METFORMIN HYDROCHLORIDE CYGNUS PHARMA

Posology Adults with normal renal function (GFR≥ 90 mL/min) Monotherapy and combination with other oral antidiabetic agents: Metformin Prolonged-release Tablets 750 mg is intended for patients who are already treated with metformin tablets (prolonged or immediate release).

The dose of Metformin Prolonged-release Tablets 750 mg should be equivalent to the daily dose of metformin tablets (prolonged or immediate release), up to a maximum dose of 1500 mg given with the evening meal. After 10 to 15 days, it is recommended to check that the dose of Metformin Prolonged-release Tablets 750 mg is adequate on the basis of blood glucose measurements.

Combination with insulin For patients already treated with metformin and insulin in combination therapy, the dose of Metformin Prolonged-release Tablets 750 mg should be equivalent to the daily dose of metformin tablets, up to a maximum of 1500 mg given with the evening meal, while insulin dosage is adjusted on the basis of blood glucose measurements.

Elderly Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. 4). Renal impairment A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter.

g. every 3-6 months. GFR (mL/min) Total maximum daily dose Additional considerations 60-89 2000 mg Dose reduction may be considered in relation to declining renal function. 4) should be reviewed before considering initiation of metformin.

The starting dose is at most half of the maximum dose. <30 - Metformin is contraindicated. Paediatric population In the absence of available data, Metformin Prolonged-release Tablets should not be used in children. Method of administration For oral use Swallow the tablets whole with a glass of water.

Do not chew.

In post marketing data and in controlled clinical studies, adverse event reporting in patients treated with Metformin Prolonged-release Tablets was similar in nature and severity to that reported in patients treated with Metformin immediate release tablets.

During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite, which resolve spontaneously in most cases. The following adverse reactions may occur with Metformin Prolonged-release Tablets 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. Special warnings and precautions for use). Nervous system disorder 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. A slow increase of the dose may also improve gastrointestinal tolerability. Hepatobiliary disorders Very rare • Isolated reports of liver function tests abnormalities or hepatitis resolving upon metformin discontinuation Skin and subcutaneous tissue disorders Very rare: • Skin reactions such as erythema, pruritus, urticaria Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Lactic acidosis Lactic acidosis, a very rare, but serious metabolic complication, most often occurs at acute worsening of renal function or cardio respiratory 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. 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 Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis. 2 and

1. • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) • Diabetic pre-coma • Severe renal failure (GFR < 30 mL/min). • Acute conditions with the potential to alter renal function such as: • dehydration, • severe infection, • shock • Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: • decompensated heart failure, • respiratory failure, • recent myocardial infarction, • shock • Hepatic insufficiency, acute alcohol intoxication, alcoholism