País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
amisulpride, Quantity: 200 mg
Southern Cross Pharma Pty Ltd
Amisulpride
Tablet, uncoated
Excipient Ingredients: hypromellose; lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type A
Oral
90, 30, 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, round, flat tablets, scored on one side with diameter 11.5 mm; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-01-29
Amisulpride Sandoz Pharma 1 AMISULPRIDE SANDOZ PHARMA CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKE AMISUPRIDE SANDOZ PHARMA? Amisulpride Sandoz Pharma contains the active ingredient amisulpride. Amisulpride Sandoz Pharma is used to the symptoms of schizophrenia, a condition which affects the way you think, feel or act. For more information, see Section 1. Why am I take Amisulpride Sandoz Pharma? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE AMISULPRIDE SANDOZ PHARMA? Do not take if you have ever had an allergic reaction to amisulpride or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take Amisulpride Sandoz Pharma? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Amisulpride Sandoz Pharma and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE AMISULPRIDE SANDOZ PHARMA? • Tablets should be taken once or twice a day as advised by your doctor. Your doctor will tell you how many tablets to take. • Swallow the tablets whole with a full glass of water. • Your doctor may increase or decrease your dose depending on your condition. More instructions can be found in Section 4. How do I take Amisulpride Sandoz Pharma? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING AMISULPRIDE SANDOZ PHARMA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Amisulpride Sandoz Pharma. • Tell your doctor if you are starting any other new medicine. • Tell your doctor if your mood changes, including feelings of depression or thoughts of self-harm. THINGS YOU SHOULD NOT DO • Do not stop takin Leia o documento completo
AUSTRALIAN PRODUCT INFORMATION AMISULPRIDE SANDOZ PHARMA, (AMISULPRIDE) TABLETS 1. NAME OF THE MEDICINE Amisulpride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amisulpride Sandoz Pharma uncoated tablets contain the active amisulpride. Amisulpride Sandoz Pharma uncoated tablets are available in three strengths and contain either 100 mg, 200 mg or 400 mg of amisulpride. Excipients with known effect: lactose monohydrate. For the full list of excipients (see Section 6.1 LIST OF EXCIPIENTS). 3. PHARMACEUTICAL FORM Amisulpride Sandoz Pharma 100 mg uncoated tablets are white round flat tablet, embossed with MC on one side. Amisulpride Sandoz Pharma 200 mg uncoated tablets are white round flat tablet scored on one side. Amisulpride Sandoz Pharma 400 mg uncoated tablets are white biconvex, capsule shaped tablet scored on both sides. 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. Doses should preferably be administered before meals. Amisulpride should be administered bid 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 tre Leia o documento completo