Nevanac
nepafenac
nepafenac
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 NEVANAC is and what it is used for
What you need to know before you use NEVANAC
How to use NEVANAC
Possible side effects
How to store NEVANAC
Contents of the pack and other information
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.
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.
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
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”)
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.
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.
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.
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.
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.
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.
One drop in the affected eye or eyes, three times a day - morning, midday, and evening. Use at the same time each day.
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.
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.
Rinse your eye out with warm water. Do not put in any more drops until it is time for your next regular
dose.
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) 3 times daily.
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.
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.
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.
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.
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.
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.
NEVANAC is a liquid (light yellow to light orange suspension) supplied in a pack containing one
5 ml plastic bottle with a screw cap.
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road Dublin 4
Ireland
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:
SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S
Tlf: +45 39 16 84 00
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Novartis Pharma GmbH
Tel: +49 911 273 0
Novartis Pharma B.V.
Tel: +31 88 04 52 111
SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12
Novartis Pharma GmbH Tel: +43 1 86 6570
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Novartis Ireland Limited
Tel: +353 1 260 12 55
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A.
Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690
Novartis Sverige AB
Tel: +46 8 732 32 00
SIA Novartis Baltics Tel: +371 67 887 070
Novartis Ireland Limited Tel: +44 1276 698370