Empamet XR 25/1000 

Presentation: Each extended-release tablet of Empamet XR 25/1000 contains Empagliflozin INN 25 mg and Metformin Hydrochloride BP 1000 mg.

Indications: Empamet XR is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control:

• In patients insufficiently controlled on their maximally tolerated dose of metformin alone.
• In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products.
• In patients already being treated with the combination of empagliflozin and metformin as separate tablets. The empagliflozin component of this product is also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

Dosage and Administration: The dosage should be individualized based on effectiveness and tolerability, not exceeding the maximum recommended daily dose of empagliflozin 25 mg and metformin 2000 mg. It is taken orally once daily with a meal, preferably in the evening. Dose escalation should be gradual to reduce the gastrointestinal side effects due to metformin.

• Initial Dose: In patients currently not treated with metformin, initiate with one tablet once daily with a meal. In patients already on metformin, switch to this combination containing the same total daily dose of metformin, with empagliflozin 25 mg once daily. In patients on empagliflozin, switch to this combination containing metformin 1000 mg once daily, with the same total daily dose of empagliflozin. In patients treated with separate tablets of empagliflozin and metformin, switch to this combination containing the same total daily doses of each component.
• Swallow tablets whole with water; do not crush or chew. Assess renal function before initiating and periodically during treatment. This product is contraindicated in patients with eGFR < 45 mL/min/1.73 m².

Side Effects: Common side effects may include nausea, vomiting, diarrhea, headache, dizziness, fatigue, abdominal pain, and increased urination. Empagliflozin can increase the risk of urinary tract infections and genital mycotic infections. Metformin may cause gastrointestinal disturbances and, rarely, lactic acidosis. Hypoglycemia may occur when used in combination with insulin or sulfonylureas. Weight loss may also occur.

Precautions: Contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²), acute metabolic acidosis, diabetic ketoacidosis, or known hypersensitivity to empagliflozin or metformin. Not recommended in patients with eGFR between 30-44 mL/min/1.73 m². Avoid use in patients with active liver disease or excessive alcohol intake. Assess renal function before initiation and regularly thereafter. Monitor for signs and symptoms of lactic acidosis and diabetic ketoacidosis.

Storage: Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.