Label: Information for the User

NEVANAC 1 mg/ml Eye Suspension

nepafenac

Read this entire label carefully before using this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Table of Contents

1. What NEVANAC is and for what it is used
2. What you need to know before starting to use NEVANAC
3. How to use NEVANAC
4. Possible adverse effects
5. Storage of NEVANAC
6. Contents of the container and additional information

NEVANAC contains the active substance nepafenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

NEVANAC is used in adults:

For the prevention and relief of eye pain and inflammation after cataract surgery in the eye.

For reducing the risk of macular edema (swelling at the back of the eye) after cataract surgery in the eye in diabetic patients.

• If you are allergic to nepafenac or any of the other ingredients in this medication (listed in section 6),
• If you are allergic to other nonsteroidal anti-inflammatory drugs (NSAIDs)
• If you have experienced asthma, skin allergy, or intense nasal inflammation when using other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, and diclofenac.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use NEVANAC.

• If you have a tendency to 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 eye medications (especially corticosteroid eye drops).
• If you have diabetes.
• If you have rheumatoid arthritis.
• If you have had eye surgery several times in a short period.

Avoid exposure to sunlight during treatment with NEVANAC.

Do not use contact lenses after cataract surgery. Your doctor will tell you when you can start using contact lenses again (see also "NEVANAC contains benzalkonium chloride").

Children and Adolescents

Do not use this medication in children and adolescents under 18 years of age as its safety and efficacy have not been established in this population.

Other Medications and NEVANAC

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

NEVANAC may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment.

Inform your doctor if you are using medications that thin the blood (warfarin) or other NSAIDs. These medications may increase the risk of bleeding.

Pregnancy and Breastfeeding

If you are pregnant or may become pregnant, consult your doctor before using NEVANAC. Women of childbearing age are advised to use effective birth control methods during treatment with NEVANAC. Do not use NEVANAC during pregnancy unless clearly indicated by your doctor.

If you are breastfeeding, NEVANAC may pass into breast milk. However, no effects on the infant are expected. NEVANAC can be used during breastfeeding.

If you are pregnant, breastfeeding, or may become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Operating Machines

Do not drive or operate machines until your vision is clear. Immediately after applying NEVANAC, you may notice that your vision becomes blurry.

NEVANAC contains benzalkonium chloride

This medication contains 0.25 mg of benzalkonium chloride in each 5 ml equivalent to 0.05 mg/ml.

NEVANAC contains a preservative, benzalkonium chloride, which can be absorbed by soft contact lenses and may alter the color of the lenses. Remove contact lenses before using this medication and wait 15 minutes before reinserting them. Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases. Consult your doctor if you experience a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use NEVANAC only in your eyes. Do not swallow or inject.

The recommended dose is

One drop in the affected eye or eyes, three times a day, morning, noon, and night. Use it at the same time every day.

When to use and for how long

Start 1 day before cataract surgery. Continue on the day of surgery. Then use it for the period of time your doctor tells you, which may be up to 3 weeks (to prevent and relieve ocular pain and inflammation) or 60 days (to prevent the appearance of macular edema) after your surgery.

How to use

Wash your hands before starting.

• Shake well before use.
• Remove the cap from the bottle.
• After removing the cap, you must remove the safety seal ring before using this medication.
• Hold the bottle, upside down, between your fingers.
• Incline your head back.
• Gently separate your lower eyelid from your eye with a finger, until a pouch forms where the drop should fall (figure 1).
• Bring the tip of the bottle close to your eye. You can use a mirror to help.
• Do not touch your eye, eyelid, nearby areas, or other surfaces with the dropper, as the drops may become contaminated.
• Press gently on the base of the bottle for each drop of NEVANAC to fall.
• Do not squeeze the bottle: it is designed for a gentle pressure on the base to be sufficient (figure 2).

If drops are applied to both eyes, repeat the above steps for the other eye. Tighten the cap on the bottle immediately after using the product.

If a drop falls outside the eye, try again.

If you are using other eye drops, wait at least 5 minutes between applying NEVANAC and the other drops.

If you use more NEVANAC than you should

Contact your doctor for detailed instructions. Do not apply more drops until it is time for the next dose.

If you forget to use NEVANAC

Apply a single dose as soon as you remember. If it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen. Do not use a double dose to make up for the missed dose. Do not apply more than one drop 3 times a day to the affected eye(s).

If you interrupt treatment with NEVANAC

Do not stop treatment with NEVANAC without consulting your doctor. You can usually continue using the eye drops unless the effects are severe. If these effects concern you, consult your doctor or pharmacist.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

You may have a higher risk of experiencing corneal side effects (problems on the surface of the eye) if you have:

• a complicated eye surgery
• multiple eye surgeries in a short period of time
• determined surface eye alterations, such as inflammation or dry eye
• determined diseases such as diabetes or rheumatoid arthritis

Get in touch with your doctor immediately if your eyes become red or if the pain increases while using the drops. This may be a consequence of a surface eye inflammation with or without cell loss or damage, or an inflammation of the colored part of the eye (iritis). These side effects have been observed in up to 1 in 100 people.

Also, with NEVANAC 1 mg/ml eye drops in suspension or NEVANAC 3 mg/ml eye drops in suspension or with both, the following side effects have been observed:

Uncommon(may affect up to 1 in 100 people)

• Eye effects:inflammation of the surface of the eye with or without cell damage or loss, sensation of a foreign body in the eyes, crusts or eyelid drooping.

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

• Eye effects:inflammation of the iris, eye pain, eye discomfort, dry eye, eyelid swelling, eye irritation, eye itching, eye discharge, allergic conjunctivitis (eye allergy), increased tear production, deposits on the surface of the eye, accumulation of fluid or swelling in the back of the eye, eye redness.
• General side effects:dizziness, headache, allergic symptoms (allergic swelling of the eyelids), nausea, itching, skin redness and inflammation.

Frequency not known(frequency cannot be estimated from available data)

• Eye effects:surface eye damage, such as thinning or perforation, worsening of eye healing, surface eye scarring, sensation of haze, reduced vision, eye swelling, blurred vision.
• General side effects:vomiting, increased blood pressure

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

To prevent infections, discard the bottle 4 weeks after the first opening. Write the opening date in the space provided on the label of the bottle and on the box.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

• The active ingredient is nepafenac. One milliliter of suspension contains 1 mg of nepafenac.
• The other components are benzalkonium chloride (see section 2), carbomer, disodium edetate, mannitol, purified water, sodium chloride, and tiloxapol.

Very small quantities of sodium hydroxide and/or hydrochloric acid are added to maintain normal acidity levels (pH levels).

Appearance of the product and contents of the container

NEVANAC is a liquid (a pale yellow to light orange suspension) that is presented in a box containing a 5 ml plastic bottle with a screw cap.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park,

Merrion Road

Dublin 4

Irlanda

Responsible Person

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

Bélgica

Novartais Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Alemania

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Alemania

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Last review date of this leaflet:

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu