Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Acarbose
Bayer Limited
A10BF; A10BF01
Acarbose
100 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Alpha glucosidase inhibitors; acarbose
Not marketed
1992-06-04
BP14115 PACKAGE LEAFLET - INFORMATION FOR THE USER GLUCOBAY 100 MG TABLETS ACARBOSE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT GLUCOBAY IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE GLUCOBAY 3. HOW YOU TAKE GLUCOBAY 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE GLUCOBAY 6. FURTHER INFORMATION 1. WHAT GLUCOBAY IS AND WHAT IT IS USED FOR Glucobay contains acarbose, which belongs to a group of medicines called _glucosidase inhibitors._ GLUCOBAY IS USED TO TREAT DIABETES Glucobay helps to control your blood sugar levels. It works by slowing down the digestion of carbohydrates _(complex sugars)_ which reduces the abnormally high blood sugar levels in your body after each meal. Glucobay can be used to treat diabetes when a restricted diet alone or a restricted diet plus other sugar- lowering drugs do not work enough. 2. BEFORE YOU TAKE GLUCOBAY DO NOT TAKE GLUCOBAY: • IF YOU ARE ALLERGIC to the active ingredient (acarbose), or to any of the other ingredients. The ingredients are listed in section 6. • IF YOU ARE PREGNANT OR BREASTFEEDING. • IF YOU HAVE INFLAMMATION OR ULCERATION OF THE BOWEL, for example ulcerative colitis or Crohn’s disease. • IF YOU HAVE AN OBSTRUCTION IN YOUR INTESTINES, or are likely to get this. • IF YOU HAVE AN INTESTINE DISEASE where you do not digest or absorb food properly. • IF YOU HAVE A LARGE HERNIA, or any other condition where increased gas in your intestine may make it worse. • IF YOU HAVE SEVERE LIVER IMPAIRMENT (e.g. liver cirrhosis) • IF YOU HAVE SEVERE RENAL IMPAIRMENT. →TELL YOUR DOCTOR if any of these apply to you and DO N Baca dokumen lengkap
Health Products Regulatory Authority 18 November 2019 CRN009GFY Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glucobay 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Acarbose 100 mg. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tablets White to yellow-tinged oval oblong, convex tablets of 13 mm length, 6 mm width and 5.5 mm radius of curvature. On one side the tablet code is ‘G’, score and 100 and on the other side score. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INDICATIONS Glucobay is recommended: 1. as an adjunct to diet, in combination with insulin, in the management of insulin dependent diabetes mellitus (IDDM), or 2. as an adjunct to diet, alone or in combination with insulin or oral hypoglycaemic agents, in the management of non-insulin dependent diabetes mellitus (NIDDM). MODE OF ACTION Glucobay is a competitive inhibitor of intestinal alpha-glucosidases with maximum specific inhibitory activity against sucrase. Under the influence of Glucobay, the digestion of starch and sucrose into absorbable monosaccharides in the small intestine is dose-dependently delayed. In diabetic subjects, this results in a lowering of postprandial hyperglycaemia and a smoothing effect on fluctuations in the daily blood glucose profile. In contrast to sulphonylureas Glucobay has no stimulatory action on the pancreas. Treatment with Glucobay also results in a reduction of fasting blood glucose and to modest changes in levels of glycated haemoglobin (HbA 1 , HbA 1c ). The changes may be a reduction or reduced deterioration in HbA 1 or HbA 1c levels, depending upon the patient's clinical status and disease progression. These parameters are affected in a dose-dependent manner by Glucobay. Following oral administration, only 1-2% of the active inhibitor is absorbed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Glucobay tablets are taken orally and should be chewed with the first mo Baca dokumen lengkap