<p>Isotretinoin is contraindicated in women who are pregnant or breastfeeding. Isotretinoin is contraindicated in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met. Isotretinoin is also contraindicated in patients with hypersensitivity to Isotretinoin or to any of the excipients. Isotretinoin is also contraindicated in patients with hepatic insufficiency, with excessively elevated blood lipid values, with hypervitaminosis A, receiving concomitant treatment with tetracyclines.<br />
<br />
This medicinal product is contraindicated in women of childbearing potential unless all of the following conditions of the Pregnancy Prevention Programme are met: She has severe acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic anti-bacterials and topical therapy. She understands the teratogenic risk. She understands the need for rigorous follow-up, on a monthly basis. She understands and accepts the need for effective contraception, without interruption, 1 month before starting treatment, throughout the duration of treatment and 1 month after the end of treatment. At least one and preferably two complementary forms of contraception including a barrier method should be used. Even if she has amenorrhea she must follow all of the advice on effective contraception. She should be capable of complying with effective contraceptive measures. She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy. She understands the need and accepts to undergo pregnancy testing before, during and 5 weeks after the end of treatment. She has acknowledged that she has understood the hazards and necessary precautions associated with the use of Isotretinoin. These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy. The prescriber must ensure that the patient complies with the conditions for pregnancy prevention as listed above, including confirmation that she has an adequate level of understanding. The patient has acknowledged the aforementioned conditions. The patient has used at least one and preferably two methods of effective contraception including a barrier method for at least 1 month prior to starting treatment and is continuing to use effective contraception throughout the treatment period and for at least 1 month after cessation of treatment. Negative pregnancy test results have been obtained before, during and 5 weeks after the end of treatment. The dates and results of pregnancy tests should be documented.</p>