Nevanac

Patient Information Leaflet: Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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 and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NEVANAC is for use in adults

• to prevent and relieve pain and inflammation of the eye following cataract surgery
• to reduce the risk of macular edema (swelling at the back of the eye) following cataract surgery 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 nasal inflammation after 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 conditions (e.g. an eye infection) or if you are using other ophthalmic medicines (especially topical steroids).
• if you have diabetes.
• if you suffer from rheumatoid arthritis.
• if you have undergone repeated eye surgeries within a short period of time.

Avoid exposure to sunlight during treatment with NEVANAC.
Wearing contact lenses is not recommended after cataract surgery. Your doctor will advise you when it is safe to resume wearing contact lenses (see also “NEVANAC contains benzalkonium chloride”).

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

Other medicines and NEVANAC
Inform your doctor or pharmacist if you are currently 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 used to treat glaucoma.
Also inform your doctor if you are taking medications that reduce blood clotting (e.g. warfarin) or other NSAIDs. These may increase the risk of bleeding.

Pregnancy and breastfeeding
If you are pregnant, think you may become pregnant, consult your doctor before using NEVANAC. Women of childbearing potential are advised to use effective contraception during treatment with NEVANAC. The use of NEVANAC is not recommended during pregnancy.
Do not use NEVANAC unless specifically instructed by your doctor.
During breastfeeding, NEVANAC may pass into breast milk. However, effects on breastfed infants are not expected. NEVANAC may be used during breastfeeding.
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
Do not drive or operate machinery until your vision has cleared. Your vision may become temporarily blurred immediately after using NEVANAC.

NEVANAC contains benzalkonium chloride
This medicine contains 0.25 mg of benzalkonium chloride per 5 ml, equivalent to 0.05 mg/ml.
The preservative in NEVANAC, benzalkonium chloride, may be absorbed by soft contact lenses and may cause a change in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (damage to the transparent outer layer of the eye). If you experience unusual sensations in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use NEVANAC

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Use NEVANAC only in your eyes. Do not swallow or inject it.
Recommended dose
One drop into the affected eye(s), three times daily – in the morning, at midday, and in the evening. Use the medicine every day at the same times.
When to take it and for how long
Start one day before cataract surgery and continue on the day of the surgery. After that, continue using it for as long as your doctor instructs. This may be up to 3 weeks (to prevent and relieve eye pain and inflammation) or 60 days (to prevent the development of macular edema) after surgery.
How to use NEVANAC
Wash your hands before starting.

1 2

• Shake the bottle well before use.
• Unscrew the bottle cap.
• After removing the cap, if the safety seal has loosened, remove it before using the product.
• Hold the bottle between your thumb and other fingers, with the tip pointing downwards.
• Tilt your head backwards.
• Pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye, into which you will place the eye drop (Figure 1).
• Bring the tip of the bottle close to your eye. If helpful, do this in front of a mirror.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip: the eye drop could become contaminated.
• Gently press the bottom of the bottle to release one drop of NEVANAC at a time (Figure 2).
• Do not squeeze the bottle: it is specifically designed so that gentle pressure on the bottom is sufficient (Figure 2).

If you need to apply the eye drop in both eyes, repeat these steps for the other eye.
Close the bottle carefully immediately after use.
If a drop does not enter the eye, try again.
If you are using another eye drop at the same time, wait at least five minutes between using NEVANAC and applying the other eye drop.
If you use more NEVANAC than you should
Contact your doctor for specific instructions. Do not use the eye drops again until the time for your next scheduled 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, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for a forgotten dose. Do not use more than one drop per affected eye three times a day.
If you stop using NEVANAC
Do not stop treatment with NEVANAC without first consulting your doctor. You can usually continue using the eye drops unless side effects are severe. If you are concerned, speak to your doctor or pharmacist.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
There may be an increased risk of adverse corneal reactions (problems affecting the eye surface) in the case of:

• complicated eye surgeries
• repeated eye surgeries within a short period of time
• certain disorders of the eye surface, such as inflammation or dry eye
• certain systemic diseases, such as diabetes or rheumatoid arthritis

Contact your doctor immediately if your eyes become red or if you experience pain during use of the eye drops. This could be due to inflammation of the eye surface, with or without loss or damage to cells, or inflammation of the coloured 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 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 disorders: inflammation of the eye surface with or without cell damage, sensation of foreign body in the eye, crusting or drooping of the eyelid

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

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

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects helps provide more information on the safety of this medicine.

5. 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 bottle and the carton after
EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Discard the bottle 4 weeks after first opening in order to prevent infections. Write the date of
bottle opening on the label of the bottle and carton in the designated space.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What NEVANAC contains

• The active substance is nepafenac. One ml of suspension contains 1 mg of nepafenac.
• The other components are benzalkonium chloride (see section 2), carbomer, edetate disodium, mannitol, purified water, sodium chloride and tiloxapole. Small amounts of sodium hydroxide and/or hydrochloric acid are added to maintain normal acidity levels (pH values).

Description of the appearance of NEVANAC and contents of the pack
NEVANAC is a liquid (a suspension ranging from pale yellow to light orange) supplied in a
package containing 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
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 Nuremberg
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00
Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872
Deutschland Nederland
Cranach Pharma GmbH Novartis Pharma B.V.
Tel: +49 40 3803837-10 Tel: +31 88 04 52 111
Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00
Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570
España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50
Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: + 421 2 5542 5439
Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200
Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu

Package leaflet: information for the user

NEVANAC 3 mg/ml eye drops, suspension

nepafenac
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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 and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NEVANAC is for use in adults:

• To prevent and relieve eye pain and inflammation following cataract surgery.
• To reduce the risk of macular edema (swelling at the back of the eye) following cataract surgery in diabetic patients.

2. What you should 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 nasal inflammation after 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 ophthalmic medicines (especially topical steroids).
• if you have diabetes.
• if you suffer from rheumatoid arthritis.
• if you have undergone repeated eye surgeries within a short period of time.

Avoid exposure to sunlight during treatment with NEVANAC.
Wearing contact lenses is not recommended after cataract surgery. Your doctor will advise you when you can resume using contact lenses (see also “NEVANAC contains benzalkonium chloride”).
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as safety and efficacy in this population have not been established.
Other medicines and NEVANAC
Inform your doctor or pharmacist if you are currently 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 inform your doctor if you are taking medications that reduce blood clotting (e.g., warfarin) or other NSAIDs. These may increase the risk of bleeding.
Pregnancy and breastfeeding
If you are pregnant, think you might become pregnant, consult your doctor before using NEVANAC. Women of childbearing potential are advised to use effective contraception during treatment with NEVANAC. Use of NEVANAC is not recommended during pregnancy. Do not use NEVANAC unless specifically instructed by your doctor.
During breastfeeding, NEVANAC may pass into breast milk. However, effects on breastfed infants are not expected. NEVANAC may be used during breastfeeding.
If you are pregnant, think you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Do not drive or operate machinery until your vision is clear again. Your vision may become temporarily blurred immediately after using NEVANAC.
NEVANAC contains benzalkonium chloride
This medicine contains 0.15 mg of benzalkonium chloride per 3 ml, equivalent to 0.05 mg/ml.
The preservative in NEVANAC, benzalkonium chloride, may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience unusual sensations, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use NEVANAC

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use NEVANAC only in your eyes. Do not swallow or inject.
The recommended dose is
One drop into the affected eye(s), once daily. Use the medicine every day
at the same time.
When to take it and for how long
Start one day before cataract surgery and continue on the day of the surgery. After that,
use it for as long as your doctor tells you. This may be up to 3 weeks
(to prevent and relieve eye pain and inflammation) or 60 days (to prevent the
development of macular edema and improve vision) after surgery.
How to use NEVANAC
Wash your hands before starting.

1 2

• Shake well before use.
• With the bottle still closed, turn it upside down and shake it once downward before each use.
• Unscrew the bottle cap.
• After removing the cap, if there is a safety ring that has loosened, remove it before using the product.
• Hold the bottle between your thumb and fingers, with the tip pointing downward.
• Tilt your head backward.
• Pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye, into which you will place the eye drop (Figure 1).
• Bring the tip of the bottle close to the eye. You may find it helpful to do this in front of a mirror.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip: the eye drop could become contaminated.
• Gently squeeze the sides of the bottle until one drop falls into the eye (Figure 2).

If you need to apply the eye drops to both eyes, repeat these steps for the other eye.
It is not necessary to close and shake the bottle between applications to each eye.
Close the bottle carefully immediately after use.
If a drop does not enter the eye, try again.
If you are using another eye drop at the same time, wait at least five minutes between using NEVANAC and applying the other eye drop.
If you use more NEVANAC than you should
Contact your doctor for detailed instructions. Do not use the eye drops again until the time for your next scheduled dose.
If you forget to use NEVANAC
Apply a single dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for a missed dose. Do not use more than one drop per affected eye.
If you stop using NEVANAC
Do not stop treatment with NEVANAC without first consulting your doctor. You can usually continue using the eye drops unless side effects are severe.
If you have any questions about how to use 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.
There may be an increased risk of adverse corneal reactions (problems affecting the ocular surface) in the case of:

• complicated eye surgeries
• repeated eye surgeries within a short period of time
• certain disorders of the ocular surface, such as inflammation or dry eye
• certain systemic diseases, such as diabetes or rheumatoid arthritis.

Contact your doctor immediately if your eyes become red or if you experience pain during use of the eye drops. This could be due to inflammation of the ocular surface with or without loss or damage to cells, or inflammation of the coloured 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 disorders: inflammation of the ocular surface with or without cell damage, sensation of a foreign body in the eye, crusting or drooping of the eyelid.

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

• Eye disorders: iritis, eye pain, eye discomfort, dry eye, eyelid swelling, eye irritation, eye pruritus, eye discharge, allergic conjunctivitis (eye allergy), increased lacrimation, deposits on the ocular surface, fluid or swelling at the back of the eye, eye redness.
• General disorders: dizziness, headache, allergic symptoms (eyelid swelling due to allergy), nausea, inflammation, redness and itching of the skin.

Not known (frequency cannot be estimated from the available data)

• Eye disorders: damage to the ocular surface such as thinning or perforation, impaired healing of the eye, scarring of the ocular surface, clouding, reduced vision, eye swelling, blurred vision.
• General disorders: vomiting, increased blood pressure.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 refers to the last day of that month.
Do not store above 25°C. Keep the bottle in the outer packaging to protect the medicine from light.
Dispose of the bottle 4 weeks after first opening, in order to prevent infections. Write the date of opening of the bottle on the carton label in the space provided.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What NEVANAC contains

• 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, sodium carmellose, sodium 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 values).

Description of the appearance of NEVANAC and contents of the pack
NEVANAC ophthalmic suspension is a liquid (a suspension ranging from pale yellow to dark orange)
supplied in a plastic bottle with a screw cap. Each bottle may be contained within a
wrapper.
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
Roonstrasse 25
90429 Nuremberg
Germany
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:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Cranach Pharma GmbH Novartis Pharma B.V.
Tel: +49 40 3803837-10 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: + 421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu