国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
amisulpride, Quantity: 400 mg
Arrotex Pharmaceuticals Pty Ltd
Amisulpride
Tablet, film coated
Excipient Ingredients: macrogol 6000; methylcellulose; purified talc; magnesium stearate; sodium starch glycollate type A; microcrystalline cellulose; basic butylated methacrylate copolymer; titanium dioxide; lactose monohydrate
Oral
10, 50, 90, 100, 60
(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, 18 x 8mm capsule shaped, film-coated tablets with breakline on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2011-11-03
APO-AMISULPRIDE 1 APO-AMISULPRIDE _Amisulpride _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about amisulpride. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR Amisulpride belongs to a group of medicines called antipsychotics. It 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • amisulpride • any of the ingredients listed at the end of this leaflet. Some symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES: • medicines used to treat irregular heart rhythm such as quinidine, disopyramide, amiodarone and sotalol • bepridil, used to treat angina • intravenous vincamine, used 完全なドキュメントを読む
1 AUSTRALIAN PRODUCT INFORMATION – APO-AMISULPRIDE (AMISULPRIDE) TABLET 1 NAME OF THE MEDICINE Amisulpride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg, 100 mg, 200 mg or 400 mg amisulpride as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Amisulpride tablets contain sugars as lactose. Amisulpride tablets are gluten free. For the full list of excipients see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 50 MG TABLETS: White to off-white 6.0 mm, round, biconvex tablets with breakline on one side. 100 MG TABLETS: White to off-white 8.0 mm, round, flat tablets with breakline on one side. 200 MG TABLETS: White to off-white 11.0 mm, round, flat tablets with breakline on one side. 400 MG TABLETS: White to off-white, 18 x 8 mm capsule shaped film-coated tablets with breakline on one side. 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 Amisulpride tablets are intended for oral 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 2 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 400 mg. For patients with mixed positive and negative symptoms, doses should be adjusted t 完全なドキュメントを読む