Bilaxten ODT Use In Pregnancy & Lactation

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.
Breastfeeding: The excretion of bilastine in milk has not been studied in humans. Available pharmacokinetic data in animals have shown excretion of bilastine in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). A decision on whether to continue/discontinue breast-feeding or to discontinue/abstain from Bilastine (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 in fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).