GLUCOBAY 50mg Tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Glucobay 50 mg tablets.
Qualitative and quantitative composition
Glucobay 50 mg tablets: 1 tablet contains 50 mg acarbose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet for oral administration. White to yellow-tinged round, convex tablets of 7 mm diameter and 10 mm radius of curvature with G50 on one side and the BAYER-cross on the other side.
Therapeutic indications
Indications Glucobay is recommended for the treatment of non-insulin dependent (NIDDM) diabetes mellitus in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents. Mode ...
Posology and method of administration
Posology 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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, pregnancy and in nursing mothers. Glucobay is also contra-indicated in patients with inflammatory bowel disease, ...
Special warnings and precautions for use
Hypoglycaemia Glucobay has an antihyperglycaemic effect, but does not itself induce hypoglycaemia. If Glucobay is prescribed in addition to other blood glucose lowering drugs (e.g sulphonylureas metformin, ...
Interaction with other medicinal products and other forms of interaction
When administered alone, Glucobay does not cause hypoglycaemia. It may, however, act to potentiate the hypoglycaemic effects of insulin, metformin and sulphonylurea drugs, and the dosages of these agents ...
Pregnancy and lactation
Glucobay should not be administered during pregnancy as no information is available from clinical studies on its use in pregnant women. After the administration of radioactively marked acarbose to nursing ...
Effects on ability to drive and use machines
None known.
Undesirable effects
The frequencies of adverse drug reactions (ADRs) reported with Glucobay, based on placebo-controlled studies (Glucobay N=8,595; placebo N=7,278), are summarised in the table below. Within each frequency ...
Overdose
When Glucobay tablets are taken with drinks and/or meals containing carbohydrates overdose may lead to meteorism, flatulence and diarrhoea. If Glucobay tablets are taken in overdose independently of food, ...
Pharmacodynamic properties
Pharmacotherapeutic group: drugs used in diabetes, alpha-glusosidase inhibitors ATC code: A10BF01 In all species tested, acarbose exerts its activity in the intestinal tract. The action of acarbose is ...
Pharmacokinetic properties
Following administration, only 1-2% of the active inhibitor is absorbed. The pharmacokinetics of Glucobay were investigated after oral administration of the <sup>14</sup>C-labelled substance (200mg) to ...
Preclinical safety data
Acute toxicity LD<sub>50</sub> studies were performed in mice, rats and dogs. Oral LD<sub>50</sub> values were estimated to be >10 g/kg body-weight. Intravenous LD<sub>50</sub> values ranged from 3.8 g/kg ...
List of excipients
Glucobay tablets contain the following excipients: Microcrystalline cellulose Silica, colloidal anhydrous Magnesium stearate Maize starch
Incompatibilities
None stated.
Shelf life
Shelf life: 3 years.
Special precautions for storage
The tablets should be stored in the manufacturers original container in a dry place at temperatures below 25°C.
Nature and contents of container
Blister strips comprising 300μm polypropylene foil (colourless) with a 20μm soft aluminium backing foil, in cardboard outers. Pack sizes: 90.
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Marketing authorization number(s)
PL 00010/0171
Date of first authorization / renewal of the authorization
28 May 1993 / 16 February 2004
Date of revision of the text
31/08/2017
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