Leaflet ROACCUTANE 10mg soft capsules

Product code:
W71370001
Quantity:
30
Indicated for:
acne
Route of administration:
oral
Substance:
isotretinoin (retinoid)
ATC
D10BA01 — Dermatologicals | Anti-acne preparations | Anti-acne preparations for systemic use | Retinoids for treatment of acne

Precautions:

Contraception required

Effective contraception is required during treatment.

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Photosensitivity

Avoid excessive exposure to sunlight or UV radiation.

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.
ROACCUTANE 10mg soft capsules CHEPLAPHARM, isotretinoin

General data about ROACCUTANE 10mg

Substance:
isotretinoin
Date of latest medicines list:
01-06-2026
Product code:
W71370001
Concentration:
10mg
Pharmaceutical form:
soft capsules
Quantity:
30
Product type:
Original
Price:
62.39 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
ROCHE PHARMA AG - GERMANIA
Holder:
CHEPLAPHARM REGISTRATION GMBH - GERMANIA
Number:
7661/2015/01
Shelf life:
3 years

Concentrations available for isotretinoin

  • 10mg
  • 20mg

Combinations with other substances

Compensation lists for ROACCUTANE 10mg Cheplapharm

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

Price
62.39 RON
Copayment
19.70 RON
Patient
42.69 RON