Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
amisulpride
Sanofi-Aventis Australia Pty Ltd
Amisulpride
Registered
Amisulpride Sandoz CMI Page 1 Amisulpride Sandoz ® _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 Sandoz 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 SANDOZ IS USED FOR The name of your medicine is Amisulpride Sandoz. It contains the active ingredient called amisulpride. Amisulpride Sandoz belongs to a group of medicines called antipsychotics. Amisulpride Sandoz 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 Amisulpride Sandoz for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AMISULPRIDE SANDOZ HAS BEEN PRESCRIBED FOR YOU. BEFORE TAKING IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE AMISULPRIDE SANDOZ IF: • YOU HAVE AN ALLERGIC REACTION TO AMISULPRIDE SANDOZ 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 - th Lesen Sie das vollständige Dokument
amisulpride-sandoz-ccdsv13-piv16-27sep19 Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION – AMISULPRIDE SANDOZ (AMISULPRIDE) TABLETS 1 NAME OF THE MEDICINE Amisulpride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AMISULPRIDE SANDOZ Tablets contain amisulpride (100 mg, 200 mg and 400 mg). Excipient with known effect: Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM AMISULPRIDE SANDOZ 100mg: white to off white, flat-faced breakable tablet, engraved “AMI 100”. AMISULPRIDE SANDOZ 200mg: white to off white, flat-faced breakable tablet, engraved “AMI 200”. AMISULPRIDE SANDOZ 400mg: 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-sandoz-ccdsv13-piv16-27sep19 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 minimall Lesen Sie das vollständige Dokument