Active ingredient
- bromfenac sodium sesquihydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/11/692/001 .
Yellox 0.9 mg/ml, Eye Drops Solution
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.
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
Warning and precautions
Talk to your doctor or pharmacist before using this medicine
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 benzalkonium chloride
This medicine contains 0.00185 mg benzalkonium chloride in each drop which is equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
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.
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:
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland
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
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
Manufacturer
This leaflet was last revised in October 2020
Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu
Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK
+44 (0)800 041 8721
Tel: +44 (0)208 781 2991 Fax: +44 (0)208 781 295