Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, Pregnancy and Lactation
Pregnancy

Pseudoephedrine
There is a possible association between the development of fetal abnormalities and first trimester exposure to pseudoephedrine. Therefore the use of pseudoephedrine during pregnancy should be avoided.

Ibuprofen
Whilst no teratogenic effects have been demonstrated in animal experiments, the use of ibuprofen should, if possible, be avoided during the first 6 months of pregnancy. During the 3rd trimester, ibuprofen is contraindicated, as there is a risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child.

Rarely, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) after 20 weeks gestation in pregnancy may cause fetal renal dysfunction leading to oligohydramnios.

These effects are seen after days to weeks of treatment. Although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation.

The use of NSAIDs after week 20 of gestation should be restricted. If the benefit of NSAID treatment is considered greater than the risk, limit use to the lowest effective dose and shortest duration possible.

Consider ultrasound monitoring of amniotic fluid if NSAID treatment of this medicine at the full treatment dosage extends beyond five days. Discontinue the NSAID if oligohydramnios occurs.


Breast-feeding
Ibuprofen
In limited studies, ibuprofen appears in the breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.

Pseudoephedrine
Pseudoephedrine is excreted in breast milk in small quantities, but the effect of this on breast-fed infants is not known.
It is estimated that 0.4% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in breast milk over 24 hours.

In summary, the use of this product is contraindicated during pregnancy and breast-feeding (see section 4.3).

Fertility
There is limited evidence that drugs which inhibit cyclo-oxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.