Nevanac 1mg eye drops. suspension

Prevention and treatment of pain and inflammation associated with cataract surgery and reduction in the risk of macular oedema associated with cataract surgery.

Use in adults
Use the lowest effective dose for the shortest possible duration of treatment. Instill one drop of NEVANACu00ae Eye drops in 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 for the first 2 weeks of the postoperative period. Treatment can be extended to the first 3 weeks of the postoperative period, as directed by the clinician. An additional drop should be administered 30-120 minutes prior to surgery. Treatment can be extended for up to 60 days to reduce the risk of macular oedema associated with cataract surgery.

Paediatric patients
The efficacy and safety of NEVANACu00ae Eye drops in patients below the age of 18 years has not been established.

Geriatric patients
No dose adjustment is warranted in these patients as no overall difference in safety and efficacy have been observed in this population.

Use in hepatic and renal impairment
NEVANACu00ae Eye drops has not been studied in patients with hepatic disease or renal impairment. Nepafenac is eliminated primarily through biotransformation and the systemic exposure is very low following topical ocular administration. No dose adjustment is warranted in these patients.

Shake well before use. If more than one topical ophthalmic medication is being used, the medicines must 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. Keep the bottle tightly closed when not in use.

Hypersensitivity to the active substance, to any of the excipients, or to other non-steroidal anti-inflammatory drugs (NSAIDs).
Cardiovascular: Heart failure.
Gastrointestinal: History of gastrointestinal bleeding or perforation (PUBu2019s) related to previous NSAIDs, including NEVANACu00ae. Active or history of recurrent ulcer / haemorrhage / perforations. NEVANACu00ae Eye drops is also contra-indicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs.

Use of topical NEVANACu00ae Eye drops may result in keratitis. Continued use of topical NEVANACu00ae Eye drops 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 NEVANACu00ae Eye drops and should be monitored closely for corneal health.

Topical NEVANACu00ae Eye drops may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of NEVANACu00ae Eye drops and topical steroids may increase the potential for healing problems.

In view of the productu2019s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

Post-marketing experience with topical NSAIDs such as NEVANACu00ae 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. NEVANACu00ae Eye drops should be used with caution in these patients. Prolonged use of NEVANACu00ae Eye drops may increase patient risk for occurrence and severity of corneal adverse reactions.

NEVANACu00ae may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. NEVANACu00ae Eye drops should be used with caution in patients with known bleeding tendencies or who are receiving other medicines which may prolong bleeding time.

NEVANACu00ae Eye drops contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses. Additionally, 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 NEVANACu00ae Eye drops.

Benzalkonium chloride, used as a preservative in NEVANACu00ae, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since NEVANACu00ae Eye drops contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.

An acute ocular infection may be masked by the topical use of NEVANACu00ae. NEVANACu00ae does not have antimicrobial properties. In case of ocular infection, NEVANACu00ae should be used with care with anti-infectives.

Cardiovascular: Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NEVANACu00ae Eye drops therapy. In view of NEVANACu2019su00ae inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

Gastrointestinal: Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation (PUBs) which may be fatal. The risk of gastrointestinal bleeding or perforation is higher with increasing doses of NEVANACu00ae Eye drops, in patients with a history of ulcers and the elderly. When gastrointestinal bleeding or ulceration occurs in patients receiving NEVANACu00ae Eye drops, treatment with NEVANACu00ae Eye drops should be stopped. NEVANACu00ae Eye drops should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohnu2019s disease, hiatus hernia, gastro - oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.

Skin Reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. NEVANACu00ae Eye drops should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Cross-sensitivity: There is a potential for cross-sensitivity of NEVANACu00ae Eye drops to aspirin, phenylacetic acid derivatives, and other NSAIDs.

Neither nepafenac nor amfenac inhibit any of the major human cytochrome P450 (CYP1A2, 2C9, 2C19, 2D6, 2E1 and 3A4) metabolic activities in vitro at concentrations up to 300 ng/ml. Therefore, interactions involving CYP-mediated metabolism of concomitantly administered medicines are unlikely. In vitro studies have demonstrated a low potential for interactions. Interactions mediated by protein binding are also unlikely.

Use of NEVANACu00ae with another NSAID concomitantly could result in an increase in side effects.

Gastrointestinal: Corticosteroids: increased risk of gastrointestinal perforation ulceration or bleeding (PUBs). Anti-coagulants: NEVANACu00ae Eye drops may enhance the effects of anti-coagulants such as warfarin. Anti-platelet medicines and selective serotonin reuptake inhibitors (SSRIs): increased risk of intestinal bleeding. NEVANAC eye drops may be administered in conjunction with other topical ophthalmic medicines such as beta- blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics and mydriatics.

Pregnancy
NEVANACu00ae Eye drops should not be used during pregnancy. NEVANACu00ae is contraindicated in the third trimester of pregnancy. There are no adequate data from the use of NEVANACu00ae Eye drops in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. As inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal development.

Regular use of non-steroidal anti-inflammatory drugs during the 3rd trimester of pregnancy, may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased.

Lactation
It is unknown whether NEVANACu00ae Eye drops is excreted in human milk. Animal studies have shown excretion of NEVANACu00ae Eye drops in the milk of lactating rats. NEVANACu00ae Eye drops should not be used in women breastfeeding their infants.

If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.

In clinical studies involving over 800 patients receiving NEVANACu00ae Eye drops, approximately 5 % of patients experienced adverse reactions. These events led to discontinuation in 0,5 % of patients, which was less than placebo-treated patients (1,3 %) in these same studies. No serious adverse events related to NEVANACu00ae Eye drops were reported in these studies.

The following undesirable effects were assessed to be treatment-related and are classified according to the following convention: very common (u22651/10), common (u22651/100 to <1/10), uncommon (u22651/1,000 to <1/100), rare (u22651/10,000 to <1/1000) or very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Immune system disorders
Rare: hypersensitivity.

Nervous system disorders
Rare: headache, dizziness.

Eye disorders
Uncommon: keratitis, allergic conjunctivitis, punctate keratitis, eye pain, foreign body sensation in eyes, eyelid margin crusting. Rare: Blurred vision, eye pruritus, dry eye, eye discharge, photophobia, eye irritation, increased lacrimation, blepharitis.

Gastrointestinal disorders
Rare: nausea.

Skin and subcutaneous tissue disorders
Rare: Allergic dermatitis.

Post marketing
Additional adverse reactions identified from post-marketing surveillance include the following. Frequencies cannot be estimated from the available data. Within each System Organ Class adverse reactions are presented in order of decreasing seriousness.

System Organ Classification Adverse reactions MedDRA Preferred Term (v. 18.0)

Eye disorders corneal perforation, ulcerative keratitis, corneal thinning, corneal opacity, corneal abrasion, corneal scar, impaired healing (cornea), visual acuity reduced, eye swelling, ocular hyperaemia.

Gastrointestinal disorders vomiting.

Investigations blood pressure increased.

There is no experience of overdose with ocular use. The application of more than one drop per eye is unlikely to lead to unwanted side-effects. There is practically no risk of adverse effects due to accidental oral ingestion.