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Europe — EMA

Glucophage

Glucophage (metformin hydrochloride) is an oral antidiabetic drug for type 2 diabetes, detailing 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. It is formulated as an oral tablet (strength and specific dosage form may vary) and is marketed in the European Union. As a member of the biguanide class, Glucophage is used to improve blood glucose control in adults with type 2 diabetes mellitus by decreasing hepatic glucose production and enhancing peripheral insulin sensitivity.

What is Metformin Hydrochloride used for?

Glucophage is indicated primarily for the management of type 2 diabetes mellitus in adults.

- Improves glycemic control as part of a comprehensive diabetes management plan that includes diet and exercise. - Can be used as monotherapy when metformin alone is sufficient to achieve target blood glucose levels. - May be combined with other oral antidiabetic agents or insulin when additional glucose lowering is needed. - Helps reduce the risk of diabetes‑related complications by maintaining more stable blood glucose concentrations. - Often prescribed for patients with overweight or obesity, as metformin may modestly aid weight management.

What are the side effects of Metformin Hydrochloride?

Side effects of Glucophage vary in frequency and severity; most are mild and transient, while rare reactions may require medical attention.

Common: - Gastrointestinal upset such as nausea, abdominal discomfort, or diarrhea. - Metallic taste in the mouth. - Decreased appetite. - Mild headache.

Serious: - Lactic acidosis, a rare but potentially life‑threatening condition characterized by rapid breathing, muscle pain, or unusual fatigue. - Severe skin reactions, including Stevens‑Johnson syndrome or toxic epidermal necrolysis. - Significant vitamin B12 deficiency with prolonged use.

What precautions apply to Metformin Hydrochloride?

Before starting Glucophage, certain health considerations and monitoring requirements should be reviewed with a healthcare professional.

- Assess renal function; metformin is contraindicated in severe renal impairment. - Evaluate liver function, as hepatic disease can increase the risk of lactic acidosis. - Use caution in patients with heart failure or a history of hypoxia. - Monitor blood glucose regularly to avoid hypoglycemia, especially when combined with other glucose‑lowering drugs. - Periodic assessment of vitamin B12 levels is recommended for long‑term therapy. - Discontinue before any radiographic studies that involve iodinated contrast agents.

What does Metformin Hydrochloride interact with?

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

Avoid: - Iodinated contrast agents used in imaging studies; they can precipitate acute kidney injury and increase lactic acidosis risk. - Certain cationic drugs (e.g., trimethoprim, pyrimethamine) that may reduce metformin clearance. - Alcohol excess, which can potentiate lactic acidosis.

Use with caution: - Other antidiabetic agents, especially sulfonylureas or insulin, due to increased hypoglycemia risk. - Diuretics that may affect renal function and metformin elimination. - Corticosteroids, which can raise blood glucose and alter metformin dosing needs.

Frequently asked questions

What is the mechanism of action of Glucophage (metformin hydrochloride)?+
Glucophage reduces hepatic glucose production and increases peripheral insulin sensitivity, helping lower blood sugar levels in type 2 diabetes.
How does Glucophage help control blood sugar in type 2 diabetes?+
By decreasing the amount of glucose produced by the liver and improving the response of muscle and fat cells to insulin, Glucophage assists in maintaining target blood glucose concentrations.
Can Glucophage be used in combination with insulin?+
Yes, Glucophage can be combined with insulin when additional glucose lowering is required, but dose adjustments and monitoring for hypoglycemia are recommended.
What are the most common gastrointestinal side effects of Glucophage?+
Common gastrointestinal effects include nausea, abdominal discomfort, diarrhea, and a metallic taste in the mouth.
How can I reduce the risk of nausea when starting Glucophage?+
Taking the medication with meals, starting at a low dose, and gradually titrating upward can help minimize nausea.
What signs indicate a serious reaction like lactic acidosis while taking Glucophage?+
Symptoms such as rapid breathing, muscle pain, unusual fatigue, abdominal discomfort, or a feeling of coldness may suggest lactic acidosis and require immediate medical attention.
Should I have my kidney function tested before taking Glucophage?+
Yes, renal function should be evaluated before initiating therapy and periodically thereafter, as impaired kidneys increase the risk of lactic acidosis.
Is it safe to drink alcohol while taking Glucophage?+
Alcohol can increase the risk of lactic acidosis; moderate consumption is advised, and excessive intake should be avoided.
How does Glucophage interact with iodinated contrast media used in imaging?+
Iodinated contrast agents can impair kidney function and raise the risk of lactic acidosis; Glucophage should be discontinued before the procedure and resumed only after renal function is confirmed normal.
Do I need regular vitamin B12 monitoring while on Glucophage?+
Long‑term use of metformin may reduce vitamin B12 absorption, so periodic monitoring is recommended, especially if neurological symptoms develop.
Can Glucophage be prescribed to pregnant women?+
The safety of Glucophage during pregnancy has not been fully established; prescribing decisions should be made by a healthcare provider based on individual risk‑benefit assessment.
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 the dose.
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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