Nevanac

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

1. NAME OF THE MEDICINAL PRODUCT 

 

NEVANAC 1 mg/ml eye drops, suspension 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

1 ml of suspension contains 1 mg nepafenac. 

 

Excipient with known effect 

 

Each ml of suspension contains 0.05 mg of benzalkonium chloride. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Eye drops, suspension 

 

Light yellow to light orange uniform suspension, pH 7.4 (approximately). 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

NEVANAC 1 mg/ml is indicated in adults for: 

 

- Prevention and treatment of postoperative pain and inflammation associated with cataract 

surgery 

- Reduction in the risk of postoperative macular oedema associated with cataract surgery in 

diabetic patients (see section 5.1) 

 

4.2 Posology and method of administration 

 

Posology 

 

Adults, including the elderly 

For the prevention and treatment of pain and inflammation, the dose is 1 drop of NEVANAC in the 

conjunctival sac of the affected eye(s) 3 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 to 120 minutes prior to surgery. 

 

For the reduction in the risk of postoperative macular oedema associated with cataract surgery in 

diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 

3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 

60 days of the postoperative period as directed by the clinician. An additional drop should be 

administered 30 to 120 minutes prior to surgery. 

 

Special populations 

Patients with renal or hepatic impairment 

NEVANAC 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. 

 



3 

Paediatric population 

The safety and efficacy of NEVANAC in children and adolescents have not been established. No data 

are available. Its use is not recommended in these patients until further data become available. 

 

Geriatric population 

No overall differences in safety and effectiveness have been observed between elderly and younger 

patients. 

 

Method of administration 

 

For ocular use. 

 

Patients should be instructed to shake the bottle well before use. After cap is removed, if tamper 

evident snap collar is loose, remove before using product. 

 

If more than one topical ophthalmic medicinal product is being used, the medicinal product must be 

administered at least 5 minutes apart. Eye ointments should be administered last. 

 

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. Patients should be instructed to 

keep the bottle tightly closed when not in use. 

 

If a dose is missed, a single drop should be applied as soon as possible before reverting to regular 

routine. Do not use a double dose to make up for the 1 missed. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

Hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs). 

 

Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid 

or other NSAIDs. 

 

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. 



4 

 

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 medicines. 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 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. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

In vitro studies have demonstrated a very low potential for interaction with other medicinal products 

and protein binding interactions (see section 5.2). 

 

Prostaglandin analogues 

 

There are very limited data on the concomitant use of prostaglandin analogues and NEVANAC. 

Considering their mechanism of action, the concomitant use of these medicinal products is not 

recommended. 

 

Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 

Concomitant use of NEVANAC with medications that prolong bleeding time may increase the risk of 

haemorrhage (see section 4.4). 

 



5 

4.6 Fertility, pregnancy and lactation 

 

Women of childbearing potential 

 

NEVANAC should not be used by women of child bearing potential not using contraception. 

 

Pregnancy 

 

There are no adequate data regarding the use of nepafenac in pregnant women. Studies in animals 

have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Since 

the systemic exposure in non-pregnant women is negligible after treatment with NEVANAC, the risk 

during pregnancy could be considered low. Nevertheless, as inhibition of prostaglandin synthesis may 

negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal 

development. NEVANAC is not recommended during pregnancy. 

 

Breast-feeding 

 

It is unknown whether nepafenac is excreted in human milk. Animal studies have shown excretion of 

nepafenac in the milk of rats. However, no effects on the suckling child are anticipated since the 

systemic exposure of the breast-feeding woman to nepafenac is negligible. NEVANAC can be used 

during breast-feeding. 

 

Fertility 

 

There are no data on the effect of NEVANAC on human fertility. 

 

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. 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

In clinical studies involving 2314 patients receiving NEVANAC 1 mg/ml 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. 

 



6 

System organ classification Adverse reactions 

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. 

 



7 

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. 

 

4.9 Overdose 

 

No toxic effects are likely to occur in case of overdose with ocular use, nor in the event of accidental 

oral ingestion. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Opthalmologicals, Anti-inflammatory agents, non-steroids, ATC code: 

S01BC10 

 

Mechanism of action 

 

Nepafenac is a non-steroidal anti-inflammatory and analgesic prodrug. After topical ocular dosing, 

nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a 

nonsteroidal anti-inflammatory drug. Amfenac inhibits the action of prostaglandin H synthase 

(cyclooxygenase), an enzyme required for prostaglandin production. 

 

Secondary pharmacology 

 

In rabbits, nepafenac has been shown to inhibit blood-retinal-barrier breakdown, concomitant with 

suppression of PGE2 synthesis. Ex vivo, a single topical ocular dose of nepafenac was shown to inhibit 

prostaglandin synthesis in the iris/ciliary body (85%-95%) and the retina/choroid (55%) for up to 

6 hours and 4 hours, respectively. 

 

Pharmacodynamic effects 

 

The majority of hydrolytic conversion is in the retina/choroid followed by the iris/ciliary body and 

cornea, consistent with the degree of vascularised tissue. 

 

Results from clinical studies indicate that NEVANAC eye drops have no significant effect on 

intraocular pressure. 

 

Clinical efficacy and safety 

 

Prevention and treatment of postoperative pain and inflammation associated with cataract surgery 

Three pivotal studies were conducted to assess the efficacy and safety of NEVANAC dosed 3 times 

daily as compared to vehicle and/or ketorolac trometamol in the prevention and treatment of 

postoperative pain and inflammation in patients undergoing cataract surgery. In these studies, study 

medication was initiated the day prior to surgery, continued on the day of surgery and for up to 

2-4 weeks of the postoperative period. Additionally, nearly all patients received prophylactic treatment 

with antibiotics, according to clinical practice at each of the clinical trial sites. 

 

In two double-masked, randomised vehicle-controlled studies, patients treated with NEVANAC had 

significantly less inflammation (aqueous cells and flare) in the early postoperative period through the 

end of treatment than those treated with its vehicle. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


8 

In one double-masked, randomised, vehicle and active-controlled study, patients treated with 

NEVANAC had significantly less inflammation than those treated with vehicle. Additionally, 

NEVANAC was non-inferior to ketorolac 5 mg/ml in reducing inflammation and ocular pain, and was 

slightly more comfortable upon instillation. 

 

A significantly higher percentage of patients in the NEVANAC group reported no ocular pain 

following cataract surgery compared to those in the vehicle group. 

 

Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic 

patients 

Four studies (two in diabetic patients and two in non-diabetic patients) were conducted to assess the 

efficacy and safety of NEVANAC for the prevention of postoperative macular oedema associated with 

cataract surgery. In these studies, study medication was initiated the day prior to surgery, continued on 

the day of surgery and for up to 90 days of the postoperative period. 

 

In 1 double-masked, randomised vehicle-controlled study, conducted in diabetic retinopathy patients, a 

significantly greater percentage of patients in the vehicle group developed macular oedema (16.7%) 

compared to patients treated with NEVANAC (3.2%). A greater percentage of patients treated with 

vehicle experienced a decrease in BCVA of more than 5 letters from day 7 to day 90 (or early exit) 

(11.5%) compared with patients treated with nepafenac (5.6%). More patients treated with 

NEVANAC achieved a 15 letter improvement in BCVA compared to vehicle patients, 56.8% 

compared to 41.9%. respectively, p=0.019. 

 

Paediatric population 

 

The European Medicines Agency has waived the obligation to submit the results of studies with 

NEVANAC in all subsets of the paediatric population in prevention and treatment of post operative 

pain and inflammation associated with cataract surgery and prevention of post surgical macular 

oedema (see section 4.2 for information on paediatric use). 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Following 3 times daily dosing of NEVANAC eye drops in both eyes, low but quantifiable plasma 

concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours 

post-dose, respectively. The mean steady-state plasma Cmax for nepafenac and for amfenac were 

0.310 ± 0.104 ng/ml and 0.422 ± 0.121 ng/ml, respectively, following ocular administration. 

 

Distribution 

 

Amfenac has a high affinity toward serum albumin proteins. In vitro, the percent bound to rat albumin, 

human albumin and human serum was 98.4%, 95.4% and 99.1%, respectively. 

 

Studies in rats have shown that radioactive labelled active substance-related materials distribute 

widely in the body following single and multiple oral doses of 14C-nepafenac. 

 

Studies in rabbits demonstrated that the topically administered nepafenac is distributed locally from 

the front of the eye to the posterior segments of the eye (retina and choroid). 



9 

 

Biotransformation 

 

Nepafenac undergoes relatively rapid bioactivation to amfenac via intraocular hydrolases. 

Subsequently, amfenac undergoes extensive metabolism to more polar metabolites involving 

hydroxylation of the aromatic ring leading to glucuronide conjugate formation. Radiochromatographic 

analyses before and after β-glucuronidase hydrolysis indicated that all metabolites were in the form of 

glucuronide conjugates, with the exception of amfenac. Amfenac was the major metabolite in plasma, 

representing approximately 13% of total plasma radioactivity. The second most abundant plasma 

metabolite was identified as 5-hydroxy nepafenac, representing approximately 9% of total 

radioactivity at Cmax. 

 

Interactions with other medicinal products: 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 3000 ng/ml. Therefore, interactions involving CYP-mediated metabolism of 

concomitantly administered medicinal products are unlikely. Interactions mediated by protein binding 

are also unlikely. 

 

Elimination 

 

After oral administration of 14C-nepafenac to healthy volunteers, urinary excretion was found to be the 

major route of radioactive excretions, accounting for approximately 85% while faecal excretion 

represented approximately 6% of the dose. Nepafenac and amfenac were not quantifiable in the urine. 

 

Following a single dose of NEVANAC in 25 cataract surgery patients, aqueous humour concentrations 

were measured at 15, 30, 45 and 60 minutes post-dose. The maximum mean aqueous humour 

concentrations were observed at the 1 hour time-point (nepafenac 177 ng/ml, amfenac 44.8 ng/ml). 

These findings indicate rapid corneal penetration. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated dose toxicity and genotoxicity. 

 

Nepafenac has not been evaluated in long-term carcinogenicity studies. 

 

In reproduction studies performed with nepafenac in rats, maternally toxic doses ≥10 mg/kg were 

associated with dystocia, increased postimplantation loss, reduced foetal weights and growth, and 

reduced foetal survival. In pregnant rabbits, a maternal dose of 30 mg/kg that produced slight toxicity 

in the mothers showed a statistically significant increase in the incidence of litter malformations. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Mannitol (E421) 

Carbomer 

Sodium chloride 

Tyloxapol 

Disodium edetate 

Benzalkonium chloride 

Sodium hydroxide and/or hydrochloric acid (for pH adjustment) 

Purified water 

 



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6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf-life 

 

2 years. 

 

Discard 4 weeks after first opening. 

 

6.4 Special precautions for storage 

 

Do not store above 30˚C. 

For storage conditions after first opening of the medicinal product, see section 6.3 

 

6.5 Nature and content of container 

 

5 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap 

containing 5 ml suspension. 

 

Carton containing 1 bottle. 

 

6.6 Special precautions for disposal 

 

No special requirements for disposal. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/07/433/001 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 11 December 2007 

Date of latest renewal: 24 September 2012 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency: http://www.ema.europa.eu 

http://www.ema.europa.eu/


11 

1. NAME OF THE MEDICINAL PRODUCT 

 

NEVANAC 3 mg/ml eye drops, suspension 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

1 ml of suspension contains 3 mg nepafenac. 

 

Excipient with known effect 

 

Each ml of suspension contains 0.05 mg benzalkonium chloride 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Eye drops, suspension 

 

Light yellow to dark orange uniform suspension, pH 6.8 (approximately). 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

NEVANAC 3 mg/ml eye drops, suspension is indicated in adults for: 

 

- Prevention and treatment of postoperative pain and inflammation associated with cataract 

surgery 

- Reduction in the risk of postoperative macular oedema associated with cataract surgery in 

diabetic patients (see section 5.1) 

 

4.2 Posology and method of administration 

 

Posology 

 

Adults, including the elderly 

For the prevention and treatment of pain and inflammation, the dose is 1 drop of NEVANAC in the 

conjunctival sac of the affected eye(s) once a day 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 to 120 minutes prior to surgery. 

 

In clinical trials, patients were treated for up to 21 days with NEVANAC 3 mg/ml eye drops, 

suspension (see section 5.1). 

 

For the reduction in the risk of postoperative macular oedema associated with cataract surgery in 

diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) once 

daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of 

the postoperative period as directed by the clinician. An additional drop should be administered 30 to 

120 minutes prior to surgery. 

 

Once-daily dosing with NEVANAC 3 mg/ml eye drops, suspension provides the same total daily dose 

of nepafenac as three-times-daily dosing with NEVANAC 1 mg/ml eye drops, suspension. 

 



12 

Special populations 

Patients with renal or hepatic impairment 

NEVANAC 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. 

 

Paediatric population 

The safety and efficacy of NEVANAC in children and adolescents have not been established. No data 

are available. Its use is not recommended in these patients until further data become available. 

 

Geriatric population 

No overall differences in safety and effectiveness have been observed between elderly 

and younger patients. 

 

Method of administration 

 

For ocular use. 

 

Patients should be instructed to shake the bottle well before use. After cap is removed, if a tamper 

evident snap collar is present and is loose, remove before using product. 

 

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be 

administered at least 5 minutes apart. Eye ointments should be administered last. 

 

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. Patients should be instructed to 

keep the bottle tightly closed when not in use. 

 

If a dose is missed, a single drop should be applied as soon as possible before reverting to regular 

routine. Do not use a double dose to make up for the 1 missed. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

Hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs). 

 

Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid 

or other NSAIDs. 

 

4.4 Special warnings and precautions for use 

 

The medicinal 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. 



13 

 

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 anti-microbial 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. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

In vitro studies have demonstrated a very low potential for interaction with other medicinal products 

and protein binding interactions (see section 5.2). 

 

Prostaglandin analogues 

 

There are very limited data on the concomitant use of prostaglandin analogues and NEVANAC. 

Considering their mechanism of action, the concomitant use of these medicinal products is not 

recommended. 

 



14 

Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 

Concomitant use of NEVANAC with medications that prolong bleeding time may increase the risk of 

haemorrhage (see section 4.4). 

 

4.6 Fertility, pregnancy and lactation 

 

Women of childbearing potential 

 

NEVANAC should not be used by women of child bearing potential not using contraception. 

 

Pregnancy 

 

There are no adequate data regarding the use of nepafenac in pregnant women. Studies in animals 

have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Since 

the systemic exposure in non-pregnant women is negligible after treatment with NEVANAC, the risk 

during pregnancy could be considered low. Nevertheless, as inhibition of prostaglandin synthesis may 

negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal 

development, NEVANAC is not recommended during pregnancy. 

 

Breast-feeding 

 

It is unknown whether nepafenac is excreted in human milk. Animal studies have shown excretion of 

nepafenac in the milk of rats. However, no effects on the suckling child are anticipated since the 

systemic exposure of the breast-feeding woman to nepafenac is negligible. NEVANAC can be used 

during breast-feeding. 

 

Fertility 

 

There are no data on the effect of NEVANAC on human fertility. 

 

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. 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

In clinical studies involving over 1900 patients receiving NEVANAC 3 mg/ml eye drops, suspension, 

the most frequently reported adverse reactions were punctate keratitis, keratitis, foreign body sensation 

in eyes and eye pain which occurred in between 0.4% and 0.1% of patients. 

 

Diabetic patients 

In the two clinical studies involving 594 patients, diabetic patients were exposed to NEVANAC eye 

drops, suspension treatment for 90 days for the prevention of macular oedema post cataract surgery. 

The most frequently reported adverse reaction was punctate keratitis which occurred in 1% of patients, 

resulting in a frequency category of common. The other most frequently reported adverse reactions 

were keratitis and foreign body sensation in eyes which occurred in 0.5% and 0.3% of patients, 

respectively both adverse reactions with a frequency category of uncommon. 

 



15 

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 or post-marketing reports with NEVANAC 3 mg/ml eye drops, 

suspension and NEVANAC 1 mg/ml eye drops, suspension. 

 

System organ classification Adverse reactions 

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 Uncommon: hypertension 

Not known: blood pressure increased 

Gastrointestinal disorders Rare: nausea 

Not known: vomiting 

Skin and subcutaneous tissue disorders Rare: cutis laxa (dermatochalasis), allergic dermatitis 

 

Description of selected adverse reactions 

 

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 1 mg/ml eye drops, suspension, 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. 

 

Paediatric population 

 

The safety and efficacy of NEVANAC in children and adolescents have not been established. 



16 

 

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. 

 

4.9 Overdose 

 

No toxic effects are likely to occur in case of overdose with ocular use, nor in the event of accidental 

oral ingestion. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Ophthalmologicals, anti-inflammatory agents, non-steroids, ATC code: 

S01BC10 

 

Mechanism of action 

 

Nepafenac is a non-steroidal anti-inflammatory and analgesic prodrug. After topical ocular dosing, 

nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a 

nonsteroidal anti-inflammatory drug. Amfenac inhibits the action of prostaglandin H synthase 

(cyclooxygenase), an enzyme required for prostaglandin production. 

 

Secondary pharmacology 

 

In rabbits, nepafenac has been shown to inhibit blood-retinal-barrier breakdown, concomitant with 

suppression of PGE2 synthesis. Ex vivo, a single topical ocular dose of nepafenac was shown to inhibit 

prostaglandin synthesis in the iris/ciliary body (85%-95%) and the retina/choroid (55%) for up to 

6 hours and 4 hours, respectively. 

 

Pharmacodynamic effects 

 

The majority of hydrolytic conversion is in the retina/choroid followed by the iris/ciliary body and 

cornea, consistent with the degree of vascularised tissue. 

 

Results from clinical studies indicate that NEVANAC 3 mg/ml eye drops, suspension have no 

significant effect on intraocular pressure. 

 

Clinical efficacy and safety 

 

Prevention and treatment of postoperative pain and inflammation associated with cataract surgery 

The efficacy and safety of NEVANAC 3 mg/ml in the prevention and treatment of postoperative pain 

and inflammation associated with cataract surgery has been demonstrated in two masked, double 

blind, placebo-controlled clinical trials in a total of 1339 patients. In these studies in which patients 

were dosed daily beginning one day prior to cataract surgery, continued on the day of surgery and for 

the first 14 days of the postoperative period, NEVANAC 3 mg/ml eye drops, suspension demonstrated 

superior clinical efficacy compared to its vehicle in treating postoperative pain and inflammation. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


17 

 

Patients treated with NEVANAC were less likely to have ocular pain and measurable signs of 

inflammation (aqueous cells and flare) in the early postoperative period through to the end of 

treatment than those treated with its vehicle. In the two studies, NEVANAC cleared inflammation at 

day 14 post operation in 65% and 68% of patients compared to 25% and 35% of patients on vehicle. 

Pain free rates in the NEVANAC group were 89% and 91% compared to 40% and 50% of patients on 

vehicle. 

 

Some patients received NEVANAC 3 mg/ml eye drops, suspension for up to 21 days post operation. 

However, efficacy beyond day 14 post operation was not measured. 

 

In addition, in one of the two clinical trials, NEVANAC 3 mg/ml eye drops, suspension dosed once a 

day was non-inferior to NEVANAC 1 mg/ml eye drops, suspension dosed three times a day for the 

prevention and treatment of postoperative pain and inflammation following cataract surgery. 

Inflammation clearing and pain free rates were similar for both products at all postoperative 

evaluations. 

 

Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic 

patients 

Two studies in diabetic patients were conducted to assess the efficacy and safety of NEVANAC 

3 mg/ml eye drops, suspension dosed once a day for the prevention of postoperative macular oedema 

associated with cataract surgery. In these studies, study medication was initiated the day prior to 

surgery, continued on the day of surgery and for up to 90 days of the postoperative period. 

 

In both double-masked, randomised vehicle-controlled studies, conducted in diabetic retinopathy 

patients, a significantly greater percentage of patients in the vehicle group developed macular oedema 

(17.3% and 14.3%) compared to patients treated with NEVANAC 3 mg/ml (2.3% and 5.9%). The 

corresponding percentages in integrated analysis of the 2 studies were 15.9% in vehicle group and 

4.1% in NEVANAC group, p<0.001). A significantly greater percentage of patients achieved 

improvement of 15 or more letters at Day 14 and maintained the improvement through Day 90 in 

NEVANAC 3 mg/ml group (61.7%) compared to vehicle group (43%) in one study; the percentage of 

subjects was similar in the 2 treatment groups for this endpoint in the second study (48.8% in 

NEVANAC group and 50.5% in vehicle group). In integrated analysis of the 2 studies, the percentage 

of subjects with 15 letter improvement at Day 14 and maintained to Day 90 was higher in NEVANAC 

3 mg/ml group (55.4%) compared to vehicle group (46.7%, p=0.003). 

 

Paediatric population 

 

The European Medicines Agency has waived the obligation to submit the results of studies with 

NEVANAC in all subsets of the paediatric population in prevention and treatment of post operative 

pain and inflammation associated with cataract surgery (see section 4.2 for information on paediatric 

use). 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Following one drop of NEVANAC 3 mg/ml eye drops, suspension in both eyes once daily for four 

days, low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the 

majority of subjects 2 and 3 hours post-dose, respectively. The mean steady-state plasma Cmax for 

nepafenac and for amfenac were 0.847 ± 0.269 ng/ml and 1.13 ± 0.491 ng/ml, respectively, following 

ocular administration. 

 

Distribution 

 

Amfenac has a high affinity toward serum albumin proteins. In vitro, the percent bound to rat albumin, 

human albumin and human serum was 98.4%, 95.4% and 99.1%, respectively. 



18 

 

Studies in rats have shown that radioactive labelled active substance-related materials distribute 

widely in the body following single and multiple oral doses of 14C-nepafenac. 

 

Studies in rabbits demonstrated that the topically administered nepafenac is distributed locally from 

the front of the eye to the posterior segments of the eye (retina and choroid). 

 

Biotransformation 

 

Nepafenac undergoes relatively rapid bioactivation to amfenac via intraocular hydrolases. 

Subsequently, amfenac undergoes extensive metabolism to more polar metabolites involving 

hydroxylation of the aromatic ring leading to glucuronide conjugate formation. 

 

Radiochromatographic analyses before and after β-glucuronidase hydrolysis indicated that all 

metabolites were in the form of glucuronide conjugates, with the exception of amfenac. Amfenac was 

the major metabolite in plasma, representing approximately 13% of total plasma radioactivity. The 

second most abundant plasma metabolite was identified as 5-hydroxy nepafenac, representing 

approximately 9% of total radioactivity at Cmax. 

Interactions with other medicinal products: 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 3000 ng/ml. Therefore, interactions involving CYP-mediated metabolism of 

concomitantly administered medicinal products are unlikely. Interactions mediated by protein binding 

are also unlikely. 

 

Elimination 

 

After oral administration of 14C-nepafenac to healthy volunteers, urinary excretion was found to be the 

major route of radioactive excretions, accounting for approximately 85% while faecal excretion 

represented approximately 6% of the dose. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated dose toxicity and genotoxicity. 

 

Nepafenac has not been evaluated in long-term carcinogenicity studies. 

 

In reproduction studies performed with nepafenac in rats, maternally toxic doses ≥10 mg/kg were 

associated with dystocia, increased postimplantation loss, reduced foetal weights and growth, and 

reduced foetal survival. In pregnant rabbits, a maternal dose of 30 mg/kg that produced slight toxicity 

in the mothers showed a statistically significant increase in the incidence of litter malformations. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Boric acid 

Propylene glycol 

Carbomer 

Sodium chloride 

Guar 

Carmellose sodium 

Disodium edetate 

Benzalkonium chloride 

Sodium hydroxide and/or hydrochloric acid (for pH adjustment) 

Purified water 



19 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf-life 

 

18 months 

 

Discard 4 weeks after first opening. 

 

6.4 Special precautions for storage 

 

Do not store above 25°C. Keep bottle in the outer carton in order to protect from light. 

 

For storage conditions after first opening of the medicinal product, see section 6.3 

 

6.5 Nature and content of container 

 

Round or oval low density polyethylene bottle with a dispensing plug and white polypropylene screw 

cap containing 3 ml suspension. The bottle may be presented in a pouch. 

 

Carton containing 1 bottle. 

 

6.6 Special precautions for disposal 

 

No special requirements for disposal. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/07/433/002 

EU/1/07/433/003 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 03 May 2013 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency: http://www.ema.europa.eu 

 

http://www.ema.europa.eu/


20 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 



21 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer responsible for batch release 

 

S.A. Alcon-Couvreur N.V. 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to medical prescription. 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

 Periodic Safety Update Reports 
 

The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent 

updates of the RMP. 

 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 

 Whenever the risk management system is modified, especially as the result of new information 
being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



22 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



23 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

CARTON FOR SINGLE BOTTLE 5 ml 

1. NAME OF THE MEDICINAL PRODUCT

NEVANAC 1 mg/ml eye drops, suspension 

nepafenac 

2. STATEMENT OF ACTIVE SUBSTANCE

1 ml of suspension contains 1 mg nepafenac. 

3. LIST OF EXCIPIENTS

Mannitol E421, carbomer, sodium chloride, tyloxapol, disodium edetate, benzalkonium chloride, 

sodium hydroxide and/or hydrochloric acid and purified water. 

See leaflet for further information. 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, suspension 

1 x 5 ml 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use. 

Read the package leaflet before use. 

Ocular use 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP 

Discard 4 weeks after first opening. 

Opened: 



25 

9. SPECIAL STORAGE CONDITIONS

Do not store above 30˚C. 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF

APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/433/001 1 x 5 ml 

13. BATCH NUMBER

Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription 

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Nevanac 1 mg/ml 

17. UNIQUE IDENTIFIER-2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: 

SN: 

NN: 



26 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDATE PACKAGING UNITS 

BOTTLE LABEL 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

NEVANAC 1 mg/ml eye drops 

nepafenac 

Ocular use 

2. METHOD OF ADMINISTRATION

Read the package leaflet before use. 

3. EXPIRY DATE

EXP 

Opened: 

4. BATCH NUMBER

Lot 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

5 ml 

6. OTHER



27 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

CARTON FOR SINGLE BOTTLE 

1. NAME OF THE MEDICINAL PRODUCT

NEVANAC 3 mg/ml eye drops, suspension 

nepafenac 

2. STATEMENT OF ACTIVE SUBSTANCE

1 ml of suspension contains 3 mg nepafenac. 

3. LIST OF EXCIPIENTS

Boric acid, propylene glycol, carbomer, sodium chloride, guar, carmellose sodium, disodium edetate, 

benzalkonium chloride, sodium hydroxide and/or hydrochloric acid and purified water. 

See leaflet for further information. 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, suspension 

1 x 3 ml 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use. 

Read the package leaflet before use. 

Ocular use 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Once daily 



28 

8. EXPIRY DATE 

 

EXP 

Discard 4 weeks after first opening. 

Opened: 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25˚C. Keep the bottle in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/07/433/002 1 x 3 ml – round bottle 

EU/1/07/433/003 1 x 3 ml – oval bottle 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Nevanac 3 mg/ml 

 



29 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



30 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

BOTTLE LABEL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

NEVANAC 3 mg/ml eye drops 

nepafenac 

Ocular use 

 

 

2. METHOD OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

3 ml 

 

 

6. OTHER 

 



31 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

POUCH 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 

 

NEVANAC 3 mg/ml eye drops 

nepafenac 

Ocular use 

 

 

2. METHOD OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

 

3. EXPIRY DATE 

 

EXP 

 

Discard 4 weeks after first opening. 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

3 ml 

 

 

6. OTHER 

 



32 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



33 

Package leaflet: Information for the user 

 

NEVANAC 1 mg/ml eye drops, suspension 

nepafenac 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What NEVANAC is and what it is used for 

2. What you need to know before you use NEVANAC 

3. How to use NEVANAC 

4. Possible side effects 

5. How to store NEVANAC 

6. Contents of the pack and other information 

 

 

1. What NEVANAC is and what it is used for 

 

NEVANAC contains the active substance nepafenac, and belongs to a group of medicines called 

nonsteroidal anti-inflammatory drugs (NSAIDs). 

 

NEVANAC is to be used by adults: 

- to prevent and relieve eye pain and inflammation following cataract surgery on the eye 
- to reduce the risk of macular oedema (swelling in the back of the eye) following cataract 

surgery on the eye in diabetic patients. 

 

 

2. What you need to know before you use NEVANAC 

 

Do not use NEVANAC 

- if you are allergic to nepafenac or any of the other ingredients of this medicine (listed in 

section 6), 

- if you are allergic to other nonsteroidal anti-inflammatory drugs (NSAID) 

- if you have experienced asthma, skin allergy, or intense inflammation in your nose when using 

other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, 

diclofenac. 

 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before using NEVANAC: 

- if you bruise easily or have bleeding problems or have had them in the past. 
- if you have any other eye disorder (e.g. an eye infection) or if you are using other medicines in 

the eye (especially topical steroids). 

- if you have diabetes. 
- if you have rheumatoid arthritis. 
- if you have had repeated eye surgery within a short period of time. 
 

Avoid sunlight during treatment with NEVANAC 

 



34 

Wearing contact lenses is not recommended after cataract surgery. Your doctor will advise you when 

you can use contact lenses again (see also “NEVANAC contains benzalkonium chloride”) 

 

Children and adolescents 

Do not give this medicine to children and adolescents below 18 years old because the safety and 

efficacy in this population has not been established. 

 

Other medicines and NEVANAC 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

NEVANAC can affect or be affected by other medicines you are using, including other eye drops for 

the treatment of glaucoma. 

 

Also tell your doctor if you are taking medicines that reduce blood clotting (warfarin) or other 

NSAIDs. They may increase the risk of bleeding. 

 

Pregnancy and breast-feeding 

If you are pregnant, or might get pregnant, talk to your doctor before you use NEVANAC. Women 

who may become pregnant are advised to use effective contraception during NEVANAC treatment. 

The use of NEVANAC is not recommended during pregnancy. Do not use NEVANAC unless clearly 

indicated by your doctor. 

 

If you are breast-feeding, NEVANAC may pass into your milk. However, no effects on suckling 

children are anticipated. NEVANAC can be used during breast-feeding. 

 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor or pharmacist for advice before taking this medicine. 

 

Driving and using machines 

Do not drive or use machines until your vision is clear. You may find that your vision is blurred for a 

time just after using NEVANAC. 

 

NEVANAC contains benzalkonium chloride 

 

This medicine contains 0.25 mg benzalkonium chloride in each 5 ml which is equivalent to 

0.05 mg/ml. 

 

The preservative in NEVANAC, bezalkonium chloride, may be absorbed by soft contact lenses and 

may change the colour of the contact lenses. You should remove contact lenses before using this 

medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye 

irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the 

eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to 

your doctor. 

 

 

3. How to use NEVANAC 

 

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure. 

 

Only use NEVANAC for your eyes. Do not swallow or inject. 

 

The recommended dose is 

One drop in the affected eye or eyes, three times a day - morning, midday, and evening. Use at the 

same time each day. 

 



35 

When to take and for how long 

Begin 1 day before cataract surgery. Continue on the day of surgery. Then use it for as long as your 

doctor tells you to. This may be up to 3 weeks (to prevent and relieve eye pain and inflammation) or 

60 days (to prevent the development of macular oedema) after your operation. 

 

How to use 

Wash your hands before you start. 

 

   
1 2 

 

- Shake well before use. 

 Twist off the bottle cap. 

 After cap is removed, if tamper evident snap collar is loose, remove before using product. 

 Hold the bottle, pointing down, between your thumb and fingers. 

 Tilt your head back. 

 Pull down your lower eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and 
your eye. The drop will go in here (picture 1). 

 Bring the bottle tip close to the eye. Do this in front of a mirror if it helps. 

 Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could 
infect the drops. 

 Gently press on the base of the bottle to release one drop of NEVANAC at a time. 

 Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs 
(picture 2). 

 

If you use drops in both eyes, repeat the steps for your other eye. Close the bottle cap firmly 

immediately after use. 

 

If a drop misses your eye, try again. 

 

If you are using other eye drops, wait at least five minutes between using NEVANAC and the other 

drops. 

 

If you use more NEVANAC than you should 

Rinse your eye out with warm water. Do not put in any more drops until it is time for your next regular 

dose. 

 

If you forget to use NEVANAC 

Use a single dose as soon as you remember. If it is almost time for the next dose, leave out the missed 

dose and continue with the next dose of your regular routine. Do not use a double dose to make up for 

a missed dose. Do not use more than one drop in the affected eye(s) 3 times daily. 

 

If you stop using NEVANAC 

Do not stop using NEVANAC without speaking to your doctor first. You can usually carry on using 

the drops, unless you experience serious side effects. If you are worried talk to your doctor or 

pharmacist. 

 

If you have any further questions on the use of this medicine ask your doctor, pharmacist or nurse. 

 

 



36 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects although not everybody gets them. 

 

There may be a higher risk of corneal side effects (eye surface problems) if you have: 

 

- complicated eye surgery 
- repeated eye surgery within a short period of time 
- certain disorders of the surface of the eye, such as inflammation or dry eye 
- certain general disease, such as diabetes or rheumatoid arthritis 
 

Contact your doctor immediately if your eyes become more red or more painful whilst using the drops. 

This may be a result of inflammation on the eye surface with or without loss or damage of cells or an 

inflammation of the coloured part of the eye (iritis). These side effects have been observed in up to 1 

in 100 people. 

 

The following side effects have also been observed with NEVANAC 1 mg/ml eye drops, suspension 

or NEVANAC 3 mg/ml eye drops, suspension, or both. 

 

Uncommon side effects 

(may affect up to 1 in 100 people) 

 

- Effects in the eye: eye surface inflammation with or without loss or damage of cells, foreign 
body sensation in the eyes, eyelid crusting or drooping. 

 

Rare side effects 

(may affect up to 1 in 1,000 people) 

 

- Effects in the eye: iris inflammation, eye pain, eye discomfort, dry eye, eyelid swelling, eye 
irritation, itchy eye, eye discharge, allergic conjunctivitis (eye allergy), increased tear 

production, deposits on the eye surface, fluid or swelling at the back of the eye, eye redness. 

 

- General side effects: dizziness, headache, allergic symptoms (eyelid allergic swelling), nausea, 
skin inflammation, redness and itching. 

 

Side effects with frequency not known (cannot be estimated from the available data) 

 

 Effects in the eye: damage on the surface of the eye such as thinning or perforation, impaired 
healing of the eye, eye surface scar, clouding, reduced vision, eye swelling, blurred vision. 

 

 General side effects: vomiting, increased blood pressure. 
 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

5. How to store NEVANAC 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP. 

The expiry date refers to the last day of that month. 

 

Do not store above 30°C. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


37 

 

Throw away the bottle 4 weeks after first opening, to prevent infections. Write the date of opening on 

the bottle and carton label in the space provided. 

 

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What NEVANAC contains 

- The active substance is nepafenac. One ml of suspension contains 1 mg of nepafenac. 
- The other ingredients are benzalkonium chloride (see section 2), carbomer, disodium edetate, 

mannitol, purified water, sodium-chloride and tyloxapol. 

Tiny amounts of sodium hydroxide and/or hydrochloric acid are added to keep acidity levels 

(pH levels) normal. 

 

What NEVANAC looks like and the contents of the pack 

NEVANAC is a liquid (light yellow to light orange suspension) supplied in a pack containing one 

5 ml plastic bottle with a screw cap. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

S.A. Alcon–Couvreur N.V 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA „Novartis Baltics“ Lietuvos filialas 

Tel: +370 5 269 16 50 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

Nederland 

Novartis Pharma B.V. 

Tel: +31 26 37 82 111 

 



38 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: + 421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

Latvija 

SIA “Novartis Baltics” 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

This leaflet was last revised in 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

 

http://www.ema.europa.eu/


39 

Package Leaflet: Information for the user 

 

NEVANAC 3 mg/ml eye drops, suspension 

nepafenac 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What NEVANAC is and what it is used for 

2. What you need to know before you use NEVANAC 

3. How to use NEVANAC 

4. Possible side effects 

5. How to store NEVANAC 

6. Contents of the pack and other information 

 

 

1. What NEVANAC is and what it is used for 

 

NEVANAC contains the active substance nepafenac, and belongs to a group of medicines called non-

steroidal anti-inflammatory drugs (NSAIDs). 

 

NEVANAC is to be used by adults: 

- To prevent and relieve eye pain and inflammation following cataract surgery on the eye. 
- To reduce the risk of macular oedema (swelling in the back of the eye) following cataract 

surgery on the eye in diabetic patients. 

 

 

2. What you need to know before you use NEVANAC 

 

Do not use NEVANAC 

- if you are allergic to nepafenac or any of the other ingredients of this medicine (listed in 
section 6) 

- if you are allergic to other nonsteroidal anti-inflammatory drugs (NSAID) 
- if you have experienced asthma, skin allergy, or intense inflammation in your nose when using 

other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, 

diclofenac. 

 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before using NEVANAC: 

- if you bruise easily or have bleeding problems or have had them in the past 
- if you have any other eye disorder (e.g. an eye infection) or if you are using other medicines in 

the eye (especially topical steroids) 

- if you have diabetes 
- if you have rheumatoid arthritis 
- if you have had repeated eye surgery within a short period of time. 
 

Avoid sunlight during treatment with NEVANAC. 

 



40 

Wearing contact lenses is not recommended after cataract surgery. Your doctor will advise you when 

you can use contact lenses again (see also “NEVANAC contains benzalkonium chloride”). 

 

Children and adolescents 

Do not give this medicine to children and adolescents below 18 years old because the safety and 

efficacy in this population has not been established. 

 

Other medicines and NEVANAC 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

NEVANAC can affect or be affected by other medicines you are using, including other eye drops for 

the treatment of glaucoma. 

 

Also tell your doctor if you are taking medicines that reduce blood clotting (warfarin) or other 

NSAIDs. They may increase the risk of bleeding. 

 

Pregnancy and breast-feeding 

If you are pregnant, or might get pregnant, talk to your doctor before you use NEVANAC. Women 

who may become pregnant are advised to use effective contraception during NEVANAC treatment. 

The use of NEVANAC is not recommended during pregnancy. Do not use NEVANAC unless clearly 

indicated by your doctor. 

 

If you are breast-feeding, NEVANAC may pass into your milk. However, no effects on breast-fed 

children are anticipated. NEVANAC can be used during breast-feeding. 

 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor or pharmacist for advice before taking this medicine. 

 

Driving and using machines 

Do not drive or use machines until your vision is clear. You may find that your vision is blurred 

temporarily just after using NEVANAC. 

 

NEVANAC contains benzalkonium chloride 

 

This medicine contains 0.15 mg benzalkonium chloride in each 3 ml which is equivalent to 

0.05 mg/ml. 

 

The preservative in NEVANAC, benzalkonium chloride, may be absorbed by soft contact lenses and 

may change the colour of the contact lenses. You should remove contact lenses before using this 

medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye 

irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the 

eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to 

your doctor. 

 

 

3. How to use NEVANAC 

 

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure. 

 

Only use NEVANAC for your eyes. Do not swallow or inject. 

 

The recommended dose is 

One drop in the affected eye or eyes, once a day. Use at the same time each day. 

 



41 

When to take and for how long 

Begin 1 day before cataract surgery. Continue on the day of surgery. Then use it for as long as your 

doctor tells you to. This may be up to 3 weeks (to prevent and relieve eye pain and inflammation) or 

60 days (to prevent the development of macular oedema and to improve vision) after your operation. 

 

How to use 

Wash your hands before you start. 

 

 

 

 

 

 

 

 

 

 

1 2 

 

 Shake well before use. 

 Turn the closed bottle upside down and shake down once before each use. 

 Twist off the bottle cap. 

 After cap is removed, if a tamper evident snap collar is present and is loose, remove before 
using product. 

 Hold the bottle, pointing down, between your thumb and fingers. 

 Tilt your head back. 

 Pull down your lower eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and 
your eye. The drop will go in here (picture 1). 

 Bring the bottle tip close to the eye. Do this in front of a mirror if it helps. 

 Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could 
infect the drops. 

 Gently squeeze the sides of the bottle until one drop is released into your eye (picture 2). 
 

If you use drops in both eyes, repeat the steps for your other eye. It is not necessary to close and shake 

the bottle between administrations for both eyes. Close the bottle cap firmly immediately after use. 

 

If a drop misses your eye, try again. 

 

If you are using other eye drops, wait at least five minutes between using NEVANAC and the other 

drops. 

 

If you use more NEVANAC than you should 

Rinse your eye out with warm water. Do not put in any more drops until it is time for your next regular 

dose. 

 

If you forget to use NEVANAC 

Use a single dose as soon as you remember. If it is almost time for the next dose, leave out the missed 

dose and continue with the next dose of your regular routine. Do not use a double dose to make up for 

a forgotten dose. Do not use more than one drop in the affected eye(s). 

 

If you stop using NEVANAC 

Do not stop using NEVANAC without speaking to your doctor first. You can usually carry on using 

the drops, unless you experience serious side effects. 

 

If you have any further questions on the use of this medicine ask your doctor, pharmacist or nurse. 

 

 



42 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

There may be a higher risk of corneal side effects (eye surface problems) if you have: 

 

- complicated eye surgery 

- repeated eye surgery within a short period of time 

- certain disorders of the surface of the eye, such as inflammation or dry eye 

- certain general diseases, such as diabetes or rheumatoid arthritis. 

 

Contact your doctor immediately if your eyes become more red or more painful whilst using the drops. 

This may be a result of inflammation on the eye surface with or without loss or damage of cells or an 

inflammation of the coloured part of the eye (iritis). These side effects have been observed in up to 1 in 

100 people. 

 

The following side effects have been observed with NEVANAC 3 mg/ml eye drops, suspension or 

NEVANAC 1 mg/ml eye drops, suspension or both. 

 

Uncommon side effects (may affect up to 1 in 100 people) 

 

 Effects in the eye: eye surface inflammation with or without loss or damage of cells, foreign 
body sensation in the eyes, eyelid crusting or drooping. 

 

Rare side effects (may affect up to 1 in 1,000 people) 

 

 Effects in the eye: iris inflammation, eye pain, eye discomfort, dry eye, eyelid swelling, eye 
irritation, itchy eye, eye discharge, allergic conjunctivitis (eye allergy), increased tear 

production, deposits on the eye surface, fluid or swelling at the back of the eye, eye redness. 

 

 General side effects: dizziness, headache, allergic symptoms (eyelid allergic swelling), nausea, 
skin inflammation, redness and itching. 

 

Side effects with frequency not known (frequency cannot be estimated from the available data) 

 

 Effects in the eye: damage of the surface of the eye such as thinning or perforation, impaired 
healing of the eye, eye surface scar, clouding, reduced vision, eye swelling, blurred vision. 

 

 General side effects: vomiting, increased blood pressure. 
 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

5. How to store NEVANAC 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP. 

The expiry date refers to the last day of that month. 

 

Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


43 

Throw away the bottle 4 weeks after first opening, to prevent infections. Write the date of opening on 

the carton label in the space provided. 

 

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What NEVANAC contains 

- The active substance is nepafenac. One ml of suspension contains 3 mg of nepafenac. 
- The other ingredients are boric acid, propylene glycol, carbomer, sodium chloride, guar, 

carmellose sodium, disodium edetate, benzalkonium chloride (see section 2) and purified water. 

Tiny amounts of sodium hydroxide and/or hydrochloric acid are added to keep acidity levels 

(pH levels) normal. 

 

What NEVANAC looks like and contents of the pack 

NEVANAC eye drops, suspension (eye drops) is a liquid (light yellow to dark orange suspension) 

supplied in a plastic bottle with a screw cap. Each bottle may be placed in a pouch. 

 

Each pack contains one bottle of 3 ml. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

S.A. Alcon – Couvreur N.V 

Rijksweg 14 

B-2870 Puurs 

Belgium 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA „Novartis Baltics“ Lietuvos filialas 

Tel: +370 5 269 16 50 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 



44 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

Nederland 

Novartis Pharma B.V. 

Tel: +31 26 37 82 111 

 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: + 421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

Latvija 

SIA “Novartis Baltics” 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

This leaflet was last revised in 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET