FML Liquifilm 0.1% w/v Sterile Eye Drops Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluorometholone

Available from:

Allergan Pharmaceuticals Ireland

ATC code:

S01BA; S01BA07

INN (International Name):

Fluorometholone

Dosage:

0.1 percent weight/volume

Pharmaceutical form:

Eye drops, suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Corticosteroids, plain; fluorometholone

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FML LIQUIFILM 0.1% W/V STERILE EYE DROPS SUSPENSION
(Fluorometholone)
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 further questions, please ask your doctor, pharmacist or
nurse.
-
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 of the side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What FML Liquifilm is and what it is used for
2. What you need to know before you use FML Liquifilm
3. How to use FML Liquifilm
4. Possible side effects
5. How to store FML Liquifilm
6. Contents of the pack and other information
1. WHAT FML LIQUIFILM IS AND WHAT IT IS USED FOR
FML Liquifilm is an eye drop containing the active substance
Fluorometholone which is a steroid that
is used to treat inflammation of the eye.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FML LIQUIFILM
DO NOT USE FML:
- if you are allergic to fluorometholone, or any of the other
ingredients of this medicine (listed in section
6).
- if you have a bacterial, active viral, or fungal infection of the
eye.
WARNINGS AND PRECAUTIONS
You should not use FML Liquifilm for more than one week unless your
doctor or eye specialist advises
it.
Prolonged use may cause the pressure inside your eye (intraocular
pressure) to increase which could
lead to glaucoma, rarely damage to the optic nerve, lack of clearness
of vision, cataracts, delay in
wound healing, or the development of an eye infection. The pressure in
your eye will be regularly
measured.
Contact your doctor if you experience blurred vision or other visual
disturbances.
If you have or have been previously treated for herpes simplex, use
FML only under close supervision
of your doctor.
CHILDREN
The safety an

Summary of Product characteristics

Health Products Regulatory Authority
22 September 2020
CRN009W0S
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FML Liquifilm 0.1% w/v Sterile Eye Drops Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre contains 1 mg Fluorometholone (0.1% w/v).
Excipients with known effect:
0.046 mg Benzalkonium chloride per mL
1.91 mg of Phosphates per mL
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, suspension
A white, microfine suspension
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FML Liquifilm is indicated for corticosteroid responsive inflammation
of the palpebral and bulbar conjunctiva, cornea, and
anterior segment of the globe.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
The safety and efficacy in children aged 2 years or less has not been
established.
No data are available.
_Elderly population_
No overall differences in safety or effectiveness have been observed
between elderly and younger patients.
Method of administration:
FML Liquifilm is for topical ophthalmic use only. Shake FML Liquifilm
suspension well before use.
Topically as drops into the conjunctival sac.
1-2 drops instilled into the conjunctival sac 2-4 times daily. During
the first 24 to 48 hours of treatment, the dose may be safely
increased to 2 drops at one hour intervals.
The treatment should not be withdrawn too early.
In chronic conditions, withdrawal of treatment should be carried out
by gradually decreasing the frequency of applications (see
section 4.4).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Health Products Regulatory Authority
22 September 2020
CRN009W0S
Page 2 of 5
FML Liquifilm is contraindicated in active viral diseases of the
cornea and conjunctiva, including epithelial herpes simplex
keratitis (dendritic keratitis), vaccinia, varicella, as well as
mycobacterial and untreated bacterial infection of the eye and fungal
diseases of ocular structure