Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

The product should not be injected. Patients should be instructed not to swallow NEVANAC.
Patients should be instructed to avoid sunlight during treatment with NEVANAC.

Ocular effects
Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation (see section 4.8). These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of NEVANAC and should be monitored closely for corneal health.

Topical NSAIDs 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. Therefore, it is recommended that caution should be exercised if NEVANAC is administered concomitantly with corticosteroids, particularly in patients at high risk for corneal adverse reactions described below.

Post-marketing 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 reactions which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Prolonged use of topical NSAIDs may increase patient risk for occurrence and severity of corneal adverse reactions.


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

An acute ocular infection may be masked by the topical use of anti-inflammatory medicinal products.
NSAIDs do not have any antimicrobial properties. In case of ocular infection, their use with anti-infectives should be undertaken with care.

Contact lenses
Contact lens wear is not recommended during the postoperative period following cataract surgery.
Therefore, patients should be advised not to wear contact lenses unless clearly indicated by their doctor.

Benzalkonium chloride
NEVANAC contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. If contact lenses need to be used during treatment, patients should be advised to remove contact lenses prior to application and wait at least 15 minutes before reinsertion.
Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since NEVANAC contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.

Cross-sensitivity
There is a potential for cross-sensitivity of nepafenac to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.

Effects on Driving

4.7   Effects on ability to drive and use machines
NEVANAC has no or negligible influence on the ability to drive and use machines.
Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.