Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
There are no adequate and well-controlled clinical studies in pregnant or breast-feeding women for the combination of paracetamol and pseudoephedrine.
This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus or breastfeeding infant.
Pregnancy
The safety of pseudoephedrine in pregnancy has not been established.
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
There is no adequate data from the use of chlorphenamine maleate in pregnant women. The potential risk for humans is unknown. Use during the third trimester may result in reactions in the newborn or premature neonates. Not to be used during pregnancy unless considered essentially by a physician.
Breastfeeding
Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known. It has been estimated that approximately 0.4 to 0.7% of a single 60 mg dose of pseudoephedrine ingested by a nursing mother will be excreted in the breast milk over 24 hours. Data from a study of lactating mothers taking 60 mg pseudoephedrine every 6 hours suggests that from 2.2 to 6.7% of the maximum daily dose (240 mg) may be available to the infant from a breastfeeding mother.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding. A pharmacokinetic study of paracetamol in 12 nursing mothers revealed that less than 1% of a 650 mg oral dose of paracetamol appeared in the breast milk. Similar findings have been reported in other studies, therefore maternal ingestion of therapeutic doses of paracetamol does not appear to present a risk to the infant.
Chlorphenamine maleate and other antihistamine may inhibit lactation and may be secreted in breast milk.
Not to be used during lactation unless considered essential by a physician.

Fertility
No studies have been conducted in animals to determine whether pseudoephedrine has the potential to impair fertility.
There is no information of the effect of this medicine on fertility.