Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, Pregnancy and lactation

Women of child-bearing potential:
There is no data to support any special recommendations in women of child- bearing potential.

Fertility
Treatment of male rats with a toxic oral dose of ketotifen (50 mg/kg/day) for 10 weeks prior to mating resulted in decreased fertility, but was not impaired at doses relevant for human use. The fertility of female rats as well as prenatal development, pregnancy and weaning of the offspring were not adversely affected by ketotifen treatment at oral dose levels of up to 50 mg/kg per day.
There is no data available on the effect of Profiten on fertility in humans.

Pregnancy
There are no or limited amount of data from the use of ketotifen in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Profiten should not be used during pregnancy unless the clinical condition of the woman requires treatment with ketotifen.

Breast-feeding
Available data in rats shown excretion of ketotifen in milk, while there is no human data available. It is assumed that this drug is also excreted in human breast milk, a n d therefore mothers receiving Profiten should not breast-feed (see section 4.3).