Yellox
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
15-09-2022
Svojstava lijeka
(SPC)
15-09-2022
Izvješće o ocjeni javnog
(PAR)
17-11-2017
Aktivni sastojci:
bromfenac sodium sesquihydrate
Dostupno od:
Bausch + Lomb Ireland Limited
ATC koda:
S01BC11
INN (International ime):
bromfenac
Terapijska grupa:
Ophthalmologicals
Područje terapije:
Pain, Postoperative; Ophthalmologic Surgical Procedures
Terapijske indikacije:
Treatment of postoperative ocular inflammation following cataract extraction in adults.
Proizvod sažetak:
Revision: 11
Status autorizacije:
Authorised
Datum autorizacije:
2011-05-18
Uputa o lijeku
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
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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
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