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Pregnancy: There are no or limited amount of data from the use of bilastine in pregnant women.
Animal studies do not indicate direct-or-indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). As a precautionary measure, it is preferable to avoid the use of Bilastine (BILAXTEN) during pregnancy.
Breast-feeding: It is unknown whether bilastine is excreted in human breast milk. The excretion of bilastine in milk has not been studied in animals. A decision on whether to discontinue/abstain from Bilaxten therapy must be made taking into account the benefit of breast-feeding for the child and the benefit of bilastine therapy for the mother.
Fertility: There are no or limited amount of clinical data. A study in rats did not indicate any negative effect on fertility (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
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