Empalina 25/5

Presentation: Each film-coated tablet contains 25 mg of empagliflozin and 5 mg of linagliptin.

Indications:Empalina is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellituswhen treatment with both empagliflozin and linagliptin is appropriate.²This includes patients:

• Inadequately controlled on metformin and either empagliflozin or linagliptin.
• Already being treated with empagliflozin and linagliptin as separate tablets.

Dosage and Administration: The recommended dose is one tablet of Empalina 25/5 once daily, preferably in the morning, with or without food. The dosage should be individualized based on the patient's current regimen.

• For patients inadequately controlled on metformin and either empagliflozin or linagliptin, the recommended dose is Empalina 25/5 once daily.
• For patients already taking empagliflozin and linagliptin as separate tablets, Empalina 25/5 can be used, providing the same daily doses. Renal function should be assessed before initiating Empalina and periodically thereafter. Empalina is not recommended for use in patients with an eGFR below 45 mL/min/1.73 m².

Side Effects: Common side effects may include urinary tract infections, nasopharyngitis, and hypoglycemia (when used in combination with insulin or sulfonylureas). Other possible side effects include genital mycotic infections in women, increased urination, and thirst. Pancreatitis has been reported with linagliptin. Ketoacidosis has been reported with empagliflozin.

Precautions: Empalina is contraindicated in patients with severe renal impairment (eGFR < 45 mL/min/1.73 m²), end-stage renal disease, or dialysis; a history of hypersensitivity reaction to empagliflozin, linagliptin, or any of the excipients; and a history of serious hypersensitivity reaction to linagliptin (such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity).It is not recommended for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Assess renal function before initiationand monitor periodically. Caution should be exercised in patients with a history of pancreatitis.

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.