Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
In clinical studies involving 2314 patients receiving NEVANAC the most common adverse reactions were punctate keratitis, foreign body sensation and eyelid margin crusting which occurred in between 0.4% and 0.2% of patients.

Tabulated list of adverse reactions
The following adverse reactions are 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), or not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post-marketing reports.



Adverse reactions
System organ classification
Immune system disorders                       Rare: hypersensitivity
Nervous system disorders                      Rare: dizziness, headache 
Eye disorders                                 Uncommon: keratitis, punctate keratitis, corneal epithelium defect, foreign body sensation in eyes,
eyelid margin crusting,

Rare: iritis, choroidal effusion, corneal deposits, eye pain, ocular discomfort, dry eye, blepharitis, eye irritation, eye pruritus, eye discharge, allergic conjunctivitis, increased lacrimation, conjunctival hyperaemia

Not known: corneal perforation, impaired healing
(cornea), corneal opacity, corneal scar, reduced visual acuity, eye swelling, ulcerative keratitis, corneal thinning, blurred vision,
Vascular disorders                            Not known: blood pressure increased Gastrointestinal disorders                    Rare: nausea
Not known: vomiting
Skin and subcutaneous tissue disorders        Rare: cutis laxa (dermatochalasis), allergic dermatitis

Diabetic patients
In the two clinical studies involving 209 patients, diabetic patients were exposed to NEVANAC treatment for 60 days or greater for the prevention of macular oedema post cataract surgery. The most frequently reported adverse reaction was punctate keratitis which occurred in 3% of patients, resulting in a frequency category of common. The other reported adverse reactions were corneal epithelium defect and allergic dermatitis which occurred in 1% and 0.5% of patients, respectively both adverse reactions with a frequency category of uncommon.

Description of selected adverse reactions

Clinical trial experience for the long-term use of NEVANAC for the prevention of macular oedema post cataract surgery in diabetic patients is limited. Ocular adverse reactions in diabetic patients may occur at a higher frequency than observed in the general population (see section 4.4).

Patients with evidence of corneal epithelial breakdown including corneal perforation should immediately discontinue use of NEVANAC and should be monitored closely for corneal health (see section 4.4).

From post-marketing experience with NEVANAC, cases reporting corneal epithelium defect/disorder have been identified. Severity of these cases vary from non serious effects on the epithelial integrity of the corneal epithelium to more serious events where surgical interventions and/or medical therapy are required to regain clear vision.

Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (eg, 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. When nepafenac is prescribed to a diabetic patient post cataract surgery to prevent macular oedema, the existence of any additional risk factor should lead to reassessment of the foreseen benefit/risk and to intensified patient monitoring.


Paediatric population
The safety and efficacy of NEVANAC in children and adolescents have not been established.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medical product.

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/.