Yellox

Posology Use in adults, including the elderly The dose is one drop of Yellox in the affected eye(s) twice daily, beginning the next day after cataract surgery and continuing through the first 2 weeks of the postoperative period. The treatment should not exceed 2 weeks as safety data beyond this is not available.

Hepatic and renal impairment Yellox has not been studied in patients with hepatic disease or renal impairment. Paediatric population The safety and efficacy of bromfenac in paediatric patients has not been established. No data are available.

Method of administration For ocular use. If more than one topical ophtalmic medicinal product is being used, each one should be administered at least 5 minutes apart. To prevent contamination of the dropper-tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper-tip of the bottle 3

4% of patients experienced one or more adverse reactions. 3%). Corneal adverse reactions were only observed in the Japanese population. 8%) patients who prematurely discontinued treatment in a study due to an adverse reaction. 1%) patient each with abnormal sensation in eye, corneal oedema, or eye pruritus.

Tabulated list of adverse reactions 5 The following adverse reactions were classified according to the following convention: 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The table below describes adverse reactions by system organ class and frequency. 4). 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 listed in Appendix V. 6

All topical NSAIDs may slow or delay healing like topical corticosteroids. Concomitant use of NSAIDs and topical steroids may increase the potential for healing problems. Cross-sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.

3). Susceptible persons In susceptible patients, continued use of topical NSAIDs, including bromfenac may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening.

Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Consequently in at risk patients concomitant use of ophthalmic corticosteroids with NSAIDs may lead to a higher risk of corneal adverse events.

g. dry eye syndrome, rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaema) in conjunction with ocular surgery. Yellox should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time.

g. in the form of macular oedema, due to the cataract operation may occur. Ocular infection An acute ocular infection may be masked by the topical use of anti-inflammatory medicinal products. Use of contact lenses In general, contact lens wear is not recommended during the postoperative period following cataract surgery.

Therefore, patients should be advised not to wear contact lenses during treatment with Yellox. 05 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should remove contact lenses before using this medicinal product and put them back 15 minutes afterwards.

1, or to other non- steroidal anti-inflammatory medicinal products (NSAIDs). Yellox is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other medicinal products with prostaglandin synthetase inhibiting activity.