PACKAGE LEAFLET DIASTABOL 50 MG TABLETS. Version 1.0 1

Transcription

1 PACKAGE LEAFLET DIASTABOL 50 MG TABLETS 1

2 PACKAGE LEAFLET: INFORMATION FOR THE USER Diastabol 50 mg tablets miglitol 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 effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Diastabol is and what it is used for 2. Before you take Diastabol 3. How to take Diastabol 4. Possible side effects 5. How to store Diastabol 6. Further information 1. WHAT DIASTABOL IS AND WHAT IT IS USED FOR Diastabol is an oral anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus in adults. It is a alpha-glucosidase inhibitor which works by slowing down the digestion of carbohydrates (complex sugars) from your diet, and this reduces the abnormally high sugar levels in your blood that occur after each meal. This medicine is recommended for the treatment of type 2 diabetes mellitus when diet alone or diet and a sulfonylurea (another type of oral anti-diabetic medicine) provide insufficient results. Diastabol should be used as a supplement to diet or diet combined with sulfonylureas. 2. BEFORE YOU TAKE DIASTABOL Do not take Diastabol - if you are allergic (hypersensitive) to miglitol or any of the other ingredients of Diastabol. - if you are under 18 years of age. - if you are breast-feeding. - if you have any of the following gastrointestinal disorders: inflammation or ulceration of the bowel; obstruction in your intestines or predisposition for obstruction; intestinal disease whereby you do not digest or absorb food properly; large hernia or any other condition where increased gas in your intestine may make it worse. - if you have a severe kidney impairment. Take special care with Diastabol - if you are taking other treatments (insulin or sulfonylurea drugs) for your diabetes, you will probably be used to avoiding hypoglycaemic episodes by taking sugar when you feel that your blood sugar level is too low (hypoglycaemia). 2

3 When taking Diastabol, do not treat a hypoglycaemic episode with ordinary sugar (sucrose). Instead take some glucose (also known as dextrose) tablets, syrup, or sweets, which are available from your pharmacist. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken the following medications which can influence the effect of or be affected by Diastabol: - Drugs known as intestinal adsorbants to control diarrhoea or the consistency of your stools, or drugs to help your digestion (digestive enzyme preparations, e.g. pancreatin and amylase), may reduce the effect of Diastabol and should not be taken at the same time as Diastabol. - The effect of laxatives, drugs used to help constipation, may be increased by the use of Diastabol. - As Diastabol may cause diarrhoea, it may modify the effect of some medicines taken orally, particularly long-acting medicines (e.g. those that are named slow-release, extended-release, modified release or sustained release ). - In clinical trials, Diastabol been shown to slightly reduce the amount of the following medicines in the body, but there is no evidence that this changes these drugs effectiveness: digoxin, a drug used to treat heart conditions, glibenclamide or metformin, drugs used to treat diabetes, propranolol, a drug used to treat high blood pressure and heart conditions. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Diastabol with food and drink Diastabol tablets should be chewed with the first mouthful of food, or swallowed whole with a little liquid immediately before the meal. Pregnancy and breast-feeding Diastabol should not be used during pregnancy. Tell your doctor if you are, you think you might be or are planning to become pregnant. Diastabol must not be used during the breast-feeding period. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines When you take miglitol with a sulfonylurea you should be alerted to the possible risk of hypoglycaemia. Hypoglycaemia may impair alertness and reactions, which may, for example, affect the ability to drive or to operate machinery. 3. HOW TO TAKE DIASTABOL Always take Diastabol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual starting dose is one Diastabol 50 mg tablet three times a day. Depending on how you tolerate Diastabol, after 4 to 12 weeks of treatment, your doctor may increase the dose to one Diastabol 100 mg tablet (or two Diastabol 50 mg tablets) three times a day. To gain the maximum benefit from Diastabol you should stick to the diet prescribed for you by your doctor. Diastabol tablets are taken orally, and should be chewed with the first mouthful of food or swallowed whole with a little liquid directly before the meal. If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor. Do not take more tablets than your doctor has prescribed. Continue the treatment throughout the whole period indicated by your doctor. 3

4 If you take more Diastabol than you should If you take more medication than prescribed, or in the event of an overdose, you may experience gastrointestinal symptoms such as flatulence (wind), diarrhoea and abdominal pain. You may also experience a swollen abdomen, softer stools, a rumbling stomach, and a feeling of fullness. In case of overdose, avoid the intake of carbohydrate-containing food or drinks for the next 4-6 hours and seek medical advice immediately. If you forget to take Diastabol If you forget to take one or more doses of Diastabol do not take the tablets between meals but, instead, wait until your next scheduled dose and continue as before. Do not take a double dose to make up for a forgotten tablet. 4. POSSIBLE SIDE EFFECTS Like all medicines, Diastabol can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data). You may experience one or more gastro-intestinal symptoms whilst taking Diastabol: - Very common side effects: Flatulence (wind). Diarrhoea. Abdominal pain. - Common side effects: Nausea (feeling sick). Constipation. Dyspepsia (indigestion). Normally, these side effects usually disappear when treatment is continued. They may be reduced if you keep to your prescribed diet and avoid sugar or sucrose-containing foods. If your symptoms persist for more than two or three days, consult your doctor, particularly in the case of diarrhoea. Common side effects: if Diastabol is taken in combination with other treatments for diabetes, for example sulfonylureas and insulin, you may experience a low blood sugar level (hypoglycaemia). Other side effects include: - Common side effects: Increased liver enzymes - Uncommon side effects: Abnormal liver function If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE DIASTABOL 4

5 Keep out of the reach and sight of children. Do not use Diastabol after the expiry date which is stated on the outer cardboard box and the blisters. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Diastabol contains - The active substance is miglitol. Each tablet contains 50 mg miglitol. - The other ingredients are: microcrystalline cellulose, magnesium stearate, maize starch. What Diastabol looks like and contents of the pack Diastabol 50 mg are supplied to you as white to slightly pale yellow, round biconvex tablets. They are blank on one side and imprinted with MIG 50 on the other side. The tablets are provided in blister packs containing 15, 20, 30, 50, 60, 90, 120 or 240 tablets. Not all pack sizes may be marketed. Other strengths available: Diastabol 100 mg tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Manufacturer: Bayer Schering Pharma AG, Leverkusen, Germany. This leaflet was last approved in 5