Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
Amisulpride
Sanofi-Aventis Australia Pty Ltd
Medicine Registered
SOLIAN ® _amisulpride_ CONSUMER MEDICINE INFORMATION (CMI) 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 (eg 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 Прочитајте комплетан документ
Solian PI Page 1 CCDSv6 PIv11 9 Sep 13 PRODUCT INFORMATION SOLIAN ® TABLETS AND SOLUTION NAME OF THE MEDICINE SOLIAN 50 SOLIAN 100 SOLIAN 200 SOLIAN 400 SOLIAN SOLUTION 100mg/mL NON-PROPRIETARY NAME Amisulpride CHEMICAL STRUCTURE Chemical Name: (R, S)-4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-ethylsulfonyl-2- methoxybenzamide Molecular Weight: 369.48 Molecular Formula: C 17 H 27 N 3 O 4 S CAS NUMBER 71675-85-9 DESCRIPTION Amisulpride is a white to off-white powder, which is practically insoluble in water, sparingly soluble in ethanol, soluble in methanol and freely soluble in dichloromethane. SOLIAN Tablets contain amisulpride (50 mg, 100 mg, 200 mg and 400 mg) and the following excipients: 50, 100 and 200 mg tablets: sodium starch glycollate type A, lactose, microcrystalline cellulose, hypromellose, magnesium stearate. 400 mg tablets: sodium starch glycollate type A, lactose, microcrystalline cellulose, hypromellose, magnesium stearate, Peg-40 stearate, titanium dioxide. Solian PI Page 2 CCDSv6 PIv11 9 Sep 13 SOLIAN SOLUTION contains amisulpride 100mg/mL and the following excipients: hydrochloric acid, methyl hydroxybenzoate, propyl hydroxybenzoate, potassium sorbate and purified water. and the following proprietary ingredients: Gesweet ® 2023 (ARTG No 10553) and Caramel Flavour E9422058 (ARTG No 10645) PHARMACOLOGY CLASS Neuroleptic of the benzamide class PHARMACODYNAMICS Amisulpride binds selectively to the human dopaminergic D 2 (Ki 2.8 nM) and D 3 (Ki 3.2 nM) receptor subtypes without any affinity for D 1 , D 4 and D 5 receptor subtypes (Ki > 1 Прочитајте комплетан документ