GLUCOPHAGE Film-coated tablet (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

GLUCOPHAGE 500 mg film-coated tablets. GLUCOPHAGE 850 mg film-coated tablets.

2. Qualitative and quantitative composition

Glucophage 500 mg: One film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base. Glucophage 850 mg: One film-coated tablet contains 850 mg metformin ...

3. Pharmaceutical form

Film-coated tablet. Glucophage 500 mg: White, circular, convex film-coated tablets 11 mm in diameter and 5.7 mm high, engraved with GL 500. Glucophage 850 mg: White, circular, convex film-coated ...

4.1. Therapeutic indications

Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. In adults, Glucophage may be used as ...

4.2. Posology and method of administration

Posology Adults with normal renal function (GFR ≥90 mL/min) Monotherapy and combination with other oral antidiabetic agents The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2 or 3 times ...

4.3. Contraindications

Hypersensitivity to metformin or to any of the excipients listed in section 6.1. Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis). Diabetic pre-coma. Severe renal failure ...

4.4. Special warnings and precautions for use

Lactic acidosis Lactic acidosis, a very rare, but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis. Metformin accumulation occurs ...

4.5. Interaction with other medicinal products and other forms of interaction

Concomitant use not recommended Alcohol Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic impairment. Iodinated contrast ...

4.6. Fertility, pregnancy and lactation

Pregnancy Uncontrolled hyperglycaemia in the periconceptional phase and during pregnancy is associated with increased risk of congenital abnormalities, pregnancy loss, pregnancy-induced hypertension, preeclampsia, ...

4.7. Effects on ability to drive and use machines

Metformin monotherapy does not cause hypoglycaemia and therefore has no effect on the ability to drive or to use machines. However, patients should be alerted to the risk of hypoglycaemia when metformin ...

4.8. Undesirable effects

During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite which resolve spontaneously in most cases. To prevent them, it is recommended ...

4.9. Overdose

Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks may lead to ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Blood glucose lowering drugs. Biguanides; ATC code: A10BA02 Mechanism of action Metformin is a biguanide with antihyperglycaemic effects, on both basal and postprandial ...

5.2. Pharmacokinetic properties

Absorption After an oral dose of metformin hydrochloride tablet, maximum plasma concentration (Cmax) is reached in approximately 2.5 hours (tmax). Absolute bioavailability of a 500 ...

5.3. Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies on safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity.

6.1. List of excipients

Tablet core: Povidone K 30 Magnesium stearate Film-coating: Hypromellose

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

500 mg tablets 1 (x100), 9, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 200, 500, 600 or 1000 tablets in blister packs (PVC-aluminium) 21, 30, 40, 50, 60, 100, 120, 300, 400, 500, 600 or 1000 tablets ...

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Merck Serono Limited, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK

8. Marketing authorization number(s)

PL 11648/0085-86

9. Date of first authorization / renewal of the authorization

17 January 2015

10. Date of revision of the text

September 2022

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