ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NEVANAC 1 mg/ml eye drops, suspension
2.
1 ml of suspension contains 1 mg nepafenac.
Excipients: benzalkonium chloride 0.05 mg.
For a full list of excipients, see section 6.1.
3.
Eye drops, suspension (eye drops)
Light yellow to light orange uniform suspension, pH 7.4 (approximately).
4.
4.1
Prevention and treatment of postoperative pain and inflammation associated with cataract surgery (see
section 5.1).
4.2
Use in adults, including the elderly
The dose is one 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 30-120 minutes prior to surgery.
Paediatric patients
NEVANAC is not recommended for use in children below 18 years due to a lack of data on safety and
efficacy.
Use in hepatic and renal 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.
Method of administration
For ocular use.
Instruct patients to shake the bottle well before use.
If more than one topical ophthalmic medicinal product 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. Instruct patients to keep the
bottle tightly closed when not in use.
2
4.3
Hypersensitivity to the active substance, to any of the excipients, or to other nonsteroidal
anti-inflammatory drugs (NSAIDs).
Like other NSAIDs, NEVANAC is also contraindicated in patients in whom attacks of asthma,
urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.
4.4
Do not inject. Instruct patients not to swallow NEVANAC.
Instruct patients to avoid sunlight during treatment with NEVANAC.
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. 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.
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. Use NEVANAC with caution in patients
with known bleeding tendencies or who are receiving other medicinal products which may prolong
bleeding time.
There are no data on the concomitant use of prostaglandin analogues and NEVANAC. Considering
their mechanisms of action, the concomitant use of these medicinal products is not recommended.
NEVANAC 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 NEVANAC.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, 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.
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.
Cross-sensitivity
There is a potential for cross-sensitivity of nepafenac to acetylsalicylic acid, phenylacetic acid
derivatives, and other NSAIDs.
3
4.5
In vitro
studies have demonstrated a very low potential for interaction with other medicinal products
and protein binding interactions (see section 5.2).
4.6
Pregnancy
There are no adequate data from 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 unless the benefit outweighs the
potential risk.
Lactation
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 breastfeeding woman to nepafenac is negligible. NEVANAC can be used
during lactation.
4.7
As with any eye drops, 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 machinery.
4.8
In clinical studies involving over 800 patients receiving NEVANAC 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 NEVANAC 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 (≥1/10), common (≥1/100 to <1/10), uncommon
(≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare <1/10,000). Within each frequency
grouping, undesirable effects are presented in order of decreasing seriousness.
Nervous system disorders
Common:
headache
Eye disorders
Common:
punctate keratitis, eye pain, blurred vision, eye pruritus, dry eye, foreign body
sensation in eyes, eyelid margin crusting
Uncommon:
iritis, keratitis, corneal deposits, choroidal effusion, eye discharge,
photophobia, eye irritation, allergic conjunctivitis, ocular discomfort, eyelid
disorder, increased lacrimation, conjunctival hyperaemia
Gastrointestinal disorders
Uncommon:
nausea, dry mouth
Skin and subcutaneous tissue disorders
Uncommon:
cutis laxa (dermatochalasis)
4
Immune system disorders
Uncommon:
hypersensitivity
Adverse reactions identified from post-marketing experience that have not been reported previously in
clinical trials with NEVANAC include the following. The frequency category in which these adverse
reactions occur is not known and cannot be estimated from the available data.
Eye disorders
:
ulcerative keratitis, corneal epithelium defect/disorder, corneal abrasion,
anterior chamber inflammation, impaired healing (cornea), reduced visual
acuity, corneal scar, corneal opacity
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of
NEVANAC
and should be monitored closely for corneal health (see section 4.4).
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.
4.9
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.
5.
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: Antiinflammatory 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 PGE
2
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.
5
Clinical Effects
Three pivotal studies were conducted to assess the efficacy and safety of NEVANAC dosed 3 times
daily as compared to placebo 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 placebo-controlled studies, patients treated with NEVANAC had
significantly less inflammation (aqueous cells and flare) from the early postoperative period through
the end of treatment than those treated with placebo.
In one double-masked, randomised, placebo-and active-controlled study, patients treated with
NEVANAC had significantly less inflammation than those treated with placebo. 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 placebo group.
5.2
Pharmacokinetic properties
Absorption
Following three-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 C
max
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
14
C-nepafenac.
Metabolism
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 C
max
.
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 300 ng/ml. Therefore, interactions involving CYP-mediated metabolism of
concomitantly administered medicinal products are unlikely. Interactions mediated by protein binding
are also unlikely.
Excretion/Elimination
After oral administration of
14
C-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.
6
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 upon 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.
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
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.
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.
7
Alcon Laboratories (UK) Ltd.
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom
8.
EU/1/07/433/001
9.
Date of first authorisation: 11/12/07
10.
Detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu
8
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
9
A.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturerresponsible for batch release
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
B. CONDITIONS OF THE MARKETING AUTHORISATION
Medicinal product subject to medical prescription.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the
Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Risk Management Plan
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in
the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented
in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP
agreed by the CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the
updated RMP should be submitted at the same time as the next Periodic Safety Update Report
(PSUR).
In addition, an updated RMP should be submitted:
When new information is received that may impact on the current Safety Specification,
Pharmacovigilance Plan or risk minimisation activities
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
reached
At the request of the European Medicines Agency
10
ANNEX III
LABELLING AND PACKAGE LEAFLET
11
A. LABELLING
12
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR SINGLE BOTTLE 5 ml
1.
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 (to adjust pH) and purified water.
See leaflet for further information.
4.
Eye drops, suspension
1 x 5 ml
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Ocular use.
Shake well before use.
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP:
Discard 4 weeks after first opening.
Opened:
13
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
Alcon Laboratories (UK) Ltd.
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom
EU/1/07/433/001 1 x 5 ml
13. MANUFACTURER’S BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
nevanac
14
PARTICULARS TO APPEAR ON SMALL IMMEDATE PACKAGING UNITS
BOTTLE LABEL
1.
NEVANAC 1 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.
Opened:
4.
BATCH NUMBER
Lot:
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
5 ml
6.
OTHER
15
B. PACKAGE LEAFLET
16
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.
Keep this leaflet.
You may need to read it again. If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What NEVANAC is and what it is used for
2. Before you use NEVANAC
3. How to use NEVANAC
4. Possible side effects
5. How to store NEVANAC
6. Further information
1.
WHAT NEVANAC IS AND WHAT IT IS USED FOR
NEVANAC is used to prevent and relieve eye pain and inflammation following cataract surgery on
the eye.
NEVANAC belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
2.
BEFORE YOU USE NEVANAC
Do not use NEVANAC
if you are allergic (hypersensitive) to nepafenac or any of the other ingredients in NEVANAC or to
other nonsteroidal anti-inflammatory drugs
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.
Take special care with NEVANAC
In children.
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
Tell your doctor if any of these apply.
You may still be able to use NEVANAC, but discuss it with
your doctor first.
17
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines
,
including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, or might get pregnant, talk to your doctor before you use NEVANAC.
If you are breast-feeding, NEVANAC
may pass into your milk.
Ask your doctor for advice before taking any 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.
Important information about some of the ingredients
There is a preservative in NEVANAC (benzalkonium chloride) that can discolour soft lenses and
may cause eye irritation. Additionally, wearing contact lenses is not recommended after cataract
surgery.
Therefore, do not wear contact lenses
whilst using NEVANAC.
3.
HOW TO USE NEVANAC
Always use NEVANAC exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Only use NEVANAC in both eyes if your doctor has told you to.
Only use
NEVANAC as an eye drop.
The usual dose
Adults: One drop in the affected eye or eyes, three times a day-morning, midday, and evening. Use at
the same time each day.
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 after your operation.
How to use
Wash your hands
before you start.
1
2
Shake well before use.
Twist off the bottle cap.
18
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.
Now turn over>
How to use:
see also
side 1
If a drop misses your eye, try again.
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 are using other eye drops, wait at least five minutes between using NEVANAC and the other
drops.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines NEVANAC can cause side effects although not everybody gets them.
Do not stop taking NEVANAC without speaking to your doctor. You can usually carry on using the
drops, unless the effects are serious. If you are worried, talk to your doctor or pharmacist.
If your eyes get redder or more painful while using the drops:
Contact your doctor immediately.
Common side effects
(1 to 10 users in 100).
Effects in the eye: eye surface inflammation with loss or damage of cells, eye pain, blurred vision,
itchy eye, dry eye, foreign body sensation in the eyes, eyelid crusting
General side effects: headache
Uncommon side effects
(1 to 10 users in 1,000)
19
Effects in the eye: inflammation of the coloured part of the eye (iritis), eye surface inflammation,
deposits on the eye surface, fluid or swelling at the back of the eye, eye discharge, sensitivity to light,
allergic conjunctivitis (eye allergy), eye irritation or pain, eyelid disorder (swelling) or drooping,
increased tear production, eye redness
General side effects: allergic symptoms, nausea, dry mouth
Additional side effects
may also affect people using NEVANAC including:
Effects in the eye: eye surface scar, scratch, clouding, inflammation or infection, inflammation inside
the eye, impaired healing of the eye, reduced vision.
You may be at a higher risk for eye surface problems that could result in loss of vision if you have
had:
•
complicated eye surgery
•
certain disorders of the surface of the eye, such as inflammation or dry eye
•
certain general diseases, such as diabetes or rheumatoid arthritis
If any of the side effects gets serious or if you notice any side effects not listed, please tell your doctor
or pharmacist.
5.
HOW TO STORE NEVANAC
Keep out
of the reach and sight of children.
Do not use NEVANAC 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.
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.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help protect the environment.
6.
FURTHER INFORMATION
What NEVANAC contains
The active substance is nepafenac. One ml of suspension contains 1 mg of nepafenac.
The other ingredients are
benzalkonium chloride, 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.
20
•
repeated eye surgery within a short period of time
Marketing Authorisation Holder
Alcon Laboratories (UK) Ltd.
Boundary Way
Hemel Hempstead
Herts, HP2 7UD
United Kingdom.
Manufacturer
S.A. Alcon-Couvreur N.V
Rijksweg 14
B-2870 Puurs
Belgium
21
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.
België/Belgique/Belgien
Luxembourg/Luxemburg
SA Alcon-Couvreur NV
+ 32 (0)3 890 27 11 (België/Belgique/Belgien)
Lietuva
Alcon Pharmaceuticals Ltd. atstovybė
+ 370 5 2 314 756
България
Алкон България ЕООД
+ 359 2 950 15 65
Magyarország
Alcon Hungária Gyógyszerkereskedelmi Kft.
+ 36-1-463-9080
Česká republika
Alcon Pharmaceuticals (Czech Republic) s.r.o
.
+ 420 225 377 333
Nederland
Alcon Nederland BV
+ 31 (0) 183 654321
Danmark
Alcon Danmark A/S
+ 45 3636 3434
Norge
Alcon Norge AS
+ 47 23 25 25 50
Deutschland
Alcon Pharma GmbH
+ 49 (0)761 1304-0
Österreich
Alcon Ophthalmika GmbH
+ 43 (0)1 596 69 70
Ελλάδα
Κύπρος
Άλκον Λαμποράτορις Ελλάς ΑΕΒΕ
+ 30 210 68 78 300 (Ελλάδα)
Polska
Alcon Polska Sp. z o.o.
+ 48 22 820 3450
Eesti
Alcon Eesti
+ 372 6 313 214
Portugal
Alcon Portugal – Produtos e Equipamentos
Oftalmológicos, Lda.
+ 351 214 400 300
España
Alcon Cusí, S.A.
+ 34 93 497 7000
România
S.C. Alcon Romania S.R.L..
: + 40 21 203 93 24
France
Laboratoires Alcon
+ 33 (0)1 47 10 47 10
Slovenija
Alcon d.o.o.
+ 386 1 422 5280
Ireland
Malta
United Kingdom
Alcon Laboratories (UK) Ltd.
+ 44 (0) 1442 34 1234 (United Kingdom)
Slovenská republika
Alcon Pharmaceuticals Ltd – oz
+ 421 2 5441 0378
Ísland
Alcon Danmark A/S
+ 45 3636 3434
Suomi/Finland
Alcon Finland Oy
+ 358 207 871 600
22
Italia
Alcon Italia S.p.A.
+ 39 02 81803.1
Sverige
Alcon Sverige AB
+ 46 (0)8 634 40 00
E-post: receptionen@alconlabs.com
Latvija
Alcon Pharmaceuticals Ltd
+ 371 7 321 121
This leaflet was last approved in
Detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu
23
Source: European Medicines Agency
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