Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

P regnancy
There are limited amount of data from the use of clobazam in pregnant women. Nevertheless, a large amount of data collected from cohort studies has not demonstrated evidence of the occurrence of major malformations following exposure to benzodiazepines during the first trimester of pregnancy, although incidence of cleft lip and palate were observed in case-control studies.
Clobazam is not recommended during pregnancy and in women of childbearing potential not using contraception. Clobazam crosses the placenta. Animal studies have demonstrated reproductive toxicity (see section 5.3).
Women of childbearing potential should be informed of the risks and benefits of the use of clobazam during pregnancy.
Women of childbearing potential should be informed to contact her physician regarding discontinuation of the product if they are pregnant or intend to become pregnant. If clobazam treatment is to be continued, use clobazam at the lowest effective dose.
Cases of reduced fetal movement and fetal heart rate variability have been described after administration of benzodiazepines during the second and/or third trimester of pregnancy.
If clobazam is administered during the late phase of pregnancy or during childbirth effects on the neonate, such as respiratory depression (including respiratory distress and apnoea), sedation signs, hypothermia, hypotonia, and feeding difficulties in the newborn (so-called “floppy infant syndrome”) are to be expected.
Moreover, infants born to mothers who have taken benzodiazepines over longer periods during the later stages of pregnancy may have developed physical dependence and may be at risk of developing a withdrawal syndrome in the postnatal period. Appropriate monitoring of the newborn in 7/8
the postnatal period is recommended.
B reast-feeding
Since benzodiazepines are found in the breast milk, benzodiazepines should not be given to breast- feeding mothers. F ertility
No clinical data on fertility are available. In a fertility study in male and female rats no effect on fertility was observed (see section 5.3).