Tapcom-S Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data from the use of Tapcom-S in pregnant women.
Women of childbearing potential have to use effective contraception during Tapcom-S treatment.
Tapcom-S should not be used during pregnancy unless clearly necessary (in case no other treatment options are available).
Tafluprost: There are no adequate data for the use of tafluprost in pregnant women. Tafluprost can have harmful pharmacologic effects on pregnancy and/or the foetus/newborn child. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
Timolol: There are no adequate data for the use of timolol in pregnant women. Timolol should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see Dosage & Administration.
Epidemiological studies have not revealed malformative effects but show a risk for intra uterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If Tapcom-S is administered until delivery, the neonate should be carefully monitored during the first days of life.
Lactation: Beta-blockers are excreted in breast milk. However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. To reduce the systemic absorption, see Dosage & Administration.
It is unknown whether tafluprost and/or its metabolites are excreted in human milk. Available toxicological data in animals have shown excretion of tafluprost and/or its metabolites in milk (for details, see Pharmacology: Toxicology: Preclinical safety data under Actions). However, at therapeutic doses of tafluprost in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms in the infant.
As a precautionary measure lactation is not recommended if treatment with Tapcom-S is required.
Fertility: There are no data on the effects of Tapcom-S on human fertility.