Leaflet MEDABON 200mg / 0.2mg tablets and vaginal tablets

Indicated for: medical termination of pregnancy

Route of administration: vaginal

Substance: mifepristone + misoprostol (hormone + vasodilator)

ATC: G03XB01 (Genito urinary system and sex hormones | Other sex hormones and modulators of the genital system | Progesterone receptor modulators)

Precautions:
Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hypotension / fall risk
Hypotension / fall risk

May lower blood pressure and increase the risk of falls.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Teratogenic / fetal risk
Teratogenic / fetal risk

This medicine may affect fetal development.

The combination of Mifepristone + misoprostol is used for terminating early pregnancies, typically up to 10 weeks of gestation. Mifepristone blocks the effects of progesterone, while Misoprostol stimulates uterine contractions, completing the medical abortion process.

The medications are administered orally or vaginally, according to a specific regimen, under medical supervision. This combination is highly effective in terminating pregnancies.

Side effects may include nausea, vomiting, abdominal cramps, diarrhea, and vaginal bleeding. In rare cases, severe complications such as infections or hemorrhage may occur. Close monitoring is essential.

Consult your doctor to discuss the benefits and risks of treatment with this combination. Use must occur exclusively under medical supervision.

General data about MEDABON 200mg / 0.2mg

  • Substance: mifepristone + misoprostol
  • Date of latest medicines list: 01-06-2026
  • Product code: W59313001
  • Concentration: 200mg / 0.2mg
  • Pharmaceutical form: tablets and vaginal tablets
  • Quantity: 1
  • Product type: Original
  • Price: 301.83 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V. - OLANDA
  • Holder: SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V. - OLANDA
  • Number: 10424/2017/01
  • Shelf life: 21 months

Pharmaceutical forms available for mifepristone + misoprostol

Concentrations available for mifepristone + misoprostol

  • 200mg/0.2mg
  • 600mg/400mcg