YELLOX 0.9 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Yellox 0.9 mg/ml eye drops, solution

Bromfenac

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Yellox and what is it used for

1. What you need to know before you use Yellox
2. How to use Yellox
3. Possible side effects
4. Storage of Yellox
5. Contents of the pack and other information

1. What is Yellox and what is it used for

Yellox contains bromfenac and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking certain substances involved in inflammation.

Yellox is used to reduce eye inflammation after cataract surgery in adults.

2. What you need to know before you use Yellox

Do not use Yellox

• if you are allergic to bromfenac or any of the other ingredients of this medicine (listed in section 6).
• if you have experienced asthma, skin allergy, or severe nasal inflammation when using other NSAIDs. Examples of NSAIDs include acetylsalicylic acid, ibuprofen, ketoprofen, diclofenac.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Yellox

• if you are using topical steroids (e.g., cortisone), as this may cause unwanted side effects.
• if you have bleeding problems (e.g., hemophilia) or have had them in the past, or are taking other medicines that may prolong bleeding time (e.g., warfarin, clopidogrel, acetylsalicylic acid).

• if you have eye problems (e.g., dry eye syndrome, corneal problems).

• if you have diabetes.

• if you have rheumatoid arthritis.

• if you have had several eye surgeries in a short period of time.

It is not recommended to wear contact lenses after cataract surgery. Therefore, do not use contact lenses while using Yellox.

Children and adolescents

Yellox must not be used in children and adolescents.

Using Yellox with other medicines

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

Pregnancy, breastfeeding, and fertility

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

Yellox must not be used during the last three months of pregnancy. Your doctor may prescribe this medicine during pregnancy if the expected benefit to the mother outweighs the possible risk to the baby.

Yellox may be prescribed during breastfeeding and has no significant effect on fertility.

Driving and using machines

Your vision may be blurred temporarily when using this eye drop. If you experience blurred vision after instillation, do not drive or use machines until your vision clears.

Yellox contains benzalkonium chloride

This medicine contains 0.00185 mg of benzalkonium chloride per drop, which is equivalent to 0.05 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of the 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 eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use Yellox

Follow the instructions for administration of this medicine exactly as told by your doctor.

Consult your doctor or pharmacist if you have any questions.

Dose

The recommended dose is one drop of Yellox in the affected eye(s) twice a day (morning and evening). Do not use more than one drop in the affected eye(s) 2 times a day. Start using this eye drop the day after your cataract surgery.

Method of administration

Yellox is administered via the ocular route.

• Wash your hands before using the eye drop.

• Place yourself in a comfortable and stable position.
• Remove the cap from the bottle.
• Hold the bottle, pointing downwards, between your fingers.
• Tilt your head back.
• Pull down the lower eyelid with one finger.
• Bring the tip of the bottle close to the eye.
• Do not touch the eye, eyelid, or surrounding areas with the dropper.
• Gently press the bottle to release one drop of Yellox.
• Tighten the cap of the bottle immediately after use.
• Keep the bottle tightly closed when not in use.

If you use other eye drops, wait at least five minutes between using Yellox and the other eye drops.

Duration of treatment

Continue with the drops for the first 2 weeks after surgery. Do not use Yellox for more than 2 weeks.

If you use more Yellox than you should

Rinse your eye with lukewarm water. Do not put in more drops until it is time for your next usual dose.

If Yellox is accidentally ingested, drink a glass of water or other liquids to dilute the medicine.

If you forget to use Yellox

Instill one drop as soon as you remember. If it is almost time for your next dose, skip the missed dose. Continue with your next scheduled dose. Do not take a double dose to make up for the missed one.

If you stop using Yellox

Do not stop using Yellox without talking to your doctor.

In rare cases, after stopping Yellox, a worsening of the inflammatory response has been observed, for example, in the form of retinal swelling due to cataract surgery.

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

4. Possible side effects

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

If you experience loss of vision or blurred vision the week after finishing treatment, contact your doctor immediately.

If you notice any of the following side effects while using the eye drop, consult your doctor immediately:

Uncommon side effects (may affect up to 1 in 100 people)

Feeling of a foreign body in the eye, redness and eye inflammation, damage and inflammation of the eye surface, eye discharge, itching, irritation, or eye pain, swelling or bleeding of the eyelid, vision deterioration due to inflammation, "floaters" or moving spots before the eyes, or vision deterioration that may indicate bleeding or injury to the back of the eye (retina), eye discomfort, sensitivity to light, reduced or blurred vision, facial inflammation, cough, nosebleed, or runny nose.

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

Damage to the eye surface, eye redness, asthma.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, 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 Yellox

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 carton after "EXP". The expiry date is the last day of the month shown.

Do not store above 25°C.

Discard the bottle 4 weeks after first opening to avoid infections, even if there is solution left.

Write the date of opening on the label of the outer packaging in the space provided.

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

Composition of Yellox

• The active substance is bromfenac. 1 ml of solution contains 0.9 mg of bromfenac (as sodium sesquihydrate). One drop contains approximately 33 micrograms of bromfenac.
• The other ingredients are: boric acid, borax, sodium sulfite anhydrous (E221), benzalkonium chloride (see section 2), tyloxapol, povidone (K30), disodium edetate, water for injections, sodium hydroxide to adjust pH levels.

Appearance and packaging of the product

Yellox is a clear yellow liquid (solution) supplied in a carton containing a 5 ml plastic bottle with a screw cap.

Marketing authorisation holder

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer

Dr. Gerhard Mann

Chem.-pharm. Fabrik GmbH

Brunsbütteler Damm 165/173

13581 Berlin

Germany

This leaflet was last revised in

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