Leaflet DIBAGLEP 100mg / 10mg film-coated tablets


Indicated for: type 2 diabetes mellitus

Substance: sitagliptin + dapagliflozin (DPP-4 inhibitor + SGLT2 inhibitor)

ATC: A10BD29 (Alimentary tract and metabolism | Blood glucose lowering drugs, excl. insulins | Combinations of oral blood glucose lowering drugs)

Sitagliptin with dapagliflozin is a combination used in adults with type 2 diabetes as an add-on to diet and exercise when blood glucose is not adequately controlled with other treatment, or when the two medicines are already being taken separately. Sitagliptin increases the effect of incretin hormones, while dapagliflozin removes extra glucose through urine.

It is taken by mouth, usually as one tablet once daily, exactly as prescribed. It is not intended for type 1 diabetes and does not replace healthy eating, physical activity or glucose monitoring. Your doctor will decide whether it should be used with metformin, insulin or other diabetes medicines and may adjust doses to reduce hypoglycaemia risk.

Side effects may include urinary tract infections, genital infections, passing urine more often, thirst, nausea, headache or dizziness. Low blood sugar is more likely when insulin or a sulfonylurea is also used. Rare but important risks include pancreatitis, severe allergy, dehydration, kidney problems and diabetic ketoacidosis. Seek urgent help for severe abdominal pain, rapid breathing, vomiting or confusion.

During treatment, blood glucose, HbA1c, kidney function and blood pressure should be checked. Drink enough fluids, especially during fever, vomiting, diarrhoea or hot weather. Tell your doctor before surgery, prolonged fasting or very low-carbohydrate diets, because temporary interruption may be needed. Always mention all medicines and supplements you take.

General data about DIBAGLEP 100mg / 10mg

  • Substance: sitagliptin + dapagliflozin
  • Commercial code: W71865001
  • Concentration: 100mg / 10mg
  • Pharmaceutical form: film-coated tablets
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A. - GRECIA
  • Holder: VIATRIS LIMITED - IRLANDA
  • Number: 16557/2026/01
  • Shelf life: 18 months