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Bromfenac

Interactions

Active ingredient Bromfenac interacts in the following cases:

Effects on ability to drive and use machines

Bromfenac has minor influence on the ability to drive and use machines. Transient blurring of vision may occur on instillation. If blurred vision occurs at instillation patients should be advised to refrain from driving or using machines until vision is clear.

Pregnancy

There are no adequate data from the use of bromfenac in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Since the systemic exposure in non-pregnant women is negligible after treatment with bromfenac, the risk during pregnancy could be considered low.

However, because of the known effects of prostaglandin biosynthesis-inhibiting medicinal products on the foetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac during third trimester pregnancy should be avoided. The use of bromfenac is in general not recommended during pregnancy unless the benefit outweighs the potential risk.

Pregnancy

There are no adequate data from the use of bromfenac in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Since the systemic exposure in non-pregnant women is negligible after treatment with bromfenac, the risk during pregnancy could be considered low.

However, because of the known effects of prostaglandin biosynthesis-inhibiting medicinal products on the foetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac during third trimester pregnancy should be avoided. The use of bromfenac is in general not recommended during pregnancy unless the benefit outweighs the potential risk.

Nursing Mothers

It is unknown whether bromfenac or its metabolites are excreted in human milk. Animal studies have shown excretion of bromfenac in the milk of rats following very high oral doses. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to bromfenac is negligible. Bromfenac can be used during breast-feeding.

Carcinogenesis, Mutagenesis and Fertility

Fertility

No effects of bromfenac on the fertility were observed in animal studies. In addition the systemic exposure to bromfenac is negligible; for this reason no pregnancy testing or contraceptive measures are required.

Effects on Ability to Drive and Use Machines

Bromfenac has minor influence on the ability to drive and use machines. Transient blurring of vision may occur on instillation. If blurred vision occurs at instillation patients should be advised to refrain from driving or using machines until vision is clear.