Updated on 25/08/2026
ISOCNE 20 mg
Isotretinoin
Soft capsules
Treatment of severe acne
Packaging:
20 Softgels
CONTRAINDICATIONS:
Isotretinoin must not be used by pregnant women or by women who may become pregnant during treatment. Although not all fetuses exposed to isotretinoin will necessarily develop birth defects, there is an extremely high risk that a child will be born with birth defects if pregnancy occurs while taking isotretinoin, regardless of the dose, even for short periods.
Any fetus exposed during pregnancy is potentially at risk. At present, there is no reliable way to determine, after exposure to isotretinoin, which fetuses have been affected and which have not.
Isotretinoin is contraindicated in women of childbearing potential unless the patient meets all of the following conditions:
• Has severe, disfiguring nodular acne that is resistant to standard treatments (see the INDICATIONS section for the definition).
• Must be able to adhere to the mandatory contraceptive measures required during isotretinoin treatment and understand the behaviors associated with an increased risk of pregnancy.
Must have tested negative on a urine or blood pregnancy test at the time the prescriber authorizes treatment with isotretinoin, and must have a second negative result on a urine or blood pregnancy test either on the second day of the next normal menstrual period or at least 11 days after the last unprotected sexual intercourse, whichever is later.
Major human fetal abnormalities associated with isotretinoin administration have been documented, including:
central nervous system abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, and cranial nerve deficits);
skull abnormalities; external ear abnormalities (including anotia, microtia, and small or absent external auditory canals); ocular abnormalities (including microphthalmia); and cardiovascular abnormalities. Facial dysmorphia; cleft palate; thymus abnormality; parathyroid hormone deficiency. Effective contraception must be used for at least one month before starting isotretinoin treatment, throughout the duration of treatment, and for one month after treatment ends, even in cases of a history of infertility, unless the infertility results from a hysterectomy. No contraceptive method is 100% effective. It is therefore essential that women of childbearing age use two effective methods of contraception simultaneously, unless total abstinence is the chosen method, even when one of the methods is hormonal contraception.
If pregnancy occurs during treatment, the prescriber and the patient should discuss whether or not to continue the pregnancy.
Isocne is contraindicated in patients with hypersensitivity to this medication or to any of its components. Isocne should not be administered to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsules.
Isocne is also contraindicated during pregnancy, in cases of hypervitaminosis A, hepatic or renal insufficiency, in patients with excessively high blood lipid levels, and when used in combination with adjunctive treatment with tetracyclines.
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In accordance with legal and regulatory obligations governing health and safety, you can report any adverse event (medicinal or cosmetic) or suspected quality defect related to the use of one of our products.
This information is crucial for the ongoing evaluation of our safety profile. Please submit your report: directly to our monitoring department via the contact form for medications; and/or via our telephone number +33 (0)3 86 20 21 64.