Yellox 900microgramsml eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bromfenac sodium sesquihydrate

Available from:

Bausch & Lomb UK Ltd

ATC code:

S01BC11

INN (International Name):

Bromfenac sodium sesquihydrate

Dosage:

900microgram/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11080200; GTIN: 5027519008865

Patient Information leaflet

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
YELLOX 0,9 MG/ML
/BROMFENAC/ DRP
5ML (BOTTLE)
Kolor nadruku Colours
Black
Kraj
Country (ISO)
UK/IE
Nr wykrojnika
Spec No
12036
Opracowane przez
Designed by
5536
Kod Wytwórcy
Manufacturer code
49829PB744/8-UK
Nr korekty
Proof No
2
Data
Date
13.02.2018
Kod farmaceutyczny
Pharmacode
1212
Kod wersji
Valeant version code
P1UKIE05
Inny kod
Other code
-
Rozmiar czcionki
Font size
MINIMUM 9 PT
Wymiar ulotki
PIL size
120 X 360 MM
Krój czcionki
Font used
MYRIAD PRO SEMIBOLD
Myriad Pro Regular
Gramatura papieru
Paper weight
- G/M
2
Komentarze Comments (Reason for the change)
CORRECTION UK HA CONTACT DETAILS VIA APPENDIX V V14 UPDATED 4 JULY
2017
PMR_ICN-18-0167-A PACKING SITE: DMP BERLIN
FOR TECHNICAL DATA (COMPONENTS CODES) MINIMUM FONT SIZE: 7 PT
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
YELLOX®
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
4. Possible side effects
5. How to store YELLOX®
6. Contents of the pack
and other information
2. What you need to know before you use
YELLOX®
3. How to use YELLOX®
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

Summary of Product characteristics

OBJECT 1
YELLOX 0.9 MG/ML, EYE DROPS SOLUTION
Summary of Product Characteristics Updated 30-Aug-2016 | Bausch & Lomb
U.K Limited
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
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 aci