Europe — EMA
Oramet (Metformin Hydrochloride)
Metformin Hydrochloride, the active ingredient in Oramet, is a biguanide presented as a 500 mg tablet for oral use. It treats type 2 diabetes mellitus in adults and adolescents.
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What is Metformin Hydrochloride?
Metformin Hydrochloride, the active ingredient in Oramet, is a biguanide presented as a 500 mg tablet for oral use. It treats type 2 diabetes mellitus in adults and adolescents. GNH USA supplies Oramet as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
GNH USA supplies Oramet as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Metformin Hydrochloride used for?
Oramet is a biguanide that improves glycaemic control in patients with disorders of glucose metabolism.
- Type 2 diabetes mellitus: lowers fasting and post‑prandial blood glucose levels. - Prediabetes: helps delay progression to overt diabetes when combined with lifestyle measures. - Polycystic ovary syndrome (PCOS): may improve insulin resistance and assist with menstrual regularity.
What are the side effects of Metformin Hydrochloride?
Metformin is generally well tolerated, but several adverse reactions have been reported.
Common Side Effects: - Diarrhoea: mild to moderate watery stools. - Nausea: occasional queasy feeling. - Abdominal discomfort: cramping or bloating. - Metallic taste: transient metallic sensation in the mouth. - Loss of appetite: reduced desire to eat. - Vitamin B12 deficiency: reduced levels with long‑term use.
Serious or Rare Side Effects: - Lactic acidosis: severe metabolic acidosis with high lactate levels. - Severe hypoglycaemia: usually when combined with insulin or sulfonylureas. - Hepatotoxicity: elevated liver enzymes indicating liver injury. - Severe skin reactions: such as Stevens‑Johnson syndrome. - Acute pancreatitis: inflammation of the pancreas. - Anaphylactic reaction: rare systemic allergic response.
What precautions apply to Metformin Hydrochloride?
Metformin should be used with careful clinical monitoring and patient education.
- Renal function assessment: evaluate glomerular filtration rate before initiation and periodically thereafter. - Hepatic function monitoring: check liver enzymes in patients with existing liver disease. - Cardiovascular status: use cautiously in patients with unstable heart failure. - Concomitant alcohol use: advise limiting intake to reduce lactic acidosis risk. - Surgical procedures: withhold before major surgery or radiographic contrast studies. - Store at below 25°C: keep in the original container, protect from moisture and light.
What does Metformin Hydrochloride interact with?
Metformin interacts with several medicines that can affect its safety or efficacy.
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