METFORMIN DENK 500 Tablet

Metformin Denk 500 belongs to a group of drugs used in the treatment of non-insulin dependent type 2 diabetes mellitus in adults and in children starting from 10 years of age.

Metformin Denk 50 is a drug used to lower elevated blood glucose levels in patients suffering from type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone do not result in adequate glycaemic control.

Adults: Metformin Denk 500 may be administered alone (monotherapy) or in combination with other oral anti-diabetic agents or with insulin.

Children from 10 years of age and adolescents: Metformin Denk 500 may be administered alone (monotherapy) or in combination with insulin.

A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin hydrochloride as first-line therapy after diet failure.

Dosage

See the package insert about the details.

Adults

The usual starting dose is 2-3 tablets a day given during or after meals.

This dose may be increased to a maximum of 6 tablets a day.

However, a higher strength drug is recommended of several tablets are required.

Children starting from 10 years of age and adolescents (monotherapy and in combination with insulin):

The usual starting dose is 1 tablet daily taken during or after meals.

The daily dose may be increased to a maximum of 4 tablets.

Elderly patients

The dosage should be adjusted on the basis of renal function.

Mode of Administration

Swallow the film-coated tablets whole with sufficient fluids during or after meals.

If two or more film-coated tablets are required, these should be distributed throughout the day, e.g. 1 tablet during or after the breakfast and 1 during or after the evening meal.

- if you are allergic (hypersensitive) to metformin hydrochloride or any of the otter ingredients of Metformin Denk 500,

- if you suffer from diabetic over-acidification of the blood (diabetic acidosis), preliminary stage of coma,

- in case of renal failure or renal dysfunction,

- in cute conditions with the potential to impair renal function, such as

- fluid loss due to persistent vomiting or severe diarrhoea,

- severe infections,

- circulatory collapse (shock),

- intravenous administration of iodinated contrast materials in radiological investigations prior to, during and up to 48 hours after the examination,

- in case of acute or chronic disease which may result in oxygen deficiency to the body tissues, such as

- cardiac or respiratory failure,

- recent myocardial infarction

- circulatory collapse (shock),

- hepatic insufficiency, acute alcohol intoxication, alcoholism,

- breast-feeding.

Gastrointestinal disorders

Very common: nausea, vomiting, diarrhoea, tummy-ache, loss of appetite. These usually occur at the onset of therapy and mostly disappear spontaneously. Metformin Denk 500 should be taken with or after meals in 2-3 single doses in order to avoid these complaints. Stop taking Metformin Denk 500 if these symptoms persist and speak to your doctor.

Metabolic and nutritional disorders

Very rare: severe metabolic decompensation manifested by over-acidification of the blood with lactic acid (lactic acidosis). This may be manifested by vomiting, tummy-ache, muscular pain, cramps as well as severe general lassitude.

Very rare: decrease of vitamin B12 absorption with subsequent decrease of serum levels. Consideration of such aetiology is recommended in patients with a certain type of anaemia (megaloblastic anemia).

Nervous system disorders

Common: abnormal taste.

Skin and subcutaneous tissue disorders

Very rare: redness of the skin, itching, hives.

Hepatobiliary disorders

Very rare: liver function test abnormalities or inflammation of the liver (hepatitis) with or without jaundice resolving upon discontinuation of Metformin Denk 500.

See the package insert about the details below:

corticosteroids, certain medication to treat high blood pressure (ACE inhibitors), diuretics, certain medication used in the treatment of bronchial asthma (beta-sympathomimetic agents) as well as iodinated contrast materials or medicines containing alcohol.

Pregnancy

Contraindicated,

Insulin should be used in such cases to maintain blood glucose levels as close to normal as possible.

Lactation

Contraindicated.

Undesirable metformin accumulation may trigger or favour over-acidification of the blood with lactic acid (lactic acidosis). This is a complication that may have serious and life-threatening consequences, such as coma, in the absence of prompt treatment. Lactic acidosis occurs due to overdosing or a disregard for the presence or development of contraindications. Contraindications should therefore be strictly observed.

Signs of commencing lactic acidosis may resemble gastrointestinal side effects of metformin: nausea, vomiting, diarrhoea and tummy-ache Full manifestation of lactic acidosis including muscular pain and cramps, increased respiration as well as semi-consciousness and coma may develop within hours, requiring immediate emergency treatment in a hospital.

The danger of undesired metformin accumulation and thus the risk of over-acidification of the blood (lactic acidosis) is dependent on renal function in particular. This is why normal renal function is a prerequisite for therapy with Metformin Denk 500.

Your renal function should therefore be assessed at least annually by determining serum creatinine levels, and more often if required. If your serum creatinine is at the upper limit of normal, you should get your serum creatinine checked at least 2-4 times a year. One should bear in mind that measuring serum creatinine alone is not always sufficient, particularly in elderly patients. If required, creatinine clearance, another means of assessing renal function, should be determined prior to the initiation of therapy.

Particular caution should be exercised in situations which have the potential to impair renal function (e.g. at the commencement of therapy with certain drugs used in the treatment of high blood pressure or rheumatic disease).

Particular caution is also advised in cases of liver dysfunction.

Intravenous administration of iodinated contrast materials in radiological investigations can lead to acute renal failure. Treatment with Metformin Denk 500 must therefore be discontinued 2 days prior to the test and not be reinstituted until 2 days afterwards, and only after renal function has been reevaluated and found to be normal.

Inform your doctor if you develop a bacterial or viral infection (flu, respiratory or urinary tract infection, for example).

Continue your diet during therapy with Metformin Denk 500 ensuring a regular distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet under medical supervision.

A high alcohol intake is associated with the risk of hypoglycaemia and lactic acidosis. Alcohol should therefore be avoided during treatment with metformin hydrochloride.

See the package insert about the details below: Use in children and adolescents.