Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Acarbose
Viatris UK Healthcare Ltd
A10BF01
Acarbose
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010203; GTIN: 5016695000053
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Glams Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs v1/May 2015 20 May 2016 1/2 11:12 Acarbose 50/100mg 90 Leaflet 898213 671958 898213 04569/1619,04569/1620 NA 50061535 4851 NA 281544 1 NA UK NA NA 1 Black Myriad Pro 170 x 360mm 9 pt 8 pt 50061535 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACARBOSE 50 MG TABLETS ACARBOSE 100 MG TABLETS (acarbose) 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 Acarbose is and what it is used for 2. What you need to know before you take Acarbose 3. How to take Acarbose 4. Possible side effects 5. How to store Acarbose 6. Contents of the pack and other information 1. WHAT ACARBOSE IS AND WHAT IT IS USED FOR Acarbose contains the active substance acarbose, which belongs to a group of medicines called glucosidase inhibitors. Acarbose is used in the treatment of non-insulin dependent (type II) diabetes mellitus in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents. Acarbose is for adults aged over 18 years. This medicine has been prescribed for you by your doctor to treat your diabetes. Acarbose will help to control your blood sugar levels. This is because acarbose works by sl Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acarbose 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg acarbose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, round biconvex tablet intagliated with AB breakline 100 on one side and M on the reverse. The score line is not intended for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acarbose is indicated in adults and adolescents aged over 18 years. Acarbose is recommended for the treatment of type II diabetes mellitus in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Owing to the great individual variation of glucosidase activity in the intestinal mucosa, there is no fixed dosage regimen, and patients should be treated according to clinical response and tolerance of intestinal side-effects. The recommended initial dose is 50 mg three times a day. However, some patients may benefit from more gradual initial dose titration to minimise gastrointestinal side-effects. This may be achieved by initiating treatment at 50 mg once or twice a day, with subsequent titration to a three times a day regimen. If after six to eight weeks' treatment patients show an inadequate clinical response, the dosage may be increased to 100 mg three times a day. A further increase in dosage to a maximum of 200 mg three times a day may occasionally be necessary. Patients receiving the maximum dose require careful monitoring. If distressing complaints develop in spite of strict adherence to the diet, the dose should not be increased further, and if necessary should be reduced according to the severity of the side- effects and the clinical judgment of the prescriber. The average dose is 300 mg Acarbose/day (corresponding to 3 x 2 tablets of 50 mg Acarbose/day, or 3 x 1 tablet of 100 mg Acarbose/day). Acarbose is intended for continuous long-term treatment. _Elde Lire le document complet