Indication:

Indicated for management of Type II diabetes mellitus in adult patients when diet, exercise, and single agent (Glimepiride & metformin alone) do not result in adequate glycemic control.

During treatment with Glimy M, glucose levels in blood and urine must be measured regularly. Glimy M is to be administered once per day during breakfast or the first main meal. Glimy M must be swallowed whole and not crushed or chewed. The highest recommended dose per day should be 8mg of glimepiride and 2000mg of metformin. The starting dose of Glimy M should not exceed the daily doses of glimepiride or metformin already being taken. When switching from combination therapy of glimepiride plus metformin as separate tablets, Glimy M should be administered on the basis of dosage currently being taken. For higher doses, it may be necessary to divide the administration into 2 doses.

Children: Data insufficient to recommend pediatric use of Glimy M.

Renal impairment: A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin in patients with GFR<60 mL/min.

WARNINGS:

For Glimepride: In exceptional stress situations (e.g. trauma, surgery, febrile infections) blood glucose regulation may deteriorate, switch to insulin may be required.

For Metformin: 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. 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. Intravascular administration of iodinated contrast agents may lead to contrast induces, nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.

PRECAUTIONS:

For Glimepride: Risk of hypoglycaemia. Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to hemolytic anaemia.

For Metformin: Regular monitoring of thyroid- stimulating hormone (TSH) levels is recommended in patients with hypothyroidism. Long-term treatment with metformin has been associated with a decrease in vitamin B12 serum levels which may cause peripheral neuropathy. Monitoring of the vitamin B12 level is recommended

Therapeutic indication: As third line treatment of Type II diabetes mellitus in adult patients when diet, exercise, and the single agents and second line therapy with two drugs do not result in adequate glycemic control.

General: Usual recommended dose for adults: 1 tablet of Glimy MV twice a day before meals. Additionally, voglibose tablets may be taken before the remaining meal, as prescribed by the physician. Glimy MV must be swallowed whole and not crushed or chewed.

Children: Data insufficient to recommend pediatric use of Glimy MV.

Renal impairment: A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin in patients with GFR<60 mL/min. If no adequate strength of Glimy MV is available, individual mono-components should be used instead of the fixed dose combination.

WARNINGS:

For Glimepride: In exceptional stress situations (e.g. trauma, surgery, febrile infections) blood glucose regulation may deteriorate, switch to insulin may be required.

For Metformin: 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. 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. Intravascular administration of iodinated contrast agents may lead to contrast induces, nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis. Glimy MV to be discontinued at the time of imaging procedure and not restarted until at least 48 hours after provided that renal function is stable. Glimy MV must be discontinued at the time of surgery with general, spinal, or epidural anaesthesia.

PRECAUTIONS:

For Glimepride: Risk of hypoglycaemia. Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to hemolytic anaemia.

For Metformin: Regular monitoring of thyroid- stimulating hormone (TSH) levels is recommended in patients with hypothyroidism. Long-term treatment with metformin has been associated with a decrease in vitamin B12 serum levels which may cause peripheral neuropathy. Monitoring of the vitamin B12 level is recommended.

For Voglibose: Voglibose tablets should be administered with caution to the patients with history of laparotomy or ileus; patients with chronic intestinal disease accompanied by disturbance in digestion and absorption; patients with aggravating symptoms due to increased generation of intestinal gas (eg, Roemheld syndrome, severe hernia, and stenosis and ulcer of the large intestine) and patients with serious hepatic or renal disorders