Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.

Pregnancy

Epiduo Forte 0.3%/2.5% gel is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy.

There are no or limited amount of data from the use of adapalene topically in pregnant women.

Animal studies by the oral route have shown reproductive toxicity at high systemic exposure (see section 5.3).
Clinical experience with locally applied adapalene and benzoyl peroxide in pregnancy is limited.
If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.

Breast-feeding
No study on animal or human milk transfer was conducted after cutaneous application of Epiduo Forte 0.3%/2.5% gel. Available pharmacokinetic data in rats have shown excretion of adapalene in milk after oral or intravenous administration of adapalene.
A risk to the suckling child cannot be excluded.


A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Epiduo Forte 0.3%/2.5% gel therapy weighting the benefit of breast-feeding for the child and the benefit of therapy for the woman.
To avoid contact exposure of the infant, application of Epiduo Forte 0.3%/2.5% gel to the chest should be avoided when used during breast-feeding.
Fertility
No human fertility studies were conducted with Epiduo Forte 0.3%/2.5% gel.
However, no effects of adapalene or benzoyl peroxide on fertility were found in rats in reproductive studies (see section 5.3).