Bibrocathol

There are no or limited amount of data from the use of bibrocathol in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Bibrocathol eye ointment should not be used during pregnancy unless clearly necessary.

It is unknown whether bibrocathol is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from bibrocathol eye ointment therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

No data on human fertility are available.

Due to its greasy consistency of bibrocathol eye ointment vision will be impaired after application. This affects the ability to drive and use machines. The patient should not drive and use machines until the vision is clear.

For the assessment of adverse reactions, the following frequencies of occurrence are defined: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1.000 to <1/100, Rare ≥1/10.000 to <1/1.000, Very rare <1/10.000, Not known: cannot be estimated from the available data.

Eye disorders

Rare: eye irritation including eye lid (e.g. eye itching, eye swelling, eye pain, ocular hyperaemia, burning sensation, tearing)

Immune system disorders

Rare: hypersensitivity, allergy (e. g. swelling of face, facial flushing)

Skin and subcutaneous tissue disorders

Rare: erythema, pruritus, rash