Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development.
Data from epidemiological studies suggest an increased risk of miscarriage and or cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1% up to approximately 1.5%.

The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has shown to result in increased pre-and post-implantation loss and embryo-foetal lethality.

In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during organogenetic period.

CAT API 02JUN24                                                                       UK SmPC Feb2023 From the 20th week of pregnancy onward, Cataflam use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arterious constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, Cataflam should not be given unless clearly necessary. If Cataflam is used by a woman attempting to conceive, or during the first or second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to diclofenac for several days from gestational week 20 onward. Cataflam should be discontinued if oligohydramnios or ductus arteriosus constriction is found.


During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: -cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension);
-renal dysfunction (see above);,

The mother and the neonate, at the end of the pregnancy, to:
-      possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; -      inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, Cataflam is contraindicated during the third trimester of pregnancy.

Lactation
Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be administered during breast feeding in order to avoid undesirable effects in the infant (see section 5.2 Pharmacokinetic properties).

Female fertility
As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who may have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.

See section 4.4 Special warnings and precautions for use, regarding female fertility.