Concor AMLO Use In Pregnancy & Lactation

Pregnancy: Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the foetus/newborn. In general, β-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, spontaneous abortion and early labour. Adverse effects (e.g. hypoglycaemia and bradycardia) may occur in the foetus and newborn infant. If treatment with β-adrenoceptor blockers is necessary, β1-selective adrenoceptor blockers are preferable.
The safety of amlodipine in human pregnancy has not been established.
Reproductive studies in rats have shown no toxicity except for delayed date of delivery and prolonged duration of labour at dosages 50 times greater than the maximum recommended dosage for humans.
Concor AMLO is not recommended during pregnancy unless clearly necessary. If treatment with Concor AMLO is considered necessary, the uteroplacental blood flow and the foetal growth should be closely monitored. In case of harmful effects on pregnancy or the foetus alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.
Breast-feeding: It is not known whether bisoprolol is excreted in human milk. Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 - 7%, with a maximum of 15%. The effect of amlodipine on infants is unknown. Therefore, administration of Concor AMLO is not recommended during breast-feeding.
Fertility: No human data on fertility are known for the combination product. Reversible biochemical changes in spermatozoa have been reported in some patients treated by calcium channel blockers, however clinical data are insufficient regarding the potential effect of amlodipine on fertility.
Bisoprolol had no influence on fertility or on general reproduction performance in animal studies, while amlodipine showed in a published investigation adverse effects on male fertility parameters (see Pharmacology: Toxicology: Preclinical safety data under Actions).