Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

There is insufficient experience in humans regarding the effects of Sativex on reproduction. Although no effect has been seen on fertility, independent research in animals found that cannabinoids affected spermatogenesis (section 5.3).
Therefore men and women of child bearing potential should take reliable contraceptive precautions for the duration of therapy and for three months after discontinuation of therapy.

Patients on hormonal contraceptives should be advised to use an additional alternative, nonhormonal/ reliable barrier method of birth control during Sativex therapy.

Pregnancy
Sativex should not be used during pregnancy unless the potential risks to the fetus and/or embryo are considered to be outweighed by the benefit of treatment.

Lactation
Available pharmacodynamics / toxicological data in animals have shown excretion of Sativex / metabolites in milk (for details see section 5.3). A risk to the breastfed child cannot be excluded.
Sativex is contraindicated during breast-feeding (see section 4.3).

Fertility
In fertility studies in rodents, there was no effect of treatment with Sativex in males or females. There was no effect on fertility of the offspring from mothers treated with Sativex.