Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
acarbose
Bayer Australia Ltd
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 IF: • you have a severe kidney disorder (creatinine clearance < 25 mL/min). • you suffer from intestinal obstruction, inflammation or ulceration of the bowel, e.g. ulcerative colitis or Crohn’s disease. • you have a hernia or have had previous abdominal surgery. If so, consult your doctor first. DO NOT GIVE THIS MEDICINE TO A CHILD UNDER THE AGE OF Read the complete document
180703 GLUCOBAY PI 1 PRODUCT INFORMATION GLUCOBAY ® (acarbose) 1. NAME OF THE MEDICINE Acarbose 2. QUALITATIVE AND QUANTITATIVE COMPOSITION GLUCOBAY tablets contain acarbose 50 mg or 100 mg. For the list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM 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 round, convex, white to yellow-tinged tablets, marked with “G” and “100”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct to prescribed diet and exercise for the management of blood glucose concentrations in non-insulin dependent diabetic patients who are inadequately controlled by diet alone or by diet and oral hypoglycaemic agents. 4.2 DOSE AND METHOD OF ADMINISTRATION Since the activity and the tolerability of GLUCOBAY varies from individual to individual, the optimal dosage must be individualised. GLUCOBAY tablets should be swallowed whole with a little liquid directly before a meal or chewed with the first few mouthfuls of the meal. In adults, GLUCOBAY should be started at a low initial dose and be increased slowly to minimise the gastrointestinal side effects. Treatment is usually commenced at 50 mg once daily for the first week, 50 mg twice daily for the second week and 50 mg three times a day for the third week. A further increase of the dose may be necessary after 4 - 8 weeks on the basis of the blood glucose level. The average adult dose is 100 mg GLUCOBAY three times daily. A further increase to 200 mg GLUCOBAY three times daily may occasionally be necessary (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). If gastrointestinal symptoms are not tolerated despite close adherence to the prescribed diet, a reduction in the dose should be considered. No modification of the adult dosage regimen is necessary in the elderly. 180703 GLUCOBAY PI 2 4.3 CONTRAINDICATIONS Hypersensitivity to acarbose and/or any of t Read the complete document