Leaflet JANUVIA 50mg film-coated tablets


Indicated for: type 2 diabetes mellitus

Substance: sitagliptin (DPP-4 inhibitor)

ATC: A10BH01 (Alimentary tract and metabolism | Blood glucose lowering drugs, excl. insulins | Dipeptidyl peptidase 4 (DDP-4) inhibitors)

Sitagliptin is a medication used to treat type 2 diabetes. It belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors, which work by increasing the levels of incretin hormones. These hormones stimulate insulin secretion and reduce glucagon production, thereby lowering blood sugar levels, especially after meals.

Sitagliptin is taken orally, usually once daily, with or without food. It is used either as monotherapy or in combination with other antidiabetic medications, such as metformin or sulfonylureas, to improve glycemic control.

Common side effects include headaches, upper respiratory tract infections, nasal congestion, and abdominal pain. In rare cases, it may cause more serious reactions, such as pancreatitis, severe allergic reactions (angioedema, urticaria), or severe joint pain.

Sitagliptin is not indicated for the treatment of type 1 diabetes or diabetic ketoacidosis. It is important for patients to follow their doctor's recommendations, regularly monitor blood sugar levels, and report any adverse reactions or changes in health.

JANUVIA 50mg film-coated tablets MERCK SHARP DOHME, sitagliptin

General data about JANUVIA 50mg

  • Substance: sitagliptin
  • Date of last drug list: 01-05-2026
  • Commercial code: W64964002
  • Concentration: 50mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 28
  • Product type: original
  • Price: 79.66 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: MERCK SHARP & DOHME LTD. - MAREA BRITANIE
  • Holder: MERCK SHARP & DOHME B.V. - OLANDA
  • Number: 383/2007/08
  • Shelf life: 3 years

Pharmaceutical forms available for sitagliptin

Concentrations available for sitagliptin

  • 100mg
  • 25mg
  • 25mg/ml
  • 50mg
  • 50mg/1000mg
  • 50mg/850mg
PDF icon EMA leaflet
Published: 09/12/2009
Updated: 31/10/2025

Compensation lists for JANUVIA 50mg Merck Sharp & Dohme

NHP 5 (C2) - Diabetes

Price

Copayment

Patient

79.66 RON

56.28 RON

23.38 RON