Description
Diacurimap 10 mg 30 Film-coated tablets.
Composition:
Diacurimap 10 mg film-coated tablets: Each tablet contains 25 mg empagliflozin.
Indications:
-Type 2 diabetes mellitus: Diacurimap is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
-as monotherapy when metformin is considered inappropriate due to intolerance.
-in addition to other medicinal products for the treatment of diabetes.
-Heart failure: Diacurimap is indicated in adults for the treatment of symptomatic chronic heart failure.
Dosage and Method of Administration:
Posology:
-Type 2 diabetes mellitus: The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other medicinal products for the treatment of diabetes. In patients tolerating empagliflozin 10 mg once daily who have an eGFR ≥ 60 ml/min/1.73 m? and need tighter glycemic control, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg.
-Heart failure: The recommended dose is 10 mg empagliflozin once daily.
Method of administration: The tablets can be taken with or without food, swallowed whole with water.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use:
-Ketoacidosis: In patients where ketoacidosis is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately.
-Treatment should be interrupted in patients who are hospitalized for major surgical procedures or acute serous medical illnesses
-For the Indication of type 2 diabetes mellitus, in patients with an eGFR below 60 ml/min/1.73m2 or CrCl < 60 ml/min/ the daily dose of empagliflozin is limited to 10 mg.
-Empagliflozin is not recommended when eGFR is below 30 ml/min/1.73m2 or CrCl below 30 ml/min.
-For the indication of heart failure, Diacurimap is not recommended in patients with eGFR ml/min/1.73 m2.
-Monitoring of renal function: Assessment of renal function is recommended.
-Elderty: The effect of empagliflozin on urinary glucose excretion is associated with osmotic diuresis, which could affect the hydration status.
-Temporary interruption of empagliflozin should be considered in patients with complicated urinary tract.
Pregnancy and lactation:
Pregnancy: As a precautionary measure, it is preferable to avoid the use of Diacurimap during pregnancy.
Breastfeeding: Diacurimap should not be used during breast-feeding.
Side Effects:
-Metabolism and nutrition disorders: Hypoglycaemia (when used with sulphonylurea or insulin), Thirst.
-Vascular disorders: Volume depletion
-Infections and infestations: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection, Urinary tract infection including pyelonephritis and urosepsis).
-Gastrointestinal disorders: Constipation.
-Skin and subcutaneous tissue disorders: Pruritus (generalised), Rash.
-Renal and urinary disorders: Increased urination.
-Investigations: Serum lipids increased.
Storage Method:
Store at a temperature not exceeding 30° in a dry place.
Package:
A Carton box contains 3 blisters each of 10 film coated tablets + an inner leaflet.
