Label: information for the user

NEVANAC 3 mg/ml eye drop suspension

nepafenac

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they 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.

Label 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 (inflammation in 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 components of 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 use contact lenses again. 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 also 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 who may become pregnant should 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 Using Machines

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

NEVANAC contains benzalkonium chloride

This medication contains 0.15 mg of benzalkonium chloride in each 3 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 feel 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, once a day. Use it at the same time every day.

When to use and for how long

Start 1 day before cataract surgery. Continue during 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 eye pain and inflammation) or 60 days (to prevent macular edema and improve vision) after your surgery.

How to use

Wash your hands before starting.

• Shake well before use.
• Place the closed bottle upside down and shake it once before each use.
• Twist off the bottle cap.
• After removing the cap, the safety seal ring must be removed if present and loose before using this medication.
• Hold the bottle, upside down, between your fingers.
• Tilt 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 for help.
• Do not touch your eye, eyelid, nearby areas, or other surfaces with the dropper, as the drops may become contaminated.
• Press the sides of the bottle gently until a drop falls into your eye (figure 2).

If you apply drops to both eyes, repeat the above steps for the other eye. It is not necessary to close and shake the bottle between administrations for both eyes. Tighten the cap well 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 the application of 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 forgot 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 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 drop unless the effects are severe.

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
• specific surface eye alterations, such as inflammation or dry eye
• specific 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 corneal inflammation with or without cell loss or damage, or iris inflammation. These side effects have been observed in up to 1 in 100 people.

The following side effects have been observed with NEVANAC 3 mg/ml suspension eye drops or NEVANAC 1 mg/ml suspension eye drops or with both:

Uncommon(may affect up to 1 in 100 people)

• Eye effects:corneal inflammation 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:iris inflammation, eye pain, eye discomfort, dry eye, eyelid swelling, eye irritation, eye itching, eye discharge, allergic conjunctivitis (eye allergy), increased tearing, 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:eye surface damage, such as thinning or perforation, impaired eye healing, eye surface scar, 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 25°C. Store the bottle in the outer packaging to protect it from light.

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

Medicines 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 will help protect the environment.

• The active ingredient is nepafenac. One milliliter of suspension contains 3 mg of nepafenac.
• The other components are boric acid, propylene glycol, carbomer, sodium chloride, guar powder, sodium carmellose, disodium edetate, benzalkonium chloride (see section 2) and purified water. 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 eye drops in suspension (eye drops) is a liquid (a pale yellow to dark orange suspension) that is presented in a plastic bottle with a screw cap. The bottle may be found inside a bag.

Each container contains a 3 ml bottle.

Marketing authorization holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Irlanda

Responsible for manufacturing

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

Bélgica

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Alemania

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Alemania

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet:

Other sources of information

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