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Yellox (bromfenac sodium sesquihydrate) – Package leaflet - S01BC11

Updated on site: 11-Oct-2017

Medication nameYellox
ATC CodeS01BC11
Substancebromfenac sodium sesquihydrate
ManufacturerPharmaSwiss Ceska Republika s.r.o

Package leaflet: Information for the user

Yellox 0.9 mg/ml eye drops, solution

Bromfenac

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

-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 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.

What is in this leaflet:

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 causing inflammation.

Yellox is used to reduce eye inflammation following 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 to any of the other ingredients of this medicine (listed in section 6).

-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.

Warning and precautions

Talk to your doctor or pharmacist before using this medicine

-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 (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 had repeated eye surgery within a short period of time.

Wearing contact lenses is not recommended after cataract surgery. Therefore, do not wear contact lenses whilst using Yellox.

Children and adolescents

Yellox should not be used in children and adolescents.

Other medicines and Yellox

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

Pregnancy , breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you use Yellox.

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

Yellox may be prescribed to breast-feeding woman and have no important influence on fertility.

Driving and using machines

Your vision may be blurred for a short time after using this eye drops. If you experience blurred vision upon instillation, do not drive or use machines until your vision is clear.

Yellox contains sodium sulphite and benzalkonium chloride

-Sodium sulphite may cause allergic reactions or asthma attacks, which may sometimes be severe and life-threatening.

-Benzalkonium chloride is a preservative which may cause eye irritation or eye surface problems. Do not use Yellox while wearing contact lenses, since benzalkonium chloride is known to discolour them.

3.How to use Yellox

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dose

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 using the drops the next day after your cataract surgery.

Method of administration

Yellox is for ocular use.

-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.

Duration of treatment

Continue the drops through the first 2 weeks after your surgery. Do not use Yellox longer than 2weeks.

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 swallowed, a glass of water or other fluid should be taken to water down 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.

In rare cases upon withdrawal of Yellox, a flare-up of the inflammatory response, e.g. in the form of retina swelling, due to the cataract operation has been observed.

If you have any further questions on 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 decreased or blurred vision the week after the end of treatment, contact your doctor immediately.

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

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

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

Damage of the eye surface, redness of the eye, asthma.

Reporting of side effects

If you get any side effects, talk to 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 listed in Appendix V.

By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Yellow

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 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

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 (see section 2), tyloxapol, povidone (K30), 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

PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c

17000 Praha 7

Czech Republic czech.info@valeant.com

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:

BE/LU/NL

CY

Bausch & Lomb Pharma nv/sa, Belgium

Kypropharm Ltd.

Tel: 00 31 (0) 20 20 61 682

Τηλ: + 357 22 43 46 99

BG

LV

PharmaSwiss EOOD

UAB „PharmaSwiss“

Teл.: + 359 2 89 52 110

Tel: + 371 67502185

CZ

LT

PharmaSwiss Česká republika s.r.o.

UAB „PharmaSwiss“

Tel: + 420 234 719 600

Tel. +370 5 2790 762

IE /UK

HU

Bausch & Lomb U.K., Ltd.

Valeant Pharma Magyarország Kft.

Tel: +44 (0) 1748 828864

Tel: +36 1 345 5900

DE

MT

Dr. Gerhard Mann Chem.- Pharm Fabrik GmbH

Laboratoire Chauvin, France

Tel: + 49 (0)30 33093 0

Tél: + 33 (0)4 67 12 30 30

EE

AT

PharmaSwiss Eesti OÜ

Dr. Gerhard Mann Chem.- Pharm Fabrik GmbH

Tel: + 372 6827403

Tel: + 49 (0)30 33093 0

GR

PL

Pharmaswiss Hellas A.E.

Valeant Pharma Poland sp. z o. o.

Τηλ: +30 210 8108 460

Tel.: +48 17 865 51 00

ES

PT

Bausch & Lomb, S.A.

Bausch & Lomb, S.A. (Sucursal Portugal)

Tel: + 34 91 657 63 36

Tel: + 351 21 424 15 10

FR

RO

Laboratoire Chauvin SAS

Valeant Pharma S.R.L.

Tél: + 33 (0)4 67 12 30 30

Tel: +40 374 102 600

IT

SI

Bausch & Lomb-IOM S.p.A.

PharmaSwiss d.o.o.

Tel: + 39 (0)2 27407300

Tel: + 386 1 2364 700

HR

SK

PharmaSwiss d.o.o.

Valeant Slovakia s.r.o.

Tel: +385 1 6311 833

Tel: + 421 3233 4900

 

DK/NO/FI/SE/IS

 

Bausch & Lomb Nordic AB

 

+46 8 616 95 00

This leaflet was last revised in

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

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