Pantonil Use In Pregnancy & Lactation

General advice: Pregnancy Category: B.
Women with childbearing potential/Contraception: Specific testing with an oral contraceptive containing levonorgestrel and ethinyl estradiol did not show any clinically significant interaction (see Interactions).
Pregnancy: Data from a limited number of pregnancy exposure cases (between 300-1000 pregnancy outcomes) do not indicate that pantoprazole has adverse effects (inducing malformations or having feto/neonatal toxicity) on pregnancy or on the health of the fetus/newborn child.
No important epidemiological data have been obtained. Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. Pantoprazole should not be used during pregnancy unless clearly necessary.
As a precautionary measure, it is preferable to avoid the use of PANTONIL during pregnancy.
Breast-feeding: Animal studies have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. A risk to the newborns/infants cannot be excluded. Therefore, a decision on whether to discontinue breast-feeding or to discontinue/abstain from PANTONIL therapy should take into account the benefit of breast-feeding for the child, and the benefit of PANTONIL therapy for the woman.
Fertility: There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).
In the reproductive studies in animals, mild levels of fetotoxicity were observed at doses above 5 mg/kg. There is no evidence of fertility loss or teratogenicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).