Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

For Competact no preclinical or clinical data on exposed pregnancies or lactation are available.


Competact 15mg/850mg MF 05/2019 Notification
Women of childbearing potential / Contraception in males and females
Competact is not recommended in women of childbearing potential not using contraception. If a patient wishes to become pregnant, treatment with Competact should be discontinued.

Pregnancy

Risk related to pioglitazone
There are no adequate human data from the use of pioglitazone in pregnant women. Animal studies have not shown teratogenic effects but have shown foetotoxicity related to the pharmacologic action (see section 5.3).
Risk related to metformin
Animal studies have not revealed teratogenic effects. Small clinical trials have not revealed metformin to have malformative effects.
Competact should not be used during pregnancy. If a pregnancy occurs, treatment with Competact should be discontinued.

Breast-feeding

Both pioglitazone and metformin have been shown to be present in the milk of lactating rats. It is not known whether breast-feeding will lead to exposure of the infant to the medicinal product.
Competact must therefore not be used in women who are breast-feeding (see section 4.3).

Fertility

In animal fertility studies with pioglitazone, there was no effect on copulation, impregnation or fertility index.
Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.