Synjardy 12.5 mg/1000 mg 60 tablets

Synjardy 12.5 mg 1000 mg 60 tablets

Composition:

Empagliflozin 12.5 mg.
Metformin hydrochloride 1000 mg.
Excipients:
Povidone.
Croscarmellose sodium.
Magnesium stearate.
Hypromellose.
Talc.
Titanium dioxide (E171).
Macrogol.

Product Description:

A combination drug containing the sodium‑glucose cotransporter 2 inhibitor empagliflozin and the biguanide metformin.
Empagliflozin lowers blood glucose levels by increasing its excretion in urine and reduces the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.
Metformin reduces glucose production in the liver and increases tissue sensitivity to insulin.
Combined use provides significant glycemic control and additional cardio‑renal protection.

Indications for use:

Type 2 diabetes mellitus in adults and adolescents ≥10 years as an adjunct to diet and exercise.
Reduction of risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease.
Reduction of risk of progression of chronic kidney disease, cardiovascular death, and hospitalization for heart failure.

Method of administration and dosage:

The initial dose usually corresponds to 5 mg/500 mg or 10 mg/1000 mg twice daily.
Maximum dose: 25 mg empagliflozin and 2000 mg metformin per day.
Tablets are taken orally with meals to reduce the risk of gastrointestinal reactions.
Dosage is adjusted individually depending on tolerability and renal function.

Contraindications:

Severe renal impairment (eGFR <30 ml/min/1.73 m²), end‑stage CKD or dialysis.
Metabolic acidosis, including diabetic ketoacidosis.
Hypersensitivity to empagliflozin, metformin, or excipients.

Precautions:

Risk of metformin‑associated lactic acidosis (especially in elderly patients, alcoholism, hypoxia, hepatic or renal impairment).
Risk of ketoacidosis even with moderate hyperglycemia.
Possibility of genitourinary infections and rare cases of necrotizing fasciitis of the perineum (Fournier’s gangrene).
Renal function should be monitored before and during therapy.

Adverse Reaction / Side effects:

Very common: gastrointestinal disorders (nausea, diarrhea).
Common: urinary tract infections, thirst, polyuria.
Sometimes: hypoglycemia (in combination with insulin or sulfonylurea).
Rare: lactic acidosis, ketoacidosis, allergic reactions.

Pregnancy and lactation:

Use is contraindicated due to lack of safety data.
Metformin and empagliflozin may pose a risk to the fetus and newborn.

Storage conditions:

Store at a temperature not exceeding 25 °C, in a dry place, protected from moisture and light, out of reach of children.

Packaging:

Cardboard box containing blisters with 60 film‑coated tablets.