Evania M 12.5/500

Indicated for the treatment of adults with Type 2 Dabetes Mellitus as an adjunct to diet and exercise.

The dosage should be adjusted according to effectiveness and tolerability. Take this combination twice a day, with meals. To reduce the gastrointestinal side effects associated with Metformin Hydrochloride, dose escalation should be gradual. The maximum recommended daily dose of Metformin Hydrochloride is 2000 mg, while Empagliflozin is 25 mg.

The standard starting dose for empagliflozin + metformin hydrochloride is 5 mg of empagliflozin and 500 mg of metformin hydrochloride once daily. The dose can be gradually increased to a maximum of 25 mg of empagliflozin and 2,000 mg of metformin hydrochloride per day.

The safety and efficacy of this medication in children under the age of 18 has not been established.

Before starting this combination with a renally impaired patient, assess their renal function.In patients with an eGFR below 45 mL/min/1.73 m2 is contraindicated.

•Type 1 diabetes •Diabetic ketoacidosis (DKA) •Severe kidney disease (eGFR < 30 mL/min/1.73 m2) •Severe liver disease •Heart failure •Active bladder infection •Recent surgery or major trauma •Hypersensitivity to empagliflozin or metformin hydrochloride History of lactic acidosis. • History of urinary tract infections or genital yeast infections •Risk of dehydration •Elderly patients

By blocking SGLT2, empagliflozin prevents glucose from being reabsorbed and allows it to be excreted in the urine and decreasing the production of glucose in the liver and increasing the sensitivity of cells to insulin .It work synergistically to lower blood sugar levels more effectively.

Empagliflozin + metformin hydrochloride should not be used by individuals with - • Type 1 diabetes. • Diabetic ketoacidosis • Severe kidney disease • Severe liver diseases • Heart failure. • Active bladder infection. • Recent surgery or significant trauma

Serious side effects: • Diabetic ketoacidosis (DKA) • Lactic acidosis • Hypoglycemia (low blood sugar) • Dehydration • Urinary tract infections • Female genital mycotic infections • urticaria, dysuria • Vaginal moniliasisia Common side effects : • Increased urination • Thirst • Dry mouth • Nausea • Vomiting • Diarrhea • Abdominal pain • Headache • Dizziness • Fatigue • Weight loss

Pregnancy: It is s not recommended for use during pregnancy due to potential risk to a fetus especially during the second and third trimesters. Lactation: Empagliflozin is excreted in breast milk and may be harmful to the nursing infant. Metformin hydrochloride is also excreted in breast milk, but it is unclear whether it can harm a nursing infant.

It may interact with other medications, including: •Insulin: Empagliflozin + metformin hydrochloride can increase the risk of hypoglycemia (low blood sugar) when used with insulin. •Sulfonylureas: Empagliflozin + metformin hydrochloride can also increase the risk of hypoglycemia when used with sulfonylureas, another type of medication used to treat type 2 diabetes. •Meglitinides: Empagliflozin + metformin hydrochloride can also increase the risk of hypoglycemia when used with meglitinides, another type of medication used to treat type 2 diabetes. •Thiazolidinediones: Empagliflozin + metformin hydrochloride may increase the risk of heart failure when used with thiazolidinediones, another type of medication used to treat type 2 diabetes. •Alpha-glucosidase inhibitors: Empagliflozin + metformin hydrochloride may decrease the effectiveness of alpha-glucosidase inhibitors, another type of medication used to treat type 2 diabetes. •Beta-blockers: Empagliflozin + metformin hydrochloride may mask the symptoms of hypoglycemia, such as increased heart rate and sweating, when used with beta-blockers. •ACE inhibitors: Empagliflozin + metformin hydrochloride may increase the risk of hypotension (low blood pressure) when used with ACE inhibitors. •ARBs: Empagliflozin + metformin hydrochloride may increase the risk of hypotension when used with ARBs. •Diuretics: Empagliflozin + metformin hydrochloride may increase the risk of dehydration when used with diuretics. •Steroids: Empagliflozin + metformin hydrochloride may increase the risk of hyperglycemia (high blood sugar) when used with steroids. •Thyroid hormones: Empagliflozin + metformin hydrochloride may increase the risk of hypoglycemia when used with thyroid hormones.

Store below 30°C temperature, protected from light & moisture. Keep out of the reach of children.