देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
amisulpride, Quantity: 100 mg
Sanofi-Aventis Australia Pty Ltd
Amisulpride
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate type A; hypromellose; magnesium stearate; lactose monohydrate
Oral
30
(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: white to off-white, round, flat-faced, scored tablet marked "AMI 100"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2006-12-08
AMISULPRIDE WINTHROP ® _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 Amisulpride Winthrop 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 AMISULPRIDE WINTHROP IS USED FOR The name of your medicine is Amisulpride Winthrop. It contains the active ingredient called amisulpride. Amisulpride Winthrop belongs to a group of medicines called antipsychotics. Amisulpride Winthrop 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 Amisulpride Winthrop for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AMISULPRIDE WINTHROP HAS BEEN PRESCRIBED FOR YOU. BEFORE TAKING IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE AMISULPRIDE WINTHROP IF: • YOU HAVE AN ALLERGIC REACTION TO AMISULPRIDE WINTHROP 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, पूरा दस्तावेज़ पढ़ें
amisulpride-winthrop-ccdsv15-piv18-25feb22 Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION – AMISULPRIDE WINTHROP (AMISULPRIDE) TABLETS 1 NAME OF THE MEDICINE Amisulpride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AMISULPRIDE WINTHROP 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. 3 PHARMACEUTICAL FORM AMISULPRIDE WINTHROP 100: white to off white, flat-faced breakable tablet, engraved “AMI 100”. AMISULPRIDE WINTHROP 200: white to off white, flat-faced breakable tablet, engraved “AMI 200”. AMISULPRIDE WINTHROP 400: white, film-coated, breakable, oblong tablet, engraved “AMI 400”. 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. amisulpride-winthrop-ccdsv15-piv18-25feb22 Page 2 of 19 Doses should preferably be administered before meals. Amisulpride should be administered twice daily for doses above 400 mg. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the mi पूरा दस्तावेज़ पढ़ें