NEVANAC 3mg/ml COLLIRIUM IN SUSPENSION

Introduction

Package Leaflet: Information for the User

NEVANAC 3 mg/ml eye drops, suspension

nepafenac

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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.

Contents of the Package Leaflet

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

1. What is NEVANAC and what is it used for

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:

To prevent and relieve eye pain and inflammation after cataract surgery in the eye.

To reduce the risk of macular edema (inflammation in the back of the eye) after cataract surgery in the eye in diabetic patients.

2. What you need to know before you 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 allergy, or severe 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 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 medicines (especially eye steroids)
• if you have diabetes
• if you have rheumatoid arthritis
• if you have had several eye surgeries in a short time.

Avoid exposure to sunlight during treatment with NEVANAC.

It is not recommended to wear contact lenses after cataract surgery. Your doctor will tell you when you can start wearing contact lenses again. NEVANAC contains benzalkonium chloride

Children and Adolescents

Do not use this medicine in children and adolescents under 18 years of age since the safety and efficacy in this population have not been established.

Other Medicines and NEVANAC

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

NEVANAC may 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 using medicines that reduce blood clotting (warfarin) or other NSAIDs. These medicines may increase the risk of bleeding.

Pregnancy and Breastfeeding

If you are pregnant or might become pregnant, consult your doctor before using NEVANAC. Women who may become pregnant are advised to use effective contraceptive methods during treatment with NEVANAC. The use of NEVANAC is not recommended during pregnancy. Do not use NEVANAC unless clearly indicated by your doctor.

If you are breastfeeding, NEVANAC may pass into breast milk. However, no effects on the breastfed child are expected. You can use NEVANAC during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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 medicine contains 0.15 mg of benzalkonium chloride in each 3 ml equivalent to 0.05 mg/ml.

NEVANAC contains a preservative, benzalkonium chloride, which may be absorbed by soft contact lenses and may alter the color of contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before putting them back. Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases. Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to Use NEVANAC

Follow exactly the instructions of administration of this medicine 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(s), once a day. Use it at the same time each 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 indicates, which may be up to 3 weeks (to prevent and relieve eye pain and inflammation) or 60 days (to prevent the formation of macular edema and improve vision) after your surgery.

How to Use

Wash your hands before starting.

• Shake well before use.
• Hold the bottle with the cap facing downwards and shake it once before each use.
• Remove the cap from the bottle.
• After removing the cap, remove the security seal ring if present and loose before using this medicine.
• Hold the bottle, with the cap facing downwards, between your fingers.
• Tilt your head back.
• Gently pull down your lower eyelid to form a pouch in which the drop should fall (figure 1).
• Bring the tip of the bottle close to your eye. You can help yourself with a mirror.
• Do not touch your eye, eyelid, or surrounding areas with the dropper because the drops could become contaminated.
• Gently squeeze the sides of the bottle until one drop falls into your eye (figure 2).

If you are applying drops in both eyes, repeat the above steps for the other eye. You do not need to close and shake the bottle between administrations of 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 your next dose.

If You Forget to Use NEVANAC

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

If You Stop Using NEVANAC

Do not stop using NEVANAC without consulting your doctor. You can usually continue using the eye drops unless the effects are severe.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• have had complicated eye surgery
• have had several eye surgeries in a short time
• have certain disorders of the eye surface, such as inflammation or dry eyes
• have certain diseases, such as diabetes or rheumatoid arthritis

Contact your doctor immediately if your eyes become red or if the pain increases while you are using the drops. This may be due to inflammation of the eye surface with or without loss 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 people.

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

Uncommon(may affect up to 1 in 100 people)

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

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

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

Frequency Not Known(frequency cannot be estimated from the available data)

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 bottle and carton after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C. Store the bottle in the outer carton to protect it from light.

To avoid infections, discard the bottle 4 weeks after first opening. Write the date of opening on the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

• The active substance is nepafenac. One ml of suspension contains 3 mg of nepafenac.
• The other ingredients are boric acid, propylene glycol, carbomer, sodium chloride, guar powder, sodium carmellose, disodium edetate, benzalkonium chloride (see section 2), and purified water. Small amounts of sodium hydroxide and/or hydrochloric acid are added to maintain normal acidity levels (pH levels).

Appearance of the Product and Contents of the Pack

NEVANAC eye drops, suspension (eye drops) is a liquid (a suspension of pale yellow to dark orange) presented in a plastic bottle with a screw cap. The bottle may be in a bag.

Each pack contains one 3 ml bottle.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

Belgium

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

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