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Pregnancy: Ambroxol hydrochloride crosses the placental barrier.
Nonclinical studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Extensive clinical experience after the 28th week of pregnancy has shown no evidence of harmful effects on the foetus.
Nonetheless, the usual precautions regarding the use of drugs during pregnancy should be observed. Especially during the first trimester, the use of Ambroxol hydrochloride (Mucosolvan) is not recommended.
Lactation: Ambroxol hydrochloride is excreted in breast milk.
Although unfavourable effects on breastfed infants would not be expected, Ambroxol hydrochloride (Mucosolvan) is not recommended for use in nursing mothers.
Fertility: Nonclinical studies do not indicate direct or indirect harmful effects with respect to fertility.
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