Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ACARBOSE
Multigeneris GmbH
100 Milligram
Tablets
2012-01-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acarbose Tecnimede 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of Acarbose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, plain, round 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 100 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 100 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 tr Read the complete document