Flarex 1mg/ml, eye drops, suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUOROMETHOLONE ACETATE

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

S01BA07

INN (International Name):

FLUOROMETHOLONE ACETATE 1 mg/ml

Pharmaceutical form:

EYE DROPS, SUSPENSION

Composition:

FLUOROMETHOLONE ACETATE 1 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2005-09-07

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLAREX®, 1MG/ML, EYE DROPS, SUSPENSION
FLUOROMETHOLONE ACETATE
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 Flarex eye drops is and what it is used for
2. What you need to know before you use Flarex eye drops
3. How to use Flarex eye drops
4. Possible side effects
5. How to store Flarex eye drops
6. Contents of the pack and other information
1.
WHAT FLAREX EYE DROPS IS AND WHAT IT IS USED FOR
Flarex eye drops is a corticosteroid for the treatment of eye
inflammations.
Flarex eye drops is indicated for the treatment of inflammations of
the conjunctiva, cornea and the
anterior segment of the eye, if these inflammations react to
corticosteroids and are not caused by germs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FLAREX EYE DROPS
DO NOT USE FLAREX EYE EROPS
-
If you are allergic to fluorometholone or any of the other ingredients
of this medicine
-
If you think you have:
-
An untreated bacterial infection of the eye.
-
Herpes simplex keratitis, Smallpox, Chickenpox/Herpes Zoster, or any
other viral infection
of the eye
-
Fungal diseases of the eye
-
Tuberculosis of the eye
WARNINGS AND PRECAUTIONS
Not for injection.
Only use Flarex eye drops for dropping in your eye(s).
Talk to your doctor or pharmacist before using Flarex eye drops
-
If you have glaucoma. Your doctor will determine if the benefits of
Flarex eye drops treatment
are greater than the risk of aggravating your condition. Your eye
pressure should be monitored weekly
and your glauco

Summary of Product characteristics

Page
1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FLAREX, 1 mg/ml, eye drops, suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluorometholone acetate 1.0 mg/ml. For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Eye drops, suspension.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of steroid-responsive, non-infectious inflammations of the
palpebral and bulbar
conjunctiva, cornea and anterior segment of the eye.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Shake well before using.
Adults:
1 to 2 drops in the conjunctival sac 4 times daily. During the initial
48 hours the
dosage may be safely increased
to 2 drops every 2 hours.
If there is no
improvement after 2 weeks, consult the physician. Care should be taken
not to
discontinue therapy prematurely.
Children:
Flarex eye drops suspension is usually not recommended for pediatric
use
since its safety and effectiveness have not been established.
Elderly:
There are no special precautions to be followed.
If used in patients with glaucoma, treatment should be limited to 2
weeks, unless longer treatment
is justified (see 4.3 Contraindications and 4.4 Special warnings and
special precautions for use).
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
•
Acute, untreated bacterial infections
7
•
Herpes simplex keratitis
•
Vaccinia, varicella, and other viral infections of cornea or
conjunctiva
•
Fungal diseases of ocular structures
•
Mycobacterial ocular infections
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Not for injection.
The extensive
and/or prolonged
use of ophthalmic
corticosteroids
increases
the risk of ocular
complications and could cause systemic side effects. If the
inflammatory condition does not respond
within a reasonable period during the course of the therapy, other
forms of therapy should be instituted
to reduce these risks.
Topical application of corticosteroids may be accompanied by a
decrease in the urinary secretion of
cortisol as well as a de