Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
ACARBOSE
Multigeneris GmbH
ACARBOSE
50 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2014-01-31
1 PACKAGE LEAFLET: INFORMATION FOR THE USERAcarbose 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 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. WHAT IS IN THIS LEAFLET 1. What Přečtěte si celý dokumentis and what it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR Acarbose is used in the treatment of non-insulin dependent diabetes mellitus in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents. This medicine has been prescribed for you by your doctor to treat your diabetes. Acarbose will help to control your blood sugar levels. This is because Acarbose 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE - if you are allergic to acarbose or any of the other ingredients of this medicine (listed in section 6). If you are unsure about this ask your doctor. - if you suffer from inflammation or ulceration of the bowel, e.g. ulcerative colitis or Crohn's disease. - if you have, or are susceptible to, an obstruction in your intestines. - if you have a liver disorder. - if you have an intestin
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acarbose Tecnimede 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of Acarbose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, circular, plain tablets, scored on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acarbose is recommended for the treatment of type II diabetes mellitus in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Acarbose 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. 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. Adults The recommended initial dose is 50 mg three times a day. However, some patients may benefit from more gradual initial dose titration to minimise gastrointestinal side effects. This may be achieved by initiating treatment at 50 mg once or twice a day, with subsequent titration to a three times a day regimen. If after six to eight weeks' treatment patients show an inadequate clinical response, the dosage may be increased to 100 mg three times a day. A further increase in dosage to a maximum of 200 mg three times a day may occasionally be necessary. Patients receiving the maximum dose _require careful monitoring (see Special warnings and precautions for use, Section 4.4)._ Acarbose is intended for continuous long-term tre Přečtěte si celý dokument