GLIMEPIRIDE Tablet (2014)
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Περιεχόμενα
Name of the medicinal product
Glimepiride 1 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 1 mg of glimepiride. Each tablet contains 78.37 mg of lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Glimepiride Tablets 1 mg: Pink coloured round, flat uncoated tablets with bevelled edges and score line one side & plain on other side. The score line is only to facilitate breaking for ease of ...
Therapeutic indications
Glimepiride is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate.
Posology and method of administration
For oral administration. The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin cannot compensate if ...
Contraindications
Glimepiride is contraindicated in patients with the following conditions: Hypersensitivity to glimepiride, other sulfonylureas or sulfonamides or to any of the excipients listed in section 6.1. Insulin ...
Special warnings and precautions for use
Glimepiride must be taken shortly before or during a meal. When meals are taken at irregular hours or skipped altogether, treatment with Glimepiride Tablets may lead to hypoglycaemia. Possible symptoms ...
Interaction with other medicinal products and other forms of interaction
f glimepiride is taken simultaneously with certain other medicinal products, both undesired increases and decreases in the hypoglycaemic action of glimepiride can occur. For this reason, other medicinal ...
Pregnancy and lactation
Pregnancy Risk related to the diabetes Abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities and perinatal mortality. So the blood glucose level ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. The patients ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, ...
Undesirable effects
The following adverse reactions from clinical investigations were based on experience with glimepiride and other sulfonylureas, were listed below by system organ class and in order of decreasing incidence ...
Overdose
Symptoms After ingestion of an overdosage hypoglycaemia may occur, lasting from 12 to 72 hours, and may recur after an initial recovery. Symptoms may not be present for up to 24 hours after ingestion. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Blood glucose lowering drugs, excl. insulins: Sulfonamides, urea derivatives ATC Code: A10BB12 Glimepiride is an orally active hypoglycaemic substance belonging to the sulphonylurea ...
Pharmacokinetic properties
Absorption The bioavailability of glimepiride after oral administration is complete. Food intake has no relevant influence on absorption, only the absorption rate is slightly diminished. Maximum serum ...
Preclinical safety data
Preclinical effects observed occurred at exposures sufficiently in excess of the maximum human exposure as to indicate little relevance to clinical use, or were due to the pharmacodynamic action (hypoglycaemia) ...
List of excipients
Lactose monohydrate Sodium starch glycolate (type A) Povidone K-30 Magnesium stearate Iron oxide red (E172)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Keep the blister in the outer carton.
Nature and contents of container
The blisters, of PVC/PVdC, are heat sealed with hard tempered aluminium foil and packaged in a carton with a pack insert. PVC/PVdC/Aluminium blisters are clear/transparent. Pack sizes: 10, 30, 60, 90, ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0087
Date of first authorization / renewal of the authorization
27/11/2008
Date of revision of the text
24/07/2014
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