Leaflet DUPHASTON 10mg film-coated tablets

Indicated for: disorders associated with progesterone deficiency

Route of administration: oral

Substance: dydrogesterone (progestogen)

ATC: G03DB01 (Genito urinary system and sex hormones | Progestogens | Pregnadien derivatives)

Precautions:
Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Dydrogesterone is a synthetic progestogen used to treat various gynecological conditions associated with progesterone deficiency. It is similar to natural progesterone but has a modified chemical structure, which provides better tolerability and fewer side effects. It is commonly used for menstrual disorders, infertility, endometriosis, and hormone replacement therapy (HRT) in postmenopausal women.

Dydrogesterone works by compensating for progesterone deficiency, a hormone essential for regulating the menstrual cycle and maintaining pregnancy. It is used to treat conditions such as dysmenorrhea (painful periods), premenstrual syndrome, secondary amenorrhea (absence of menstruation), and dysfunctional uterine bleeding. It is also indicated for luteal phase support in women undergoing fertility treatments.

Although dydrogesterone is well-tolerated, it may cause some side effects. The most common include headaches, nausea, breast tenderness, bloating, or mood changes. In rare cases, allergic reactions or intermenstrual bleeding may occur. It is important for patients to inform their doctor of any side effects or unusual symptoms.

Dydrogesterone should be used as directed by a doctor, and the dosage and duration of treatment must be strictly followed. It is contraindicated in women with severe liver disease, unexplained vaginal bleeding, or hypersensitivity to the active substance. Periodic monitoring is necessary during treatment, especially for long-term use or when combined with estrogens.

General data about DUPHASTON 10mg

  • Substance: dydrogesterone
  • Date of latest medicines list: 01-06-2026
  • Product code: W62383002
  • Concentration: 10mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 20
  • Product type: Original
  • Price: 30.80 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: ABBOTT BIOLOGICALS B.V. - OLANDA
  • Holder: MYLAN HEALTHCARE B.V. - OLANDA
  • Number: 2078/2009/01
  • Shelf life: 5 years

Compensation lists for DUPHASTON 10mg BGP Products

B - Sublist B with 50% discount from the reference price

Price

Copayment

Patient

30.80 RON

15.40 RON

15.40 RON