Metformin Hydrochioride Extended Release Tablets USP 500 mg

Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with Impaired Glucose Tolerance and/or Impaired Fasting Glucose, and/or increased HbA1C who are:
at high risk for developing overt type 2 diabetes mellitus and
still progressing towards type 2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months.
Treatment with Metfinox-SR must be based on a risk score incorporating appropriate measures of glycaemic control and including evidence of high cardiovascular risk. Lifestyle modifications should be continued when metformin is initiated, unless the patient is unable to do so because of medical reasons.
Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Metfinox-SR may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Adults with normal renal function (GFR ≥ 90 mL/min)
Reduction in the risk or delay of the onset of type 2 diabetes:
• Metformin should only be considered where intensive lifestyle modifications for 3 to 6 months have not resulted in adequate glycaemic control.
• The therapy should be initiated with one tablet Metfinox-SR 500 mg once daily with the evening meal.
• After 10 to 15 days dose adjustment on the basis of blood glucose measurements is recommended (OGTT and/or FPG and/or HbA1C values to be within the normal range). A slow increase of dose may improve gastro-intestinal tolerability.
The maximum recommended dose is 4 tablets (2000 mg) once daily with the evening meal.
• It is recommended to regularly monitor (every 3-6 months) the glycaemic status (OGTT and/or FPG and/or HbA1c value) as well as the risk factors to evaluate whether treatment needs to be continued, modified or discontinued.
• A decision to re-evaluate therapy is also required if the patient subsequently implements improvements to diet and/or exercise, or if changes to the medical condition will allow increased lifestyle interventions to be possible.
Monotherapy in Type 2 diabetes mellitus and combination with other oral antidiabetic agents:
• The usual starting dose is one tablet of Metfinox-SR 500 mg once daily.
• After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastro-intestinal tolerability. The maximum recommended dose is 4 tablets daily.
Combination with insulin:
Metformin and insulin may be used in combination therapy to achieve better blood glucose control. The usual starting dose of Metfinox-SR is one 500 mg tablet once daily, 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. Regular assessment of renal function is necessary.
Benefit in the reduction of risk or delay of the onset of type 2 diabetes mellitus has not been established in patients 75 years and older and metformin initiation is therefore not recommended in these patients.

Taste disturbance, 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.

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.
Renal function: GFR should be assessed before treatment initiation and regularly thereafter, Metformin is contraindicated in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
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. For patients with acute and unstable heart failure, metformin is contraindicated.
Surgery: Metformin must be discontinued at the time of surgery under general, spinal or epidural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Other precautions:
All patients should continue their diet with a regular distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet.
The usual laboratory tests for diabetes monitoring should be performed regularly.
Metformin alone never causes hypoglycaemia, although caution is advised when it is used in combination with insulin or other oral antidiabetics (e.g. sulphonylureas or meglitinides).
The tablet shells may be present in the faeces. Patients should be advised that this is normal.

Store below 30oC preferably in cool and dry place. Protect from light and moisture.
Keep the medicine out of reach of children.

10 x 10 Alu/PVC blister pack
Metfinox-SR is available in an Alu/PVC blister of 10 tablets. Such 10 blisters in a unit carton with package insert.