Leaflet ISOTREXIN gel 0.5mg / 20mg / g

Product code:
W56787001
Quantity:
1
Indicated for:
acne vulgaris
Route of administration:
cutaneous
Substance:
isotretinoin + erythromycin (retinoid + macrolide antibiotic)
ATC
D10AD54 — Dermatologicals | Anti-acne preparations | Anti-acne preparations for topical use | Retinoids for topical use in acne

Precautions:

Anaphylaxis

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

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.

The combination of isotretinoin and erythromycin is used to treat moderate to severe acne. Isotretinoin reduces sebum production and inflammation, while erythromycin is an antibiotic that targets bacteria associated with acne.

The medication is available as a gel or cream and is applied topically to affected areas, usually once or twice daily, as directed by a doctor.

Side effects may include local irritation, dryness, or redness of the skin. In rare cases, severe allergic reactions may occur.

Patients should avoid prolonged sun exposure and use sunscreen. Pregnant or breastfeeding women should consult a specialist before use.

General data about ISOTREXIN GEL 0.5mg / 20mg / g

Substance:
isotretinoin + erythromycin
Date of latest medicines list:
01-07-2021
Product code:
W56787001
Concentration:
0.5mg / 20mg / g
Pharmaceutical form:
gel
Quantity:
1
Product type:
Generic medicine
Prescription status:
P-6L — Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

Manufacturer:
STIEFEL LABORATORIES (IRELAND) LTD. - IRLANDA
Holder:
GLAXOSMITHKLINE (GSK) S.R.L. - ROMANIA
Number:
5856/2013/01
Shelf life:
18 months

Concentrations available for isotretinoin + erythromycin

  • 0.05%/0.2%
  • 0.5mg/20mg/g