YELLOX 0.9 MG / ML EYE DROPS SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - YELLOX 0.9 MG / ML EYE DROPS SOLUTION

YELLOX®

PACKAGE LEAFLET: INFORMATION FOR THE USER

YELLOX® 0.9 mg/ml eye drops, solution

Bromfenac

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine.

– Keep this 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
– 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. See section 4.

In this leaflet:

1. What YELLOX® is and what it is used for
- 4. Possible side effects
- 5. How to store YELLOX®
- 6. Further information
2. Before you use YELLOX®
3. How to use YELLOX®

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 causing inflammation.

Therefore, YELLOX® is used to reduce eye inflammation following cataract surgery in adults.

2. before you use yellox®

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®.

3. how to use 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.

P1XXXXX XXXXX

4. possible side effects

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	Affects more than 1 user out of 10 Affects 1 to 10 users in 100
Uncommon	Affects 1 to 10 users in 1,000
Rare	Affects 1 to 10 users in 10,000
Very rare Not known	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.

Reporting of side effects

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.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website:

Ireland

HPRA Pharmacovigilance,

Earlsfort Terrace,

IRL – Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517.

Website: ;

E-mail:.

5. how to store yellox®

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.

6. FURTHER INFORMATION
– 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

Manufacturer

PharmaSwiss Ceska republika s.r.o. Dr. Gerhard Mann

Jankovcova 1569/2c Chem.-pharm. Fabrik GmbH

17000 Praha 7 Brunsbutteler Damm 165–173

Czech Republic 13581 Berlin

Germany

For any information about this medicine, please contact the local representative of the

Marketing Authorisation Holder:

BE/LU/NL

Bausch & Lomb Pharma nv/sa,

Belgium

Tel/Tel BELUX: + 32 (0)3 280 82 84

Tel NL: + 31 (0)20 20 61 682

Kypropharm Ltd.

TnX: + 357 22 43 46 99

PharmaSwiss EOOD

Ten.: + 359 2 89 52 110

SIA PharmaSwiss

Latvia

Tel: + 371 67502185

CZ/SK

PharmaSwiss

Ceska republika s.r.o.

Tel: + 420 234 719 600

UAB „PharmaSwiss“

Tel. +370 5 2790 762

IE/IS/UK

Bausch & Lomb U.K., Ltd.

Tel: +44 (0) 1748 828864

Valeant Pharma Magyarorszag Kft.

Tel: +36 1 345 5900

Dr. Gerhard Mann

Chem.- Pharm Fabrik GmbH

Tel: + 49 (0)30 33093 5055

Laboratoire Chauvin, France

Tel: + 33 (0)4 67 12 30 30

PharmaSwiss Eesti

Tel: + 372 6827403

Dr. Gerhard Mann

Chem.- Pharm Fabrik GmbH

Tel: + 49 (0)30 33093 5055

Pharmaswiss Hellas A.E.

TnX: +30 210 8108 460

Valeant sp. z o.o. sp. j.

Tel.: +48 17 865 51 00

Bausch & Lomb, S.A.

Tel: + 34 91 657 63 00

Bausch & Lomb, S.A.

(Sucursal Portugal)

Tel: + 351 21 424 15 10

Laboratoire Chauvin SAS

Tel: + 33 (0)4 67 12 30 30

PharmaSwiss Medicines S.R.L.

Tel: +40 374 102 600

Bausch & Lomb-IOM

S.p.A.

Tel: + 39 039 20731

PharmaSwiss d.o.o.

Tel: + 386 1 2364 700

PharmaSwiss d.o.o.

Tel: +385 1 6311 833

DK/NO/FI/SE

Bausch and Lomb Nordic AB

DK Tel: 80 88 82 68 NO Tel: 800 19 841

FI Tel: 0800 773 851 SE Tel: 020 088 3496

From Abroad Tel.: +46 8 616 95 85

This leaflet was last approved in

Detailed information on this medicine is available on the website of the European Medicines Agency:.