Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Acarbose
Bayer Plc
A10BF01
Acarbose
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010203; GTIN: 5010605048029
GLUCOBAY 100MG TABLETS (acarbose) PATIENT INFORMATION LEAFLET 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. Your medicine is called Glucobay 100mg Tablets but will be referred to as Glucobay throughout the leaflet. WHAT IS IN THIS LEAFLET: What Glucobay is and what it is used for What you need to know before you take Glucobay How to take Glucobay Possible side effects How to store Glucobay Contents of the pack and other information WHAT GLUCOBAY 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._ GLUCOBAY IS USED TO TREAT NON-INSULIN DEPENDENT DIABETES. It 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 well enough. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLUCOBAY DO NOT TAKE GLUCOBAY: * IF YOU ARE ALLERGIC to acarbose or any of the other ingredients of this medicine (listed in section 6). * IF YOU ARE PREGNANT OR BREAST-FEEDING. * 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 A SEVERE LIVER DISORDER. * IF YOU HAVE AN INTESTINE DISEASE where you do not digest or absorb food properly. * IF YOU HAVE A LARGE H Read the complete document
OBJECT 1 GLUCOBAY 100 MG TABLETS Summary of Product Characteristics Updated 10-Oct-2017 | Bayer plc 1. Name of the medicinal product Glucobay 100 mg tablets 2. Qualitative and quantitative composition GLUCOBAY 100 MG TABLETS: 1 tablet contains 100 mg acarbose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet for oral administration. White to yellow-tinged oval oblong, convex tablets of 13 mm length, 6 mm width and 5.5 mm radius of curvature with 'G score 100' on one side and a 'score' on the other. 4. Clinical particulars 4.1 Therapeutic indications INDICATIONS Glucobay is recommended for the treatment of non-insulin dependent (NIDDM) diabetes mellitus in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents. 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 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 Read the complete document