Nevanac 3 mg/ml eye drops in suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NEVANAC 3 mg/ml eye drops, suspension

nepafenac

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

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

1. What NEVANAC is and what it is 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 ocular pain and inflammation following cataract surgery in the eye.
• To reduce the risk of macular edema (swelling at the back of the eye) following cataract surgery in the eye in diabetic patients.

2. What you need to know before using NEVANAC

Do not use NEVANAC

• if you are allergic to nepafenac or to 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 previously experienced asthma, skin allergy, or severe inflammation of the nose when taking other NSAIDs. Examples of NSAIDs include: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, and diclofenac.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using NEVANAC:

• if you bruise easily or have a bleeding disorder or a history of bleeding problems
• if you have any other eye disorders (e.g., an eye infection) or if you are using other eye medications (especially ophthalmic steroids)
• if you have diabetes
• if you have rheumatoid arthritis
• if you have undergone multiple eye surgeries in a short period of time.

Avoid exposure to sunlight during treatment with NEVANAC.

The use of contact lenses after cataract surgery is not recommended. Your doctor will advise you when you can resume using contact lenses (see also “NEVANAC contains benzalkonium chloride”).

Children and adolescents

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

Other medicines and NEVANAC

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

NEVANAC may affect or be affected by other medicines you are using, including other eye drops used to treat glaucoma.

Also inform your doctor if you are using medicines that reduce blood clotting (e.g., warfarin) or other NSAIDs. These medicines may increase the risk of bleeding.

Pregnancy and breastfeeding

If you are pregnant or think you could become pregnant, consult your doctor before using NEVANAC. Women who could 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 clearly indicated by your doctor.

If you are breastfeeding, NEVANAC may pass into breast milk. However, effects on the breastfed infant are not expected. NEVANAC may be used during breastfeeding.

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

Driving and using machines

Do not drive or operate machinery until your vision is clear. Immediately after applying NEVANAC, you may experience temporary blurred vision.

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 can be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use NEVANAC

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Recommended dose

One drop into the affected eye(s) once daily. Use it at the same time each day.

When to use and for how long

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

How to use

Wash your hands before starting.

• Shake well before use.
• Hold the closed bottle upside down and tap it downward once before each use.
• Unscrew 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 upside down between your fingers.
• Tilt your head backward.
• Gently pull down the lower eyelid of your eye with one finger, creating a small pocket where the drop should fall (figure 1).
• Bring the tip of the bottle close to your eye. You may use a mirror to help.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip, as the drops could become contaminated.
• Gently squeeze the sides of the bottle until one drop falls into your eye (figure 2).

If applying drops to both eyes, repeat the steps above for the other eye. It is not necessary to close and shake the bottle between applications to both eyes. Immediately after use, tightly screw the cap back onto the bottle.

If a drop misses 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 additional drops until it is time for your next dose.

If you forget to use NEVANAC

Apply a single dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose; simply continue with your next scheduled dose. Do not use a double dose to make up for forgotten doses. Do not apply more than one drop into the affected eye(s).

If you stop using NEVANAC

Do not stop treatment with NEVANAC without consulting your doctor. Generally, you may continue using the eye drops unless side effects are severe.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• a complicated eye surgery
• multiple eye surgeries in a short time
• certain surface eye disorders, such as inflammation or dry eye
• certain diseases such as diabetes or rheumatoid arthritis

Contact your doctor immediately if your eyes become red or if 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 adverse effects have been observed in up to 1 in 100 people.

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

Uncommon (may affect up to 1 in 100 people)

• Eye effects: inflammation of the eye surface with or without cell damage or loss, sensation of foreign body in the eyes, crusting 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 eye, eyelid swelling, eye irritation, eye itching, eye discharge, allergic conjunctivitis (eye allergy), increased tearing, deposits on the eye surface, fluid accumulation or swelling at the back of the eye, eye redness.

• General adverse effects: dizziness, headache, allergic symptoms (allergic swelling of the eyelids), nausea, itching, skin redness, and inflammation.

Frequency not known (cannot be estimated from available data)

• Eye effects: damage to the eye surface such as thinning or perforation, delayed healing of the eye, corneal scarring, sensation of haze, reduced vision, eye swelling, blurred vision.

• General adverse effects: vomiting, increased blood pressure.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the bottle and the carton after EXP. The expiry date is the last day of the month indicated.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

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

Product appearance and contents of the container

NEVANAC eye drops (suspension) is a liquid (a pale yellow to dark orange suspension) supplied in a plastic bottle with a screw cap. The bottle may be contained within a pouch.

Each pack contains one 3 ml bottle.

Marketing Authorization 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

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review 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