INTRODUCTION
Nepeye is a sterile, topical, nonsteroidal anti-inflammatory prodrug (NSAID) for ophthalmic use.

INDICATIONS
Nepeye is indicated for the treatment of pain and inflammation associated with cataract surgery

DIRECTIONS
Shake well before use. One drop of Nepeye should be applied to the conjunctival sac of the affected eye(s) three times daily beginning 1 day prior to cataract surgery continued on the day of surgery and through the first 2 weeks of the postoperative period. Nepeye ophthalmic suspension may be administered in conjunction with other topical ophthalmic medications such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics and mydriatics.
If more than one topical ophthalmic medicinal product is being used the medicines must be administered at least 5 minutes apart. The dropper tip should not be allowed to touch any surface since this may contaminate the solution. Elderly: No overall differences in safety and effectiveness have been observed between elderly and younger patients. Pediatric use : Nepeye is not recommended for use in children below 10 years due to lack of data on safety and efficacy.

WARNINGS
FOR EXTERNAL USE ONLY. NOT FOR INJECTION. With some nonsteroidal anti-inflammatory drugs including nepafenac, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteriodal antiinflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.Hence it is recommended that nepafenac ophthalmic suspension should be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time .Topical nonsteroidal anti-inflammatory drugs (NSAIDs) including nepafenac, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.Use of topical NSAIDs may result in keratitis in some susceptible patients, continuous use of topical NSAIDs 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 including nepafenac and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation corneal epithelial defects, diabetes mellitus ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post surgery may increase patient risk for occurrence and severity of corneal adverse events. Nepafenac ophthalmic suspension should not be administered while wearing contact lenses.

SIDE EFFECTS
In controlled clinical studies, the most frequently reported ocular adverse events following cataract
surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky
sensation. These events occurred in approximately 5 to 10% patients. Other ocular adverse events occuring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment. Some of these events may be the consequence of the cataract surgical procedure. Nonocular adverse events reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting and sinusitis

PACKING
5 ml Vial with dispensing plug and screw cap, all polypropylene

Storage :
Store in a cool & dry place. Protect from light. Do not allow to freeze. Keep out of reach of children. Use this solution within one month after opening the container

Medicine :
Keep out of reach of children.
Use the solution within one month after opening the container.
For external use only.