Yellox 0.9 mg/ml eye drops, solution

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 causing inflammation.
Therefore, Yellox is used to reduce eye inflammation following cataract surgery in adults.

Do not use Yellox

• if you are allergic (hypersensitive) to bromfenac or to any of the other ingredients of Yellox (see section ?Further information? at the end of this leaflet).
• if you have experienced asthma, skin allergy or intense inflammation in your nose when using other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, diclofenac.

Take special care with Yellox

• if you are using topical steroids (e.g. cortisone), as this may cause unwanted side effects.
• if you have bleeding problems (e.g. haemophilia) or have had them in the past, or you are taking other medicines which may prolong bleeding time.
• if you have eye problems (e.g. dry eye syndrome, corneal problems).
• if you have diabetes.
• if you have rheumatoid arthritis.
• if you had repeated eye surgery within a short period of time.

Children and adolescents

Yellox should not be used in children and adolescents.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, talk to your doctor before you use Yellox.
Yellox should not be used during the last three months of pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Your vision may be blurred for a short time after using Yellox. If you experience blurred vision upon using Yellox, do not drive or use machines until your vision is clear.

Important information about some of the ingredients of Yellox

Yellox contains sodium sulphite which may cause allergic reactions.
Yellox contains benzalkonium chloride, a preservative which may cause eye irritation. Do not use Yellox while wearing contact lenses, since benzalkonium chloride is known to discolour them. Additionally, wearing contact lenses is not recommended after cataract surgery. Therefore, do not wear contact lenses whilst using Yellox.

Always use Yellox exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dose and duration of treatment

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) 2 times daily.
Start taking Yellox the next day after your cataract surgery. Continue the drops through the first 2 weeks after your surgery. Do not use Yellox longer than 2°weeks.

Administration

• Wash your hands before using the eye drops.
• Put yourself in a comfortable and stable position.
• Twist off the bottle cap.
• Hold the bottle, pointing down, between your thumb and fingers.
• Tilt your head back.
• Pull down your lower eyelid with a clean finger.
• Bring the bottle tip close to the eye.
• Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
• Gently squeeze the bottle to release one drop of Yellox.
• Close the bottle cap firmly immediately after use.
• Keep the bottle tightly closed when not in use.

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

If you use more Yellox than you should

Rinse out your eye with warm water. Do not put in any more drops until it is time for your next regular dose. If Yellox is accidentally ingested, fluids (e.g. a glass of water) should be taken to dilute the medicine.

If you forget to use Yellox

Use a single dose as soon as you remember. If it is almost time for the next dose, leave out the missed dose. Continue with the next regularly scheduled dose. Do not use a double dose to make up for a forgotten dose.

If you stop using Yellox

Do not stop using Yellox without speaking to your doctor.

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

Like all medicines, Yellox can cause side effects, although not everybody gets them. If you experience decreased or blurred vision the week after the end of treatment, you should contact your doctor immediately.

The frequency of possible side effects listed below is defined using the following convention:

Very common Common Uncommon Rare Very rare Not known Affects more than 1 user out of 10 Affects 1 to 10 users in 100 Affects 1 to 10 users in 1,000 Affects 1 to 10 users in 10,000 Affects less than 1 user in 10,000 Frequency cannot be estimated from the available data

If you notice any of the following side effects while using the drops, contact your doctor immediately:

Uncommon side effects (Affects 1 to 10 users in 1,000)
Foreign body sensation in the eye, redness and inflammation of the eye, damage and inflammation of the surface of the eye, eye discharge, itching, irritation or pain of the eye, swelling or bleeding of the eyelid, impaired vision due to inflammation, floaters or moving spots before the eyes or diminishing vision that can indicate bleeding or damage of the back of the eye (retina), ocular discomfort, sensitivity to light, reduced or blurred vision, swelling of the face, cough, nosebleeding or runny nose.

Rare side effects (Affects 1 to 10 users in 10,000)
Damage of the eye surface, redness of the eye, asthma.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Yellox after the expiry date which is stated on the bottle and outer carton after ?EXP?. The expiry date refers to the last day of that month.

Do not store above 25°C.

Discard the bottle 4 weeks after first opening to prevent infection even if there is solution remaining. Write the date of opening on the carton label 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. These measures will help to protect the environment.

What Yellox contains

• The active substance is bromfenac. One ml of solution contains 0.9°mg bromfenac (as sodium sesquihydrate). One drop contains approximately 33 micrograms bromfenac.
• The other ingredients are: boric acid, borax, sodium sulphite anhydrous (E221), benzalkonium chloride, tyloxapol, povidone, disodium edetate, water for injection, sodium hydroxide (to keep acidity levels normal).

What Yellox looks like and contents of the pack

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

Marketing Authorisation Holder and Manufacturer
Croma-Pharma GmbH
Industriezeile 6
A-2100 Leobendorf
Austria
office@croma.at

Manufacturer
Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BELUNL Bausch Lomb Pharma nvsa, Belgium TélTel 32 03 280 82 60 CY Kypropharm Ltd. 357 22 43 46 99

BG Chauvin Ankerpharm Te. 359 2 952 57 09 LV SIROWA RIGA AS Tel 371 7098252

CZSK Chauvin Ankerpharm GmbH, Czech Republic Tel 420 2 84001071 LT UAB Sirowa Vilnius Tel 370 5 2 394150

HU Chauvin Ankerpharm Tel. 36 23 500-330 DKIEISNOFISEUK Bausch Lomb U.K., Ltd. UK 44 01748 828864 Republic of Ireland 08 1871 9318 local freephone or 44 01748 828849 Nordics 46 8616 9585

DE Dr. Gerhard Mann Chem.- Pharm Fabrik GmbH Tel 49 030 330930 MT Laboratoire Chauvin Tél 33 04 67 12 34 71

EE Sirowa Tallinn AS Tel 372 7407686 AT Croma-Pharma GmbH Tel 43 02262 684680

GR Kite Hellas Ltd 30 21 02014306 PL Croma-Pharma Polska SP.z o.o. Tel. 48 22 853 02 34

ES Croma-Pharma Espana SL Tel 34 93 634 26 90 PT Bausch Lomb, S.A. Sucursal Portugal Tel 351 21 424 15 10

FR CROMA S.A.S.U. Tél 33 01 45 15 60 60 RO Croma-Pharma SA Tel 40 264 58 58 66

IT Bausch Lomb-IOM S.p.A. Tel 39 039 20731 SI Biokorp d.o.o. Tel 386 1 430 31 18

This leaflet was last approved in