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Europe — EMA

Glucophage

Glucophage (metformin hydrochloride) is an oral antidiabetic drug for type 2 diabetes. Learn its uses, side effects, precautions, and drug interactions.

Metformin Hydrochloride

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What is Metformin Hydrochloride?

Glucophage is a prescription medication that contains the active ingredient metformin hydrochloride, a biguanide oral antidiabetic agent. It is marketed in the European Union and is supplied in tablet form, though specific strengths may vary by product. Glucophage works by decreasing hepatic glucose production and improving peripheral insulin sensitivity, helping to lower elevated blood glucose levels in patients with type 2 diabetes mellitus as part of a comprehensive treatment plan.

What is Metformin Hydrochloride used for?

Glucophage is indicated for the management of type 2 diabetes mellitus, typically as part of a broader therapeutic regimen that includes diet and exercise.

- Improves glycemic control in adults with type 2 diabetes. - May be used as initial monotherapy when lifestyle changes are insufficient. - Can be combined with other oral antidiabetic agents or insulin to achieve target blood glucose levels. - May be considered in patients with overweight or obesity to aid weight management as an adjunct to lifestyle measures. - Used off‑label in some regions for polycystic ovary syndrome under medical supervision.

What are the side effects of Metformin Hydrochloride?

The safety profile of Glucophage includes a range of adverse effects that vary in frequency and severity.

Common: - Gastrointestinal upset such as nausea, abdominal discomfort, and diarrhea, which often improve with dose titration. - A metallic taste in the mouth that may be transient. - Decreased appetite or mild weight loss, particularly during the initial weeks of therapy.

Serious: - Lactic acidosis, a rare but potentially life‑threatening condition characterized by rapid breathing, muscle pain, and abdominal discomfort. - Severe hypoglycemia when Glucophage is combined with insulin or sulfonylureas, requiring careful monitoring of blood glucose. - Hepatotoxicity presenting as elevated liver enzymes or jaundice, especially in patients with pre‑existing liver disease. - Vitamin B12 deficiency with prolonged use, which may lead to anemia or peripheral neuropathy.

What precautions apply to Metformin Hydrochloride?

When prescribing Glucophage, clinicians consider several precautionary measures to minimize risk and ensure safe use.

- Assess renal function before initiation and periodically thereafter, as reduced clearance increases the risk of accumulation. - Avoid use in patients with known hypersensitivity to metformin or other biguanides. - Use with caution in individuals with hepatic impairment, heart failure, or conditions predisposing to hypoxia. - Discontinue the drug prior to any radiographic studies involving iodinated contrast agents. - Monitor for signs of lactic acidosis, especially in the elderly or those with comorbidities. - Evaluate vitamin B12 levels during long‑term therapy and supplement if deficiency is detected.

What does Metformin Hydrochloride interact with?

Glucophage may interact with other medicines, affecting its efficacy or increasing the risk of adverse events.

Avoid: - Iodinated contrast agents used for imaging studies; they can precipitate acute renal failure when combined with metformin. - Certain cimetidine formulations that significantly reduce metformin clearance. - Renal tubular secretion inhibitors such as probenecid, which may increase metformin plasma concentrations.

Use with caution: - Insulin and sulfonylureas, which may increase the risk of hypoglycemia. - Diuretics that can affect renal function and alter metformin levels. - Corticosteroids, which may raise blood glucose and require dose adjustments. - Alcohol excess, which can potentiate lactic acidosis. - Beta‑blockers, which can mask hypoglycemia symptoms and affect glucose control. - Thyroid hormones, which may alter glucose metabolism and require monitoring.

Frequently asked questions

What is the mechanism of action of Glucophage in type 2 diabetes?+
Glucophage (metformin) reduces hepatic glucose production and increases peripheral insulin sensitivity, which helps lower blood glucose levels in patients with type 2 diabetes.
Can Glucophage be used as the first‑line treatment for type 2 diabetes?+
Metformin is commonly recommended as an initial oral therapy for type 2 diabetes when diet and exercise alone do not achieve glycemic targets.
What are the most frequently reported gastrointestinal side effects of Glucophage?+
Common gastrointestinal effects include nausea, abdominal discomfort, diarrhea, a metallic taste, and mild weight loss, especially during the early weeks of treatment.
How should Glucophage be managed before undergoing imaging with iodinated contrast?+
The medication should be discontinued at the time of the contrast study and resumed only after renal function has been reassessed, to reduce the risk of acute kidney injury.
Is it safe to take Glucophage if I have mild kidney impairment?+
Renal function should be evaluated before starting Glucophage and monitored regularly; dose adjustments or alternative therapy may be needed if kidney function declines.
What signs indicate a possible lactic acidosis while on Glucophage?+
Symptoms such as rapid breathing, muscle pain, abdominal discomfort, dizziness, or unexplained fatigue warrant immediate medical evaluation for lactic acidosis.
Can Glucophage cause vitamin B12 deficiency?+
Long‑term use of metformin has been associated with reduced vitamin B12 absorption; periodic monitoring of B12 levels is recommended.
Should I avoid alcohol while taking Glucophage?+
Excessive alcohol intake can increase the risk of lactic acidosis and should be limited while on metformin therapy.
How does Glucophage interact with insulin therapy?+
When combined with insulin or sulfonylureas, Glucophage may increase the risk of hypoglycemia, so blood glucose should be closely monitored.
Is Glucophage safe to use during pregnancy?+
The safety of metformin in pregnancy should be evaluated by a healthcare professional; it may be prescribed when the benefits outweigh potential risks.
Can Glucophage be used in patients with heart failure?+
Metformin can be used in stable heart failure, but caution is advised, and renal function should be closely monitored.
What monitoring is recommended for patients on long‑term Glucophage therapy?+
Regular assessment of renal function, liver enzymes, blood glucose, and vitamin B12 levels is recommended during prolonged treatment.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Metformin Hydrochloride
Route
Oral Use
Manufacturer
Merck Santé S.A.S.
Origin
EU

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