Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
ACARBOSE
McDermott Laboratories Ltd t/a Gerard Laboratories
ACARBOSE
100 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PAGE 1 OF 5 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 the 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. WHAT IS IN THIS LEAFLET: 1. What Acarbose is and what it is used for. 2. What you need to do 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 The active ingredient in this medicine is acarbose. This belongs to a group of medicines called glucosidase inhibitors. Acarbose is used in the treatment of non-insulin dependent diabetes mellitus in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents. Acarbose is indicated in 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 slowing down the digestion of carbohydrates (complex sugars) from your diet, and this reduces the abnormally high blood sugar levels that occur after each meal. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACARBOSE DO NOT TAKE ACARBOSE • if you are allergic to acarbose or any of the other ingredients read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acarbose 100 mg 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 A white to off-white, 11/32” round, biconvex tablet debossed with AB breakline 100 on one side of the tablet and M on the other side. 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 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 (see Special warnings and precautions for use, section 4.4). If distressing complaints develop in spite of strict adherence to the diet, the dose should not be increased further read_full_document