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Λογότυπο Γαληνού

SPC, UK: Glucobay 50mg tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Bayer plc
Διεύθυνση :
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
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Name of the medicinal product

Glucobay 50 mg tablets

Qualitative and quantitative composition

Glucobay 50 mg tablets: 1 tablet contains 50 mg acarbose.

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

Glucobay 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 ...

Contraindications

Hypersensitivity to acarbose or any of the excipients, pregnancy and in nursing mothers. Glucobay is also contra-indicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal ...

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

In all species tested, acarbose exerts its activity in the intestinal tract. The action of acarbose is based on the competitive inhibition of intestinal enzymes (α-glucosidases) involved in the degradation ...

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 > 10g/kg body-weight. Intravenous LD<sub>50</sub> values ranged from 3.8g/kg ...

List of excipients

Glucobay tablets contain the following excipients: Microcrystalline cellulose Silica, colloidal anhydrous Magnesium stearate Maize starch

Incompatibilities

None stated.

Shelf life

36 months.

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 Bayer House Strawberry Hill Newbury Berkshire RG14 1JA

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

26 April 2012
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