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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

REPAGLINIDE Tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Repaglinide 0.5 mg Tablets.

Qualitative and quantitative composition

Each tablet contains 0.5 mg of repaglinide. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. Repaglinde 0.5 mg Tablets are white, round, biconvex and engraved with RE on one side.

Therapeutic indications

Repaglinide is indicated in adults with type 2 diabetes mellitus whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in ...

Posology and method of administration

Posology Repaglinide is given preprandially and is titrated individually to optimise glycaemic control. In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient ...

Contraindications

Hypersensitivity to repaglinide or to any of the excipients listed in section 6.1. Diabetes mellitus type 1, C-peptide negative. Diabetic ketoacidosis, with or without coma. Severe hepatic function disorder. ...

Special warnings and precautions for use

General Repaglinide should only be prescribed if poor blood glucose control and symptoms of diabetes persist despite adequate attempts at dieting, exercise and weight reduction. Hypoglycaemia Repaglinide, ...

Interaction with other medicinal products and other forms of interaction

A number of medicinal products are known to influence repaglinide metabolism. Possible interactions should therefore be taken into account by the physician: In vitro data indicate that repaglinide is metabolised ...

Fertility, pregnancy and lactation

Pregnancy There are no studies of repaglinide in pregnant women. Repaglinide should be avoided during pregnancy. Breast-feeding There are no studies in breast-feeding women. Repaglinide should not be used ...

Effects on ability to drive and use machines

Repaglinide has no direct influence on the ability to drive and use machines but may cause hypoglycaemia. Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly ...

Undesirable effects

Summary of the safety profile The most frequently reported adverse reactions are changes in blood glucose levels, i.e. hypoglycaemia. The occurrence of such reactions depends on individual factors, such ...

Overdose

Repaglinide has been given with weekly escalating doses from 4-20 mg four times daily in a 6 week period. No safety concerns were raised. As hypoglycaemia in this study was avoided through increased calorie ...

Pharmacodynamic properties

Pharmaco-therapeutic group: Drugs used in diabetes, other blood glucose lowering drugs, excl. insulins ATC code: A10BX02 Mechanism of action Repaglinide is a short-acting oral secretagogue. Repaglinide ...

Pharmacokinetic properties

Absorption Repaglinide is rapidly absorbed from the gastrointestinal tract, which leads to a rapid increase in the plasma concentration of the active substance. The peak plasma level occurs within one ...

Preclinical safety data

Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. Repaglinide showed not to ...

List of excipients

Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Poloxamer Povidone Glycerol 85% Meglumine Polacrilin potassium Maize starch Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage precautions.

Nature and contents of container

Blisters (Aluminium/Aluminium). Pack sizes: 30, 60, 90, 100, 120 and 180 tablets Plastic (polyethylene) container with desiccant canister (filled with silica gel). Pack sizes: 100 tablets Not all pack ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Accord-UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization number(s)

PL 0142/1010

Date of first authorization / renewal of the authorization

09/04/2010 05/11/2015

Date of revision of the text

27/03/2019

Πηγαίο έγγραφο

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