GLICLAZIDE Tablet (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Gliclazide 40mg Tablets.
Qualitative and quantitative composition
Each tablet contains 40mg gliclazide. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White, circular, flat, bevelled-edge uncoated tablet plain on one face and the identifying letters GU on the reverse.
Therapeutic indications
Non insulin dependent diabetes mellitus.
Posology and method of administration
Posology Adults The total daily dose may vary from 40-320mg. The dose should be adjusted according to the individuals response, commencing with 40-80mg daily and increasing until adequate control is achieved. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, other sulfonylureas or sulfonamides. Type I diabetes. Diabetic pre-coma and coma, diabetic keto-acidosis. Severe ...
Special warnings and precautions for use
Hypoglycaemia This treatment should be prescribed only if the patient is likely to have a regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased ...
Interaction with other medicinal products and other forms of interaction
The following products are likely to increase the risk of hypoglycaemia Contraindicated combination Miconazole (systemic route, oromucosal gel): increases the hypoglycaemic effect with possible onset of ...
Pregnancy and lactation
Pregnancy For gliclazide, no clinical data on exposed pregnancies are available, even though there are few data with other sulfonylureas. Studies in animals have shown reproductive toxicity (see section ...
Effects on ability to drive and use machines
Gliclazide has no known influence on the ability to drive and use machines. However, patients should be informed that their concentration may be affected if their diabetes is not satisfactorily controlled, ...
Undesirable effects
Based on the experience with gliclazide, the following undesirable effects have to be mentioned. Hypoglycaemia As for other sulfonylureas, treatment with Gliclazide can cause hypoglycaemia, if mealtimes ...
Overdose
An overdose of sulfonylureas may cause hypoglycaemia. Moderate symptoms of hypoglycaemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment ...
Pharmacodynamic properties
Pharmacotherapeuticgroup: sulfonamides, urea derivatives ATC code: A10BB09 Gliclazide is a hypoglycaemic sulfonylurea antidiabetic active substance differing from other related compounds by an N-containing ...
Pharmacokinetic properties
The drug is well absorbed and its half-life in man is approximately 10-12 hours. Gliclazide is metabolised in the liver; less that 5% of the dose is excreted unchanged in the urine.
Preclinical safety data
Preclinical data reveal no special hazards for humans based on conventional studies of repeated dose toxicity and genotoxicity. Long term carcinogenicity studies have not been done. No teratogenic changes ...
List of excipients
Microcrystalline cellulose Pregelatinised starch Maize starch Stearic acid Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Blister packs of PVC with Aluminium foil containing 20, 28, 56, 60 84, 100 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0687
Date of first authorization / renewal of the authorization
15/03/2016
Date of revision of the text
25/07/2017
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