GLYFORMIN/METFORMIN

Adults:

Usually one 500mg tablet 3 times a day to be taken with meals. Should control of diabetes be incomplete a gradual increase in dosage to a maximum of 3g daily in divided doses taken together with meals may be instituted This dosage regimen should not be increased above 3g.

Children:

Not recommended Elderly: Metformin, while indicated in the elderly should not be used when renal function is impaired Route of adminstration: Oral

While Glyformin is usually well tolerated, gastro-intestinal disturbances sometimes occur and although they are usually minor they can normally be avoided by taking Glyformin with or after food. It may, however, be necessary temporarily to lower the dose of Glyformin.

Glyformin treatment should not be abandoned at the first sign of intolerance because this has been found to resolve spontaneously. 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 to take metformin in 2 or 3 daily doses and to increase slowly the doses. The following adverse reactions may occur under treatment with metformin. Frequencies are defined as follows: very common: ≥1/10; common >1/100, <1/10; uncommon >1/1,000, <1/100; rare >1/10,000, <1/1,000; very rare <1/10,000.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4). 4). Lactic acidosis has been associated with Glyformin, but in the rare cases reported it has occurred in patients with contraindications to therapy.

In patients with a metabolic acidosis lacking evidence of ketoacidosis (ketoneuria and ketonaemia )lactic acidosis should be suspected and Glyformin therapy stopped. Lactic acidosis is a medical emergency which must be treated in hospital.

Nervous system disorders Common:

Taste disturbance Gastrointestinal disorders Very common: Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases.

To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

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 at acute worsening of renal function and increases the risk of lactic acidosis.

In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), metformin should be temporarily discontinued and contact with a health care professional is recommended. Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and NSAIDs) should be initiated with caution in metformin-treated patients.

5). Patients and/or care-givers should be informed of the risk of lactic acidosis. Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma. In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.

35), increased plasma lactate levels (>5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.

Patients with known or suspected mitochondrial diseases:

In patients with known mitochondrial diseases such as Mitochondrial Encephalopathy with Lactic Acidosis, and Stroke-like episodes (MELAS) syndrome and Maternal inherited diabetes and deafness (MIDD), metformin is not recommended due to the risk of lactic acidosis exacerbation and neurologic complications which may lead to worsening of the disease.

In case of signs and symptoms suggestive of MELAS syndrome or MIDD after the intake of metformin, treatment with metformin should be withdrawn immediately and prompt diagnostic evaluation should be performed. 2. 3. Cardiac function Patients with heart failure are more at risk of hypoxia and renal insufficiency.

In patients with stable chronic heart failure, metformin may be used with a regular monitoring of cardiac and renal function. 3). Administration of iodinated contrast agents Glyformin should not be used: in conditions which may cause dehydration.

1. The drug is contraindicated in diabetic coma and ketoacidosis. Chronic liver disease. Impaired renal function. Cardiac failure. Recent myocardial infarction. Shock or pulmonary insufficiency and conditions associated with lactic acidosis.

Acute or chronic alcoholism. Those conditions associated with hypoxaemia. Acute conditions with the potential to alter renal function such as: severe infection or trauma, dehydration. Peripheral vascular disease. Hypersensitivity to the drug.

Severe renal failure (GFR < 30 mL/min).