Package insert/Patient information leaflet
Glucobay 100
Tablets each containing 100 mg acarbose.
Glucobay 100 tablets also contain starch, cellulose, magnesium stearate and silicon dioxide.
Glucobay 100 is the first product in a class known as glucosidase inhibitors which delay the digestion of carbohydrates in the intestine.
Made by: Bayer AG, Leverkusen, Germany
Product Licence holder: Bayer plc, Pharmaceutical Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA.
Distributed in the Republic of Ireland by: Bayer Ltd, Dun Laoghaire, Co Dublin.
Please read this leaflet carefully before taking Glucobay
Why have I been prescribed Glucobay 50 by my doctor?
Glucobay has been prescribed for you by your doctor to treat your diabetes. Glucobay will help to control your blood sugar levels. This is because Glucobay 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.
When should I NOT take Glucobay
Do not take Glucobay if you have previously had an allergic reaction to any of the ingredients. If you are unsure about this ask your doctor.
Do not take Glucobay if you are pregnant or breast-feeding. If you are taking Glucobay and think that you may be pregnant, or are planning a family, consult your doctor.
Do not take Glucobay if you have a liver disorder.
Do not take Glucobay if you suffer from inflammation or ulceration of the bowel, e.g. ulcerative colitis or Crohn's disease.
If you have a kidney disorder or a hernia, or have had previous abdominal surgery, do not take Glucobay without consulting your doctor first.
What special precautions should I take?
Treating hypoglycaemic episodes ("hypos "):
As a diabetic you may also be receiving other treatments for your diabetes. If you are taking insulin or sulphonylurea drugs to control your blood sugar, you will probably be used to avoiding hypoglycaemic episodes by taking sugar when you feel that your blood sugar level is too low.
When taking Glucobay do not treat a hypoglycaemic episode with ordinary sugar (sucrose). Instead take some GLUCOSE (also known as dextrose) tablets, syrup, or sweets which should be available from your local chemist.
When and how do I take Glucobay
To gain the maximum benefit from Glucobay you should adhere to the diet prescribed for you by your doctor. This will also help in reducing any side-effects you may experience.
Take the tablets as prescribed by your doctor. This
will normally be one or two tablets taken with meals three times a day. However, when you first start your treatment, your doctor may recommend that you take your tablets once or twice a day before increasing your dose to three times a day. Glucobay tablets should be chewed with the first mouthful of food. If you prefer not to chew the tablets then swallow them whole with a little liquid immediately before the meal.
Do not exceed the prescribed dose
If you do exceed the prescribed dose, or in the event of an overdose, avoid the intake of carbohydrate-containing food or drinks and seek medical advice. Exceeding the correct dosage may cause diarrhoea and other intestinal symptoms such as flatulence (wind) and abdominal cramps.
What should I do if I miss one or more doses?
If you forget to take one or more doses of Glucobay do not take the tablets between meals but, instead wait until your next scheduled dose and meal and continue as before.
What undesirable effects may I experience?
During the first few days or weeks of treatment with Glucobay you may experience increased flatulence (wind), a feeling of fullness and possibly abdominal cramps. It is also possible that you may pass softer stools or even experience diarrhoea, particularly after a meal containing sugar or sucrose-containing foods. Normally, these symptoms will disappear if you continue treatment and keep to your prescribed diet.
Do not take indigestion (antacid) preparations for treating these symptoms as they are unlikely to have any beneficial effect.
If your symptoms persist for more than 2 or 3 days, or if they are severe consult your doctor, particularly in the case of diarrhoea.
Less common side-effects include inflammation of the liver (hepatitis), jaundice (yellowing of the skin) and skin reactions such as redness, rash and uticaria (hives).
Glucobay tablets may cause an increase in the results of certain liver function tests. These effects go away when treatment is stopped.
If you experience any other undesirable effects, tell your doctor immediately.
How should I store my Glucobay tablets?
It is best if you keep Glucobay tablets in the original carton supplied. The tablets should be kept in a cool, dry place where the temperature is not likely to exceed 25ºC.
Keep out of the reach of children
Do not use tablets beyond the expiry date which is marked on both the outer container and on each blister strip of tablets. For example, EXP 2/99 means that your tablets must not be used after February 1999.
If you find that you have tablets after their expiry date, return them to your local pharmacist who will dispose of them properly.
Remember: This medicine has been prescribed for you. Do not give it to anyone else under any circumstances. If you have any doubts about taking Glucobay correctly seek the advice of your doctor.
Date of preparation: November 1995
Product Licence Number: PL 0010/0171
Product Authorisation Number: PA 21/40/1