Ferriprox 100 mg/ml oral solution

Pregnancy and breast-feeding

Ferriprox may cause harm to unborn babies when used by pregnant women. Ferriprox must not be used during pregnancy unless clearly necessary. If you are pregnant or you become pregnant during treatment with Ferriprox, get medical advice immediately.

Both female and male patients are recommended to take special precautions in their sexual activity if there is any possibility for pregnancy to occur: Women of childbearing potential are recommended to use effective contraception during treatment with Ferriprox and for 6 months after the last dose. Men are recommended to use effective contraception during treatment and for 3 months after the last dose. This should be discussed with your doctor.

Do not use Ferriprox if you are breast-feeding. Please refer to the patient card attached to the carton.

4.6      Fertility, pregnancy and lactation

Women of childbearing potential/contraception in men and women

Due to the genotoxic potential of deferiprone (see section 5.3), women of childbearing potential are recommended to use effective contraceptive measures and avoid becoming pregnant while being treated with Ferriprox and for 6 months following the completion of treatment.

Men are recommended to use effective contraceptive measures and to not father a child while receiving Ferriprox and for 3 months following completion of treatment.

• • Text of the patient card moved from the leaflet to the outer box