Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Acarbose
Bayer Australia Ltd
Medicine Registered
GLUCOBAY ® CMI 1 GLUCOBAY ® (GLUE·CO·BAY) _acarbose_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Glucobay. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Glucobay against the benefits they expect it will have for you. As Glucobay is a prescription medicine, it should only be used under medical supervision. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GLUCOBAY IS USED FOR Glucobay tablets contain the active drug acarbose. They are used for the treatment of diabetes . Glucobay helps to control your blood sugar levels in conjunction with diet, exercise, weight loss and other measures by slowing down the digestion of carbohydrates (complex sugars) from your diet. This reduces the abnormally high blood sugar levels that occur after each meal. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE GLUCOBAY _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE GLUCOBAY IF YOU HAVE AN ALLERGY TO: • acarbose, the active ingredient in Glucobay • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE GLUCOBAY I Read the complete document
PRODUCT INFORMATION GLUCOBAY ® (acarbose) NAME OF THE MEDICINE GLUCOBAY contains acarbose (CAS number 56180-94-0) which is a complex oligosaccharide of microbial origin. Acarbose is made up of an unsaturated cyclitol unit, an amino sugar and a maltose residue. It has a molecular weight of 645.6. The chemical structure is shown below: DESCRIPTION In addition to acarbose, GLUCOBAY tablets contain the following inactive ingredients: cellulose, corn starch, silica colloidal anhydrous and magnesium stearate. GLUCOBAY 50 MG tablets are round, biconvex, white to yellow-tinged tablets, marked with the Bayer cross on the one side and “G” and “50” on the reverse side. GLUCOBAY 100 MG tablets are oval oblong, convex, white to yellow-tinged tablets, marked with a score on the one side, and “G” and “100” (divided by a score line) on the reverse side. PHARMACOLOGY PHARMACOKINETICS ABSORPTION: One to 2% of an oral dose of acarbose is absorbed from the gastrointestinal tract as unchanged drug. After the oral administration of 200mg 14 C-labelled acarbose (200mg) to 6 healthy volunteers, approximately 35% of total radioactivity (changed and unchanged drug) appeared in the urine. An average of 51% of the oral dose was excreted in the faeces as unabsorbed drug-related radioactivity within 96 hours of ingestion. The proportion of active substance excreted in the urine was 1.7% of the administered dose. The low systemic bioavailability of the parent drug is therapeutically desired, because acarbose acts locally within the gastrointestinal tract. Following oral dosing with acarbose, peak plasma concentrations of radioactivity were attained 14 - 24 hours after dosing (586.3 ± 282.7 µg/L after 20.7 ± 5.2 hours), while peak plasma concentrations of active drug were attained at ap Read the complete document