Yellox
Authorised
This medicine is authorised for use in the European Union
bromfenac
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Yellox. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Yellox.
For practical information about using Yellox, patients should read the package leaflet or contact their doctor or pharmacist.
Yellox is a medicine used in adults to treat inflammation in the eye that can occur after an operation to remove a cataract (clouding of the lens).
Yellox contains the active substance bromfenac.
Yellox is available as an eye drop solution and the recommended dose is one drop into the affected eye(s) twice a day. Treatment begins the day after the cataract operation and continues for two weeks.
If more than one eye medicine is being used, they should be given at least five minutes apart.
The medicine can only be obtained with a prescription. For more information see the package leaflet.
The active substance in Yellox, bromfenac, is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process. By reducing the production of prostaglandins in the eye, Yellox can reduce the inflammation caused by eye surgery.
Yellox was found to be more effective than placebo (a dummy treatment) at relieving inflammation in the eye following cataract surgery in two main studies involving a total of 527 patients undergoing cataract surgery. In both studies, the main measure of effectiveness was the number of patients with no sign of inflammation after two weeks. In one study, 66% of patients treated with Yellox (104 out of 158) had no signs of inflammation after two weeks compared with 48% of patients receiving placebo (35 out of 73). In the second study, the figures were: 63% (124 out of 198) for patients treated with Yellox and 40% (39 out of 98) for those treated with placebo.
The most common or most important side effects seen with Yellox are abnormal sensation in eye (0.5%), mild or moderate erosion of the cornea (the transparent layer in front of the eye) (0.4%), eye pruritus (itching) (0.4%), eye pain (0.3%) and eye redness (0.3%). For the full list of all side effects reported with Yellox, see the package leaflet.
Yellox must not be used in people who are hypersensitive (allergic) to bromfenac, to any of the other ingredients or to other NSAIDs. It must not be used in patients who get asthma attacks, urticaria (itchy rash) or acute rhinitis (stuffy and runny nose) from taking acetylsalicylic acid (aspirin) or other NSAIDs.
The European Medicines Agency decided that Yellox’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yellox have been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Yellox on 18 May 2011.
For more information about treatment with Yellox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: T/0031
04/02/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Yellox
- Active substance
- bromfenac sodium sesquihydrate
- International non-proprietary name (INN) or common name
- bromfenac
- Therapeutic area (MeSH)
- Pain, Postoperative
- Ophthalmologic Surgical Procedures
- Anatomical therapeutic chemical (ATC) code
- S01BC11
Pharmacotherapeutic group
OphthalmologicalsTherapeutic indication
Treatment of postoperative ocular inflammation following cataract extraction in adults.
Topics
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