Faglozino 25 mg 30 tablets
Debeiky pharma
Debeiky pharma
Composition
Empagliflozin 25 mg.
Lactose monohydrate.
Microcrystalline cellulose.
Hydroxypropylcellulose.
Croscarmellose sodium.
Colloidal anhydrous silica.
Magnesium stearate.
Opadry (film coating).
Product Description
The drug belongs to the class of sodium‑glucose cotransporter 2 (SGLT2) inhibitors, reduces blood glucose levels by increasing its excretion in urine.
Indications for use
Type 2 diabetes mellitus (as monotherapy or in combination with other hypoglycemic agents).
Reduction of risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.
Treatment of chronic heart failure (NYHA II–IV) regardless of ejection fraction.
Treatment of chronic kidney disease to reduce risk of disease progression and cardiovascular death.
Method of administration and dosage
The recommended dose is 10 mg once daily.
If enhanced glycemic control is required in patients with preserved renal function (eGFR ≥60 ml/min/1.73 m²), the dose may be increased to 25 mg once daily.
Maximum daily dose — 25 mg.
Tablets are taken orally with water, regardless of food intake.
Contraindications
Hypersensitivity to the components of the drug.
Severe renal impairment (eGFR <30 ml/min/1.73 m²).
Diabetic ketoacidosis.
Age under 18 years.
Precautions
Monitoring of renal function before and during treatment.
Caution when combined with insulin or sulfonylurea derivatives (risk of hypoglycemia).
Risk of dehydration and hypotension in elderly patients.
Adverse reaction / Side effects
Common: urinary tract infections, polyuria.
Sometimes: thirst, itching, skin rashes.
Rare: ketoacidosis, decreased blood pressure, allergic reactions.
Pregnancy and lactation
Use is contraindicated.
Safety data are insufficient, possible risk to fetus and newborn.
Storage conditions
Store at a temperature not exceeding 25 °C, in a dry place, out of reach of children.
Packaging
Cardboard box, 30 tablets.