Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
bromfenac sodium sesquihydrate
Bausch + Lomb Ireland Limited
S01BC11
bromfenac
Ophthalmologicals
Pain, Postoperative; Ophthalmologic Surgical Procedures
Treatment of postoperative ocular inflammation following cataract extraction in adults.
Revision: 11
Authorised
2011-05-18
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 diabe Läs hela dokumentet
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 inhibit Läs hela dokumentet