Leaflet SOTRET 20mg soft capsules


Indicated for: acne

Route of administration: oral

Substance: isotretinoin (retinoid)

ATC: D10BA01 (Dermatologicals | Anti-acne preparations for systemic use | Retinoids for treatment of acne)

Precautions:
Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Photosensitivity
Photosensitivity

Avoid excessive exposure to sunlight or UV radiation.

Teratogenic / fetal risk
Teratogenic / fetal risk

This medicine may affect fetal development.

Isotretinoin is a medication used to treat severe acne that does not respond to other therapies. It is a derivative of vitamin A and works by reducing sebum production, inhibiting inflammation, and preventing the formation of comedones.

The medication is taken orally, usually once or twice daily, as directed by a doctor.

Side effects may include dryness of the skin and mucous membranes, increased sensitivity to sunlight, joint or muscle pain. In rare cases, severe adverse effects such as depression or liver dysfunction may occur.

Pregnant women must not use isotretinoin as it can cause severe birth defects. Effective contraception is required during treatment and for a period after its completion.

General data about SOTRET 20mg

  • Substance: isotretinoin
  • Date of last drug list: 01-06-2026
  • Commercial code: W65391002
  • Concentration: 20mg
  • Pharmaceutical form: soft capsules
  • Quantity: 30
  • Product type: generic
  • Price: 72.59 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: TERAPIA S.A - ROMANIA
  • Holder: TERAPIA S.A. - ROMANIA
  • Number: 10195/2017/02
  • Shelf life: 2 years

Concentrations available for isotretinoin

  • 10mg
  • 20mg

Combinations with other substances

Compensation lists for SOTRET 20mg Terapia

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

Price

Copayment

Patient

72.59 RON

36.29 RON

36.30 RON