SCHEDULING STATUS S5 1. NAME OF THE MEDICINE SOLIAN ® 50 MG tablets SOLIAN ® 200 MG tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SOLIAN 50 MG: Each tablet contains 50 mg amisulpride. SOLIAN 200 MG: Each tablet contains 200 mg amisulpride. EXCIPIENTS WITH KNOWN EFFECT SOLIAN 50 MG: Contains sugar (lactose monohydrate): 34,80 mg per tablet. SOLIAN 200 MG: Contains sugar (lactose monohydrate): 139,20 mg per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. SOLIAN 50 MG: Round, white to off-white, flat-faced tablet, engraved AMI 50 on one face of the tablet. SOLIAN 200 MG: Round, white to off-white, flat-faced, breakable tablet, engraved AMI 200 on one face and with a breakable bar on the other face of the tablet. _ _ _ _ _ _ sanofi-aventis south africa (pty) ltd Solian 50 mg & 200 mg (Tablets) 50 mg or 200 mg amisulpride per tablet DATE OF APPROVAL: 31 March 2023 Page 2 of 17 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SOLIAN is indicated for the treatment of patients with acute and chronic schizophrenia, including patients characterised by predominant negative symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY No specific titration is required when initiating the treatment with SOLIAN and doses should be adjusted according to the individual response. SOLIAN can be administered once daily at oral doses up to 400 mg, higher doses should be administered twice daily. The minimum effective dose should be used. _ADULTS _ _For acute schizophrenia: _ Oral doses between 400 – 800 mg/day are recommended. In individual cases, the dose may be increased up to 1 200 mg/day. Doses above 1 200 mg/day have not been evaluated for safety and therefore should not be used. _For patients with mixed positive and negative symptoms: _ Doses should be adjusted to obtain opti Read the complete document