Updated on 25/08/2026
ISOCNE 10 mg
Isotretinoin
Soft capsule
Treatment of severe acne
Packaging:
30 Softgels
CONTRAINDICATIONS:
Isotretinoin must not be used in women who are pregnant or who may become pregnant during treatment. Although not all pregnancies exposed to isotretinoin have resulted in the birth of a child with birth defects, there is an extremely high risk of birth defects if pregnancy occurs while taking isotretinoin, regardless of the dose, even for a short period of time. Potentially, any fetus exposed during pregnancy may be affected. 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 comply with the mandatory contraceptive measures required during isotretinoin treatment and understand the behaviors associated with an increased risk of pregnancy.
• Must be able to comply with the mandatory contraceptive measures required during treatment with isotretinoin 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 also have a second negative result from 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 linked to the administration of isotretinoin have been documented: central nervous system (CNS) abnormalities (including cerebral abnormalities, cerebellar malformations, hydrocephalus, microcephaly, and cranial nerve deficits); skull abnormalities; external ear abnormalities (including anotia, microtia, small or absent external auditory canals); ocular abnormalities (including microphthalmia); cardiovascular abnormalities; facial dysmorphia; cleft palate; thymus abnormalities; 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 stopping treatment, even in cases of a history of infertility, unless the infertility results from a hysterectomy.
No method of contraception is completely foolproof. 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 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 concomitant treatment with tetracyclines.
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