1 mg / ml eye drops , suspension
nepafenac
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 used in adults for:
- to prevent and relieve eye pain and inflammation after cataract surgery in the eye
- to reduce the risk of macular edema (swelling in the posterior parts of the eye) after cataract surgery in the eye in diabetic patients.
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 non-steroidal anti-inflammatory drugs ( NSAIDs ).
- if you have had asthma , skin allergies or intense inflammation of the nose after using other NSAIDs . Examples of other NSAIDs are acetylsalicylic acid , ibuprofen , ketoprofen , piroxicam and diclofenac .
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Nevanac if you
- easily get bruises or suffer from bleeding problems or have previously had these problems
- suffer from another eye disease (eg an eye infection ) or if you are taking other medicines in the eye (especially steroids for eye use)
- have diabetes
- have rheumatism
- have undergone repeated eye surgeries within a short time
Avoid sunlight when treated with Nevanac.
The use of contact lenses is not recommended after cataract surgery. Your doctor will tell you when you can wear contact lenses again (see also section “Nevanac contains benzalkonium chloride”).
Children and young people
Do not give this medicine to children and adolescents under 18 years of age as safety and efficacy have not been established in this age group.
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 use, including other eye drops for the treatment of glaucoma.
Also, tell your doctor if you are taking medicines that reduce the blood’s ability to coagulate ( warfarin ) or other NSAIDs. They may increase the risk of bleeding.
Pregnancy and breastfeeding
If you are pregnant or think you may be pregnant, ask your doctor for advice before using Nevanac. Women who may become pregnant are advised to use effective contraception during treatment with Nevanac. The use of Nevanac during pregnancy is not recommended. Do not use Nevanac unless your doctor tells you to.
If you are breastfeeding, Nevanac may pass into breast milk. However, no effects on breastfed infants are expected. Nevanac can be used during breastfeeding.
If you are pregnant or breastfeeding, 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 becomes blurred just after using Nevanac.
Nevanac contains benzalkonium chloride
This medicine contains 0.25 mg of benzalkonium chloride per 5 ml corresponding to 0.05 mg/ml.
The preservative in Nevanac, benzalkonium chloride, can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses. Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
How to use Nevanac
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Use Nevanac only as eye drops. Do not swallow or inject.
The recommended dose is
One drop in the affected eye or eyes three times daily – morning, mid-day, and evening. Use the eye drops at the same time each day.
When to use Nevanac and for how long
Start one day before eye surgery. Continue during the day of surgery. Then use Nevanac for as long as your doctor prescribes it. This can be up to 3 weeks (to prevent and relieve pain and inflammation in the eye) or 60 days (to prevent macular edema) after surgery.
Instructions for use
Wash your hands before you start.
- Shake the bottle carefully.
- Unscrew the hat.
- If the safety collar is loose when the cover has been removed, it must be removed before using the product.
- Hold the bottle upside down between your thumb and the other fingers.
- Tilt your head back.
- Pull down the lower eyelid with a clean finger, so that a pocket is formed between the eyelid and the eye. The drop should end up in the pocket (Fig. 1).
- Move the tip of the bottle close to the eye. Use a mirror if it makes it easier.
- Do not touch the eye or eyelid, surrounding areas or other surfaces with the bottle tip. This can contaminate the drops.
- Gently press the bottom of the bottle with your index finger to release one drop of Nevanac at a time.
- Do not squeeze the bottle; it is designed so that a light pressure at the bottom is sufficient (Fig. 2).
If you drip in both eyes, repeat all the steps in the other eye. Screw the cap onto the bottle firmly immediately after use.
If the drop misses the eye, try again.
If you use other eye drops, wait at least five minutes between the use of Nevanac and the other drops.
If you use more Nevanac than you should
Rinse everything with lukewarm water. Do not drip in more drops until it is time for your next dose.
If you forget to use Nevanac
Then use a drop of the medicine as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your normal routine. Do not take a double dose to make up for a forgotten dose. Do not use more than one drop on the affected eye 3 times daily.
If you stop using Nevanac
Do not stop using Nevanac without talking to your doctor first. You can usually continue to take the drops unless the side effects are severe. If you have any further questions, ask your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may be at greater risk for eye surface problems if you have had:
- complicated eye surgery
- recurrent eye surgery for a short period of time
- certain diseases of the surface of the eye such as inflammation or dry eyes
- certain common diseases such as diabetes or rheumatism
Contact a doctor immediately if your eyes become redder or more painful when you use the drops.
It may be due to a superficial eye inflammation with or without loss of or damage to cells or inflammation of the colored part of the eye ( iritis ). These side effects have been observed in up to 1 in 100 users.
The following side effects have also been observed with the use of Nevanac 1 mg/ml eye drops, suspension or Nevanac 3 mg/ml eye drops, suspension , or both:
Uncommon (may affect up to 1 in 100 people)
- Eye effects : inflammation of the surface of the eye with or without cell loss or cell damage, feeling of debris in the eye, crusts on the eyelids or drooping eyelids
Rare (may affect up to 1 in 1,000 users)
- Eye effects : iris inflammation, eye pain, eye discomfort, dry eyes, swollen eyelids, eye irritation, eye itching, secretion from the eye, allergic conjunctivitis (eye allergy), increased tear production, deposits on the surface of the eye, fluid or swelling in the back of the eye, red eyes.
- General side effects include : dizziness, headache, allergic symptoms (swelling of the eyelids), nausea, dermatitis, redness and itching .
Side effects with unknown frequency (can not be calculated from the available data)
- Eye effects : damage to the surface of the eye such as thinning or the appearance of holes, impaired healing of the eye, scars on the surface of the eye, cloudiness, impaired vision, eye swelling, blurred vision.
- General side effects include : vomiting, high blood pressure .
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 carton and bottle after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Discard the bottle 4 weeks after opening to prevent infection. Write down the date you opened the bottle in the space on the box and the bottle.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- 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.
- Small amounts of sodium hydroxide and / or hydrochloric acid may have been used to keep the acidity ( pH ) normal.
What the medicine looks like and contents of the pack
Nevanac is a liquid (light yellow to light orange suspension ) supplied in a 5 ml plastic bottle with a screw cap.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
SA Alcon Couvreur NV
Rijksweg 14
2870 Puurs
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: + 421 2 5542 5439 |
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| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370 |