POSIFORLID Eye ointment Ref.[51135] Active ingredients: Bibrocathol

Woolfat may cause local skin reactions (e.g. contact dermatitis).

Contact lenses should not be worn during use of Posiforlid 20 mg/g.

No interaction studies have been performed.

Note: In concomitant treatment with other eye drops/eye ointments an interval of at least 1 hour should be between the applications. Posiforlid 20 mg/g should definitely be applied at last.

Pregnancy

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 (see section 5.3). Posiforlid 20 mg/g, eye ointment should not be used during pregnancy unless clearly necessary.

Breastfeeding

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 Posiforlid 20 mg/g, 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 Posiforlid 20 mg/g 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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: ADR Reporting: Website: www.medicinesauthority.gov.mt/adrportal.

The active substance bibrocathol is incompatible with iron (III)-salts, oxidants, strong acids and strong alkalis.