Emjard M 500

Presentation:Each film-coated tablet contains 5 mg of empagliflozin and 500 mg of metformin hydrochloride.

Indications:Emjard M is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metforminis appropriate.This includes 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 controlledwith metformin and these medicinal products.  
• Already being treated with the combination of empagliflozin and metformin as separate tablets. Empagliflozin, a component of Emjard M 500, is also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovasculardisease.  

Dosage and Administration: The dosage should be individualized based on effectiveness and tolerability, not exceeding the maximum recommended daily dose of metformin hydrochloride (2000 mg) and empagliflozin (25 mg). Emjard M 500 is usually taken twice daily with meals to reduce gastrointestinal side effects associated with metformin.  

• For patients on metformin: Switch to Emjard M 500 containing 5 mg empagliflozin with a similar total daily dose of metformin.
• For patients on empagliflozin:Switch to Emjard M 500 containing 500 mg metformin with a similar total daily dose of empagliflozin.  
• For patients on separate empagliflozin and metformin: Switch to Emjard M 500 containing the same total daily doses of each component. Renal function should be assessed before initiating Emjard M 500 and periodically thereafter. Emjard M 500 is contraindicated in patients with an eGFR below 45 mL/min/1.73 m²  

Side Effects:Common side effects may include urinary tract infection, female genital mycotic infections, nausea, vomiting, diarrhea, abdominal pain, and increased urination.Hypoglycemia may occur when Emjard M 500 is used in combination with insulin or insulin secretagogues.  

Precautions:Emjard M 500 is contraindicated in patients with severe renal impairment (eGFR < 45 mL/min/1.73 m²), acute or chronic metabolic acidosis including diabetic ketoacidosis, or a history of serious hypersensitivity reaction to empagliflozin, metformin hydrochloride, or any of the excipients.It is not recommended for use in patients with type 1 diabetes. Assess renal function before initiation and monitor periodically. Avoid use in patients with hepatic impairment. Temporary discontinuation may be needed for surgery or iodinated contrast imaging. Counsel patients about the potential risk of lactic acidosis and diabetic ketoacidosis.

Storage: Store below 30°C. 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.