Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
amisulpride, Quantity: 100 mg/mL
Sanofi-Aventis Australia Pty Ltd
Oral Liquid, solution
Excipient Ingredients: methyl hydroxybenzoate; hydrochloric acid; propyl hydroxybenzoate; purified water; potassium sorbate; saccharin sodium; gluconolactone; sodium gluconate; Flavour
Oral
60mL
(S4) Prescription Only Medicine
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.
Visual Identification: Clear yellow to yellow brown liquid with a characteristic caramel odour; Container Type: Bottle; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2004-02-12
SOLIAN ® _amisulpride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet is designed to provide answers to some common questions about this medicine. It does not contain all the available information. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Solian against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT SOLIAN IS USED FOR The name of your medicine is Solian. It contains the active ingredient called amisulpride. Solian belongs to a group of medicines called antipsychotics. Solian is used to treat symptoms of schizophrenia. Schizophrenia is a condition which affects the way you think, feel and/or act. Schizophrenia may cause symptoms such as hallucinations (e.g. hearing, seeing or sensing things which are not there), delusions, unusual suspiciousness, emotional and social withdrawal. People with schizophrenia may also feel depressed, anxious or tense. Your doctor may have prescribed Solian for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SOLIAN HAS BEEN PRESCRIBED FOR YOU. BEFORE TAKING IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE SOLIAN IF: • YOU HAVE AN ALLERGIC REACTION TO SOLIAN OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Signs of an allergic reaction may include a skin rash, itching, shortness of breath or swelling of the face, lips or tongue. • YOU ARE BREASTFEEDING OR PLAN TO BREASTFEED. • YOU ARE TAKING THE FOLLOWING MEDICINES: - medicines used to treat irregular heart rhythm such as quinidine, disopyramide, amiodarone and sotalol - cisapride - antibiotics such as erythromycin and pentamidine, given as an injection into the veins - levodopa, a medicine used in Parkinson's disease - thioridazone, an antipsychotic - methadone, medicine used to treat pain or addiction • THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING OR THE TABLETS DO NO Aqra d-dokument sħiħ
solian-ccdsv15-piv20-25feb22 Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION – SOLIAN (AMISULPRIDE) TABLETS AND SOLUTION 1 NAME OF THE MEDICINE Amisulpride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TABLETS SOLIAN tablets contain amisulpride (100 mg, 200 mg and 400 mg). Excipient with known effect: sugars as lactose. For the full list of excipients, see Section 6.1 List of excipients. SOLUTION SOLIAN solution contains amisulpride 100 mg/mL. Excipients with known effect: hydroxybenzoates, saccharin and sorbates. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM TABLETS SOLIAN 100: white to off white, flat-faced breakable tablet, engraved “AMI 100”. SOLIAN 200: white to off white, flat-faced breakable tablet, engraved “AMI 200”. SOLIAN 400: white, film-coated, breakable, oblong tablet, engraved “AMI 400”. SOLUTION SOLIAN 100 mg/mL: a clear, yellow to yellow-brown coloured liquid. solian-ccdsv15-piv20-25feb22 Page 2 of 20 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. 4.2 DOSE 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. Doses above 800 mg/d have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with amisulpride. Doses should be adjusted according to individual response. Doses should preferably be administered before meals. Amisulpride should be administered twice daily for doses above Aqra d-dokument sħiħ