GLYFORMIN Film-coated tablet (2018)

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Περιεχόμενα

1. Name of the medicinal product

Glyformin 500 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 500 mg metformin hydrochloride. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet. White to off white, round, biconvex film-coated tablets, embossed with MET 500 on one side and plain on the other side.

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, Glyformin 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 hydrochloride 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. ...

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 cases of fasting, malnutrition or hepatic impairment. Iodinated contrast ...

4.6. Fertility, pregnancy and lactation

Pregnancy Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with increased risk of congenital abnormalities and perinatal mortality. A limited amount of data from the use ...

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 85g, although lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks of metformin ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, Blood glucose lowering drugs, excl. insulins ATC code: A10BA02 Mechanism of action Metformin is a biguanide with antihyperglycaemic effects, ...

5.2. Pharmacokinetic properties

Absorption After an oral dose of metformin hydrochloride tablet, maximum plasma concentration (Cmax) is reached in 2.5 hours (tmax). Absolute bioavailability of a 500mg or 850mg metformin ...

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

Core: Povidone Cellulose, microcrystalline Glycerol Silica, colloidal anhydrous Magnesium Stearate Coating: Hypromellose Macrogol 400 Titanium Dioxide Talc

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light and moisture.

6.5. Nature and contents of container

PVC/Aluminium blisters. Pack-size of 100 film-coated tablets. PP containers with PE closure. Pack-sizes of 100, 500 and 1000 film-coated tablets. Not all pack-sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

9028

9. Date of first authorization / renewal of the authorization

Date of first authorization: 15 September 1983 Date of latest renewal: 13 May 2009

10. Date of revision of the text

28/8/2018

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