Yellox

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
  



 

2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Yellox 0.9 mg/ml eye drops solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1 ml of solution contains 0.9 mg bromfenac (as sodium sesquihydrate).  
One drop contains approximately 33 micrograms bromfenac. 
 
Excipient(s) with known effect:  
Each ml of solution contains 50 micrograms of benzalkonium chloride. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Eye drops, solution. 
Clear yellow solution. 
pH: 8.1-8.5; osmolality: 270-330 mOsmol/kg 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Yellox is indicated in adults for the treatment of postoperative ocular inflammation following cataract 
extraction . 
 
4.2 Posology and method of administration 
 
Posology 
Use in adults, including the elderly 
The dose is one drop of Yellox in the affected eye(s) twice daily, beginning the next day after cataract 
surgery and continuing through the first 2 weeks of the postoperative period.  
 
The treatment should not exceed 2 weeks as safety data beyond this is not available. 
 
Hepatic and renal impairment 
Yellox has not been studied in patients with hepatic disease or renal impairment. 
 
Paediatric population 
The safety and efficacy of bromfenac in paediatric patients has not been established. No data are 
available. 
 
Method of administration 
For ocular use. 
 
If more than one topical ophtalmic medicinal product is being used, each one should be administered 
at least 5 minutes apart. 
 
To prevent contamination of the dropper-tip and solution, care must be taken not to touch the eyelids, 
surrounding areas or other surfaces with the dropper-tip of the bottle 
 
 
 



 

3 

4.3 Contraindications 
 
Hypersensitivity  to  bromfenac or  to any of the excipients listed in section 6.1, or to other non-
steroidal anti-inflammatory medicinal products (NSAIDs). 
Yellox is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are 
precipitated by acetylsalicylic acid or by other medicinal products with prostaglandin synthetase 
inhibiting activity. 
 
4.4 Special warnings and precautions for use 
 
All topical NSAIDs may slow or delay healing like topical corticosteroids. Concomitant use of 
NSAIDs and topical steroids may increase the potential for healing problems. 
 
Cross-sensitivity 
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and 
other NSAIDs. Therefore, treating individuals who have previously exhibited sensitivities to these 
medicinal products has to be avoided (see section 4.3). 
 
Susceptible persons 
In susceptible patients, continued use of topical NSAIDs, including bromfenac may result in epithelial 
breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events 
may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately 
discontinue use of topical NSAIDs and should be closely monitored for corneal health. Consequently 
in at risk patients concomitant use of ophthalmic corticosteroids with NSAIDs may lead to a higher 
risk of corneal adverse events. 
 
Postmarketing experience 
Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular 
surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus and ocular surface diseases 
e.g. dry eye syndrome, rheumatoid arthritis or repeat ocular surgeries within a short period of time 
may be at increased risk for corneal adverse reactions which may become sight threatening. Topical 
NSAIDs should be used with caution in these patients. 
 
There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues 
(including hyphaema) in conjunction with ocular surgery. Yellox should be used with caution in 
patients with known bleeding tendencies or who are receiving other medicinal products which may 
prolong bleeding time. 
 
It has been observed in rare cases that upon withdrawal of Yellox, a flare-up of the inflammatory 
response, e.g. in the form of macular oedema, due to the cataract operation may occur. 
 
Ocular infection 
An acute ocular infection may be masked by the topical use of anti-inflammatory medicinal products. 
 
Use of contact lenses 
In general, contact lens wear is not recommended during the postoperative period following cataract 
surgery. Therefore, patients should be advised not to wear contact lenses during treatment with Yellox. 
 
Excipients 
Since Yellox contains benzalkonium chloride, close monitoring is required with frequent or prolonged 
use.  
Benzalkonium chloride is known to discolour soft contact lenses. Contact with soft contact lenses 
must be avoided. 
Benzalkonium chloride has been reported to cause eye irritation, punctuate keratopathy and/or toxic 
ulcerative keratopathy.  
Yellox contains sodium sulphite which may cause allergic-type reactions including anaphylactic 
symptoms and life-threatening or less severe asthmatic episodes in susceptible patients. 



 

4 

 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. No interactions with antibiotic eye drops used in 
conjunction with surgery have been reported.  
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no adequate data from the use of bromfenac in pregnant women. Studies in animals have 
shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Since the 
systemic exposure in non-pregnant women is negligible after treatment with Yellox, the risk during 
pregnancy could be considered low.  
 
However, because of the known effects of prostaglandin biosynthesis-inhibiting medicinal products on 
the foetal cardiovascular system (closure of ductus arteriosus), the use of Yellox during third trimester 
pregnancy should be avoided. The use of Yellox is in general not recommended during pregnancy 
unless the benefit outweighs the potential risk. 
 
Breast-feeding 
It is unknown whether bromfenac or its metabolites are excreted in human milk. Animal studies have 
shown excretion of bromfenac in the milk of rats following very high oral doses (see section 5.3). No 
effects on the breastfed newborn/infant are anticipated since the systemic exposure of the 
breastfeeding woman to bromfenac is negligible. Yellox can be used during breast-feeding. 
 
Fertility 
No effects of bromfenac on the fertility were observed in animal studies. In addition the systemic 
exposure to bromfenac is negligible; for this reason no pregnancy testing or contraceptive measures 
are required. 
 
4.7 Effects on ability to drive and use machines 
 
Yellox has minor influence on the ability to drive and use machines. Transient blurring of vision may 
occur on instillation. If blurred vision occurs at instillation patients should be advised to refrain from 
driving or using machines until vision is clear. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
Based on clinical data available, a total of 3.4% of patients experienced one or more adverse reactions. 
The most common or most important reactions in the pooled studies were abnormal sensation in eye 
(0.5%), corneal erosion (mild or moderate) (0.4%), eye pruritus (0.4%), eye pain (0.3%) and eye 
redness (0.3%). Corneal adverse reactions were only observed in the Japanese population. Adverse 
reactions rarely led to withdrawal, with a total of 8 (0.8%) patients who prematurely discontinued 
treatment in a study due to an adverse reaction. These comprised 3 (0.3%) patients with mild corneal 
erosion, 2 (0.2%) patients with eyelid oedema and 1 (0.1%) patient each with abnormal sensation in 
eye, corneal oedema, or eye pruritus.  
 
Tabulated list of adverse reactions 
The following adverse reactions were classified according to the following convention: Very common 
(≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000); 
very rare (<1/10,000).  Within each frequency grouping, adverse reactions are presented in order of 
decreasing seriousness. 
 
The table below describes adverse reactions by system organ class and frequency. 
 
MedDRA system organ Frequency Adverse reactions 



 

5 

class 
Eye disorders Uncommon  Visual acuity reduced 

Haemorrhagic retinopathy 
Corneal epithelium defect** 
Corneal erosion (mild or moderate) 
Corneal epithelium disorder 
Corneal oedema 
Retinal exudates 
Eye pain 
Eyelid bleeding 
Vision blurred 
Photophobia  
Eyelid oedema 
Eye discharge 
Eye pruritus 
Eye irritation 
Eye redness 
Conjunctival hyperaemia 
Abnormal sensation in eye 
Ocular discomfort 

Rare Corneal perforation* 
Corneal ulcer* 
Corneal erosion, serious* 
Scleromalacia* 
Corneal infiltrates* 
Corneal disorder * 
Corneal scar* 

Respiratory, thoracic and 
mediastinal disorders 

Uncommon  Epistaxis 
Cough 
Nasal sinus drainage 

Rare Asthma* 
General disorders and 
administrative site 
conditions 

Uncommon  Face swelling 

*Serious reports from post-marketing experience of more than 20 million patients 
** Observed with four times daily dose  
 
Patients with evidence of corneal epithelial breakdown should be instructed to immediately 
discontinue use of Yellox and should be monitored closely for corneal health (see section 4.4). 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
No abnormal findings or adverse reactions of clinical concern were noted upon administration of two 
drops 2mg/ml solution four times a day for the period of up to 28 days. Accidental administration of 
more than one drop should not result in increased topical exposure as excessive volume would rinse 
out of the eye due to limited conjunctival sac capacity. 
 



 

6 

There is practically no risk of adverse effects due to accidental oral ingestion. Ingestion of the 5 ml 
bottle content corresponds to an oral dose of less than 5 mg bromfenac, which is 30 times lower than 
daily dose of bromfenac oral formulation formerly used.  
If Yellox is accidentally ingested, fluids should be taken to dilute the medicinal product. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Ophtalmologicals, Antiinflammatory agents, non-steroids, ATC code: 
S01BC11. 
 
Mechanism of action 
Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity 
which is thought to be due to its ability to block prostaglandin synthesis by inhibiting primarily 
cyclooxygenase 2 (COX-2). Cyclooxygenase 1 (COX-1) is only inhibited to a small extent.  
In vitro, bromfenac inhibited the synthesis of prostaglandins in the rabbit iris ciliary body. The IC50-
values were lower for Bromfenac (1.1 μM) than for indometacin (4.2 μM) and pranoprofen (11.9 μM) 
Bromfenac at concentrations of 0.02%, 0.05%, 0.1% and 0.2% inhibited almost all signs of ocular 
inflammation in an experimental uveitis model in rabbits. 
 
Clinical efficacy 
Two Phase II multicentre, randomised, double-masked, parallel group studies were conducted in 
Japan, and two Phase III multicentre, randomised (2:1), double-masked, parallel group, placebo-
controlled studies were conducted in the US to assess the clinical safety and efficacy of Yellox dosed 
twice daily in the treatment of post-operative inflammation in patients undergoing cataract surgery. In 
these studies, study substance was administered approximately 24 hours after cataract surgery and 
continued for up to 14 days. Treatment effect was evaluated up to 29 days. 
A significantly greater proportion of patients in the Yellox group 64.0% vs. 43.3% in the placebo 
group (p<0.0001) experienced complete clearance of ocular inflammation at study day 15. There was 
significantly less anterior chamber cells and flare within the first 2 weeks post-surgery (85.1% of 
patients with flare score of ≤1) vs. placebo (52%). The difference in the rate of inflammation clearance 
showed as early as day 3. 
In a large, well-controlled study that was conducted in Japan, Yellox was shown to be as effective as 
pranoprofen ophthalmic solution. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Yellox in all subsets of the paediatric population in postoperative ocular inflammation (see section 4.2 
for information on paediatric use) 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Bromfenac efficiently permeates the cornea of cataract patients: A single dose resulted in a mean peak 
aqueous humour concentrations of 79±68 ng/ml at 150-180 minutes after dosing. Concentrations were 
maintained for 12 hours in aqueous humour with measurable levels up to 24 hours in major ocular 
tissues including the retina. Following twice daily dosing with bromfenac eye drops plasma 
concentrations were not quantifiable. 
 
Distribution 
Bromfenac shows high binding to plasma proteins. In vitro, the 99.8% were bound to proteins in 
human plasma. 
No biological relevant melanin binding was observed in vitro. 



 

7 

Studies in rabbits using radio-labelled bromfenac have demonstrated that highest concentrations after 
topical administration are observed in the cornea followed by the conjunctiva and the aqueous 
humour. Only low concentrations were observed in the lens and vitreous. 
 
Biotransformation 
In vitro studies indicate that bromfenac is mainly metabolised by CYP2C9, which is absent in both 
iris-ciliary body and retina/choroid and the level of this enzyme in the cornea is less than 1% 
compared to the corresponding hepatic level. 
In orally treated humans unchanged parent compound is the major component in plasma. Several 
conjugated and unconjugated metabolites have been identified with the cyclic amide being the major 
urinary metabolite. 
 
Elimination 
After ocular administration the half-life of bromfenac in aqueous humour is 1.4 h indicating rapid 
elimination. 
After oral administration of 14C-bromfenac to healthy volunteers, urinary excretion was found to be 
the major route of radioactive excretions, accounting for approximately 82% while faecal excretion 
represented approximately 13% of the dose. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, 
pharmacology, ‘repeated-dose’ toxicity, genotoxicity and carcinogenic potential. However, 
0.9 mg/kg/day in rats at oral doses (900 times the recommended ophthalmic dose) caused embryo-
foetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated 
orally with 7.5 mg/kg/day (7500 times the recommended ophthalmic dose) caused increased post-
implantation loss (see section 4.6). 
 
Animal studies have shown excretion of bromfenac in breast milk when applied orally at doses of 
2.35 mg/kg which is 2350 times the recommended ophthalmic dose. However, following ocular 
administration plasma levels were not detectable (see section 5.2). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Boric acid 
Borax 
Sodium sulphite, anhydrous (E221) 
Tyloxapol 
Povidone (K30) 
Benzalkonium chloride 
Disodium edetate 
Water for injections 
Sodium hydroxide (for pH adjustment) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
After first opening: 4 weeks. 
 
 



 

8 

6.4 Special precautions for storage 
 
Do not store above 25°C. 
Patients should be instructed to keep the bottle tightly closed when not in use.  
 
6.5 Nature and contents of container 
 
5 ml solution in a polyethylene squeeze bottle with a dropper-tip and a polyethylene screw cap. 
Pack of 1 bottle. 
 
 
6.6 Special precautions for disposal  
 
No special requirements.  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Bausch Health Ireland Limited 
3013 Lake Drive 
Citywest Business Campus 
Dublin 24, D24PPT3 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/692/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 18.05.2011 
Date of latest renewal: 11.01.2016 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
 
 
 
 
 
 
 

 
 
 
 
 
 
 



 

9 

 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C.         OTHER CONDITIONS AND REQUIREMENTS OF THE 
             MARKETING AUTHORISATION 
 
 D.        CONDITIONS OR RESTRICTIONS WITH REGARD TO 
            THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
            PRODUCT  
 
 
 

 



 

10 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
 
Dr. Gerhard Mann 
Chem.-pharm. Fabrik GmbH 
Brunsbütteler Damm 165–173 
13581 Berlin 
Germany 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines web-
portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND  
 EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Risk Management Plan (RMP) 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any 
subsequent updates of the RMP.  
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 
being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached.  



 

11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 
  



 

12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



 

13 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR SINGLE BOTTLE 5 ML 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Yellox 0.9 mg/ml eye drops solution 
bromfenac  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 ml of solution contains 0.9 mg bromfenac (as sodium sesquihydrate).  
One drop contains approximately 33 micrograms bromfenac. 
 
 
3. LIST OF EXCIPIENTS 
 
Boric acid, borax, sodium sulphite anhydrous (E221) (see the package leaflet for further information), 
tyloxapol, povidone, disodium edetate, benzalkonium chloride (see the package leaflet for further 
information), water for injections, sodium hydroxide (for pH adjustment) 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
eye drops, solution 
1x5 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Ocular use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHTAND REACH   OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
Discard any unused contents 4 weeks after first opening. 
Opened:  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 



 

14 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bausch Health Ireland Limited 
3013 Lake Drive 
Citywest Business Campus 
Dublin 24, D24PPT3 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/11/692/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Yellox  
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 

15 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
BOTTLE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Yellox 0.9 mg/ ml eye drops, solution 
bromfenac  
Ocular use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
   
5 ml  
 
 
6. OTHER 
  



 

16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 

17 

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. 
 



 

18 

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.  
 



 

19 

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. 
 



 

20 

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  
Bausch Health 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 website of the European Medicines Agency 
http://www.ema.europa.eu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET