देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amisulpride
Viatris UK Healthcare Ltd
N05AL05
Amisulpride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5016695301174
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs v3/July 2017 Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info 3D Render ID 1/2 1 Myriad Pro 9 pt 9 pt 170 x 480 mm Amisulpride 400 mg,50 mg,100 mg 60 Leaflet 2198057 2096107 2198057 PL 04569/1508 PL 04569/1509 PL04569/1511 N/A LT1934AF 850 400525914, 400525915 400525916, 400525917 552740 1 United Kingdom N/A N/A N/A Black 21:14 10 Jun 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMISULPRIDE 50 MG, 100 MG, 200 MG TABLETS AMISULPRIDE 400 MG FILM‑COATED TABLETS amisulpride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Amisulpride is and what it is used for 2. What you need to know before you take Amisulpride 3. How to take Amisulpride 4. Possible side effects 5. How to store Amisulpride 6. Contents of the pack and other information 1. WHAT AMISULPRIDE IS AND WHAT IT IS USED FOR Amisulpride Tablets contain amisulpride and belongs to a group of medicines called antipsychotics which help to control the symptoms of a mental illness called schizophrenia. Symptoms include: • delusions (having strange or unusual thoughts) • hallucinations (seeing or hearing things that are not there) • being suspicious or aggressive for no apparent reason (these are so पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amisulpride 50 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg amisulpride. Excipient with known effect: Each tablet contains 16.28 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White round tablet with ‘AA 50’ on one side and ‘G’ on the reverse, 6 mm in diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders with: • positive symptoms (such as delusions, hallucinations, thought disorders, hostility, suspiciousness), and/or • negative symptoms (deficit syndrome) such as blunted affect, emotional and social withdrawal This includes patients with predominant negative symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Positive symptoms: _ For acute psychotic episodes, a daily dose between 400 mg and 800 mg is recommended. In individual cases, the daily dose may be increased up to 1200 mg. Doses above 1200 mg/day have not been extensively evaluated for safety and therefore should not be used. No specific titration is required when initiating treatment. Doses should be adjusted according to individual response. 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 minimally effective dose. _Predominant negative symptoms (deficit syndrome) _ A daily dose between 50 mg and 300 mg is recommended. Doses should be adjusted individually. Amisulpride can be administered once daily at doses up to 300 mg, higher doses should be administered twice daily. The minimum effective dose should be used. _Special populations _ _Elderly patients over 65 years _ Treatment of elderly patients is not recommended. The safety of amisulpride has been examined in a limited number of elderly patients. If treatment with amisulpride is ab पूरा दस्तावेज़ पढ़ें