Pregnancy & Lactation : הריון/הנקה

4.6 Pregnancy and lactation
Pregnancy
No reproductive toxicity studies have been conducted with Voltaren Ophtha Eye Drops.
Preclinical data: Systemic diclofenac has been shown to cross the placental barrier in mice and rats, but had no influence on the fertility of parent animals in rats. There was no evidence that diclofenac had a teratogenic potential in routine mice, rat or rabbit embryo-foetal development studies. In rats, maternally toxic doses were associated with dystocia, prolonged gestation, decreased foetal survival, and intrauterine growth retardation. The slight effects of diclofenac on fertility and delivery as well as constriction of the ductus arteriosus in utero are pharmacological consequences of this class of prostaglandin synthesis inhibitors.
The prenatal, perinatal and postnatal development of the offspring were not affected.
Animal studies have so far shown no risk to the foetus during the first and second trimesters of pregnancy, but no controlled studies in pregnant women are available.


3    VOL API MAY13 CL V1 COR MAT CL                                               Alcon MAT Voltaren Ophtha Eye Drops should not be used during the third trimester of pregnancy, due to possible risk of premature closure of the ductus arteriosus and possible inhibition of contractions (uterine inertia).
Lactation
Following oral administration of 50 mg coated tablets (content of 10 bottles of 5 ml each of Voltaren Ophtha Eye Drops) only traces of the active substance were detected in breast milk and in quantities so small that no undesirable effects on the infant are to be expected.
Use of ocular diclofenac is not recommended during breast-feeding unless the expected benefits outweigh the possible risks.