NEVANAC 1 mg/ml eye drops, suspension

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).

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.

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, NEVANACmay 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.

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 useNEVANAC 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 handsbefore you start.

2 1 Shake well before use. Twist off the bottle cap.

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.

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)

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
• 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

If any of the side effects gets serious or if you notice any side effects not listed, please tell your doctor or pharmacist.

Keep outof 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.

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 andor hydrochloric acid are added to keep acidity levels pH levels normal.

What NEVANAClooks 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

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

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

Lietuva Alcon Pharmaceuticals Ltd. atstovyb 370 5 2 314 756 BelgiëBelgiqueBelgien LuxembourgLuxemburg SA Alcon-Couvreur NV 32 03 890 27 11 BelgiëBelgiqueBelgien

359 2 950 15 65 Magyarország Alcon Hungária Gyógyszerkereskedelmi Kft. 36-1-463-9080

eská republika Alcon Pharmaceuticals Czech Republic s.r.o. 420 225 377 333 Nederland Alcon Nederland BV 31 0 183 654321

Danmark Alcon Danmark AS 45 3636 3434 Norge Alcon Norge AS 47 23 25 25 50

Deutschland Alcon Pharma GmbH 49 0761 1304-0 Österreich Alcon Ophthalmika GmbH 43 01 596 69 70

Polska Alcon Polska Sp. z o.o. 48 22 820 3450 30 210 68 78 300

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 01 47 10 47 10 Slovenija Alcon d.o.o. 386 1 422 5280

Slovenská republika Alcon Pharmaceuticals Ltd oz 421 2 5441 0378 Ireland Malta United Kingdom Alcon Laboratories UK Ltd. 44 0 1442 34 1234 United Kingdom

Ísland Alcon Danmark AS 45 3636 3434 SuomiFinland Alcon Finland Oy 358 207 871 600

Italia Alcon Italia S.p.A. 39 02 81803.1 Sverige Alcon Sverige AB 46 08 634 40 00 E-post receptionenalconlabs.com

Latvija

Alcon Pharmaceuticals Ltd
- + 371 7 321 121

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