Yellox 0.9 mg/ml eye drops solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Yellox 0,9 mg/ml eye drops solution

Bromfenac

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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Yellox is and what it is used for

2. What you need to know before you use Yellox

3. How to use Yellox

4. Possible side effects

5. How to store Yellox

6. Contents of the pack and other information

1. What Yellox is and what it is 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 ocular inflammation after cataract surgery in adults.

2. What you need to know before using Yellox

Do not use Yellox

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

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 adverse effects.

• if you have bleeding disorders (e.g., haemophilia) or have had them in the past, or if you 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 disorders).

• if you have diabetes.

• if you have rheumatoid arthritis.

• if you have undergone multiple eye surgeries within a short period of time.

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

Children and adolescents

Yellox must not be used in children or adolescents.

Using Yellox with other medicines

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 fetus.

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

Driving and using machines

This eye drop may cause temporary blurred vision. If you experience blurred vision after instillation, do not drive or operate machinery until your vision clears.

Yellox contains benzalkonium chloride

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

Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, particularly 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 Yellox

Follow exactly the instructions for using this medicine as given by your doctor.

If you have any doubts, consult your doctor or pharmacist.

Dosage

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

Method of administration

Yellox is administered by ophthalmic route.

• Wash your hands before using the eye drops.

• Position yourself comfortably and steadily.

• Unscrew the cap of the bottle.

• Hold the bottle, pointing downwards, between your fingers.

• Tilt your head backwards.

• Pull down the lower eyelid with one finger.

• Bring the tip of the bottle close to the eye.

• Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip.

• Gently squeeze the bottle so that one drop of Yellox falls into the eye.

• Close the bottle cap tightly immediately after use.

• Keep the bottle tightly closed when not in use.

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

Duration of treatment

Continue using the drops for the first 2 weeks after surgery. Do not use Yellox for longer than 2 weeks.

If you use more Yellox than you should

Rinse the eye with lukewarm water. Do not instill any more drops until it is time for your next scheduled dose.

If Yellox is accidentally swallowed, drink a glass of water or other liquid 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 use a double dose to make up for a forgotten dose.

If you stop using Yellox

Do not stop treatment with Yellox without discussing it with your doctor.

In rare cases, worsening of the inflammatory response has been observed after discontinuation of Yellox, for example, swelling of the retina following cataract surgery.

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

4. Possible adverse effects

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

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

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

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

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

Rare adverse effects (may affect 1 in 1,000 people)

Damage to the eye surface, eye redness, asthma.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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 included in Appendix V. By reporting adverse 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 stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

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 properly dispose of unused medicines and their packaging. This helps 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 components are: boric acid, borax, anhydrous sodium sulfite (E221), benzalkonium chloride (see section 2), tiloxapol, povidone (K30), disodium edetate, water for injections, sodium hydroxide to maintain normal acidity levels (pH levels).

Nature of the product and contents of the container

Yellox is a clear yellow liquid (solution) supplied in a box containing one 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 patient information leaflet has been last revised in

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