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Europe — EMA

Glucophage

Glucophage (metformin hydrochloride) is a prescription oral antidiabetic used in the EU to manage type 2 diabetes; learn uses, side effects, precautions, and interactions.

Metformin Hydrochloride

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What is Metformin Hydrochloride?

Glucophage is a prescription medication whose active ingredient is metformin hydrochloride, a biguanide antidiabetic agent. While the specific dosage strength and dosage form are not detailed in this entry, Glucophage is administered orally and is marketed in the European Union. It belongs to the therapeutic class of antidiabetic drugs and is primarily used to improve blood glucose control in adults with type 2 diabetes mellitus.

What is Metformin Hydrochloride used for?

Glucophage is indicated for the management of hyperglycemia in patients with type 2 diabetes mellitus, often as part of a comprehensive treatment plan that includes diet and exercise.

- As monotherapy in patients newly diagnosed with type 2 diabetes. - In combination with other oral antidiabetic agents when glycemic control is insufficient. - As adjunct to insulin therapy for patients requiring additional glucose lowering. - To improve insulin sensitivity and reduce hepatic glucose output. - For patients with overweight or obesity where weight-neutral therapy is desired.

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, or diarrhea. - Metallic taste in the mouth. - Decreased appetite or mild weight loss. - Vitamin B12 deficiency with long‑term use. - Headache or dizziness. - Fatigue or malaise.

Serious: - Lactic acidosis, a rare but potentially life‑threatening condition. - Severe skin reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis.

What precautions apply to Metformin Hydrochloride?

Before initiating Glucophage, healthcare providers assess several clinical factors to minimize risks and ensure appropriate use.

- Evaluate renal function; contraindicated in severe renal impairment. - Review hepatic status, as liver disease may increase lactic acidosis risk. - Assess for conditions that predispose to hypoxia, such as heart failure or recent myocardial infarction. - Use caution in elderly patients due to altered drug clearance. - Monitor vitamin B12 levels during long‑term therapy. - Discontinue before any radiographic studies using iodinated contrast agents.

What does Metformin Hydrochloride interact with?

Glucophage can interact with other medicines, affecting its efficacy or safety.

Avoid: - Iodinated contrast media used for imaging studies. - Cimetidine, which may increase metformin plasma concentrations. - Alcohol excess, which can raise the risk of lactic acidosis.

Use with caution: - Certain diuretics that may impair renal function. - ACE inhibitors or ARBs, especially in patients with renal insufficiency. - Beta‑blockers, as they may mask hypoglycemia symptoms.

Frequently asked questions

What is the mechanism of action of Glucophage in type 2 diabetes?+
Glucophage contains metformin hydrochloride, which reduces hepatic glucose production and increases peripheral insulin sensitivity, helping lower blood glucose levels.
Can Glucophage be used in patients with kidney disease?+
Glucophage is contraindicated in severe renal impairment; dosage adjustment or alternative therapy may be needed for patients with moderate renal dysfunction.
Is it safe to take Glucophage during pregnancy?+
The pregnancy category for Glucophage is not clearly defined; clinicians weigh potential benefits against risks and may consider alternative treatments.
What are the most common gastrointestinal side effects of Glucophage?+
Typical GI side effects include nausea, abdominal discomfort, diarrhea, metallic taste, and occasional loss of appetite.
How should Glucophage be taken to reduce stomach upset?+
It is usually recommended to take Glucophage with meals and to start with a low dose that is gradually increased as tolerated.
What monitoring is required while on Glucophage therapy?+
Regular monitoring of renal function, liver enzymes, blood glucose, and vitamin B12 levels during long‑term use is advised.
Can Glucophage cause weight loss?+
Metformin may lead to modest weight loss in some patients, primarily due to decreased appetite and improved insulin sensitivity.
What should I do if I miss a dose of Glucophage?+
Take the missed dose as soon as you remember unless it is close to the time of the next scheduled dose; do not double‑dose.
Why is lactic acidosis a concern with Glucophage?+
Lactic acidosis is a rare but serious condition that can occur when metformin accumulates, especially in patients with impaired kidney or liver function or conditions causing hypoxia.
Are there any dietary restrictions while taking Glucophage?+
No specific diet is required, but limiting excessive alcohol intake and maintaining a balanced diet support optimal blood glucose control.
How does Glucophage interact with insulin therapy?+
Glucophage can be combined with insulin to improve glycemic control, but dose adjustments of insulin may be necessary to avoid hypoglycemia.
What should be done before undergoing imaging with iodinated contrast?+
Glucophage should be temporarily discontinued before and after the procedure, as contrast agents can affect kidney function and increase the risk of lactic acidosis.
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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