Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Amisulpride 50mg
Viatris Limited
Amisulpride 50 mg
50 mg
Tablet
Active: Amisulpride 50mg Excipient: Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium starch glycolate
Prescription
Laboratorios Espinos Y Bofill SA (LEBSA)
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.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 50 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 100 tablets - 24 months from date of manufacture stored at or below 25°C
2013-06-25
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION SULPRIX ® _AMISULPRIDE TABLETS 100 MG, 200 MG AND 400 MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Sulprix. This leaflet answers some common questions about Sulprix. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SULPRIX 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 THE MEDICINE. You may need to read it again. WHAT SULPRIX IS USED FOR Sulprix is used to treat symptoms of schizophrenia, which is a condition that affects the way you think, feel and/or act. Schizophrenia may cause symptoms such as hallucinations, delusions, unusual suspiciousness, emotional and social withdrawal. People with schizophrenia may also feel depressed, anxious or tense. Sulprix contains the active ingredient amisulpride. It belongs to a group of medicines called antipsychotics. Your doctor may have prescribed it for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE SULPRIX _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE SULPRIX IF YOU HAVE AN ALLERGY TO: • any medicine containing amisulpride • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE SULPRIX IF YOU ARE TAKING THE FOLLOWING MEDICINES: • medicines used to treat irregular heart rhythm or heart conditions such as quinidine, disopyramide, amiodarone, sotalol and bepridil • antibiotics such as erythromycin and pentamidine, given as an injection into th Đọc toàn bộ tài liệu
Page 1 of 15 NEW ZEALAND DATA SHEET SULPRIX ® 1. PRODUCT NAME SULPRIX, 50 mg, 100 mg & 200 mg, tablet. SULPRIX, 400 mg, film coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg, 100 mg, 200 mg or 400 mg of amisulpride. Excipient with known effect: lactose monohydrate Allergen declaration: sugars as lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM SULPRIX Tablets 50 mg: White round shaped tablets with 'AA 50' on one side and 'G' on the reverse, approximately 6 mm in diameter. SULPRIX Tablets 100 mg: White round shaped tablets with 'AMI' breakline '100' on one side and 'G' on the reverse, approximately 7.5 mm in diameter. SULPRIX Tablets 200 mg: White round shaped tablets with 'AMI' breakline '200' on one side and 'G' on the reverse, approximately 10 mm in diameter. SULPRIX Film-coated Tablets 400 mg: White film-coated, 18.0 ± 0.5 mm capsule shaped tablet, embossed with "AS 400" on one side and a break-line on the reverse. The 100 mg, 200 mg and 400 mg tablets can be divided into equal doses. 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/day and 800 mg/day are recommended. In individual cases, the daily dose may be increased up to 1200 mg/day. Doses above 1200 mg/day have not been extensively evaluated for safety and therefore should not be used. Doses above 800 mg/day have not been shown to be superior to lower doses and may increase the incidence of Page 2 of 15 adverse events. No specific titration is required when initiating the treatment with amisulpride. Doses should be adjusted according to individual res Đọc toàn bộ tài liệu