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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 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).
