FML Liquifilm 0.1% ophthalmic suspension

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Fluorometholone

Fáanlegur frá:

AbbVie Ltd

ATC númer:

S01BA07

INN (Alþjóðlegt nafn):

Fluorometholone

Skammtar:

1mg/1ml

Lyfjaform:

Eye drops

Stjórnsýsluleið:

Ocular

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 11040100; GTIN: 5016007070705 5016007070804

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
FML
® LIQUIFILM
® OPHTHALMIC 1 MG/ML EYE DROPS SUSPENSION
Fluorometholone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What FML is and what it is used for
2. Before you use FML
3. How to use FML
4. Possible side effects
5. How to store FML
6. Further information
1.
WHAT FML IS AND WHAT IT IS USED FOR
FML is an eye drop. It contains a steroid which is used to treat
inflammation of the eye.
2.
BEFORE YOU USE FML
DO NOT USE FML

if you are allergic (hypersensitive) to fluorometholone, benzalkonium
chloride, or any of
the other ingredients of FML.

if you have a bacterial, viral, or fungal infection of the eye.
TAKE SPECIAL CARE WITH FML
You should not use FML 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, rare 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.
If you have or have been previously treated for herpes simplex, use
FML only under close
supervision of your doctor.
The use of the bottle by more than one person may spread infection.
Contact your doctor if you experience blurred vision or other visual
disturbances.
USING OTHER MEDICINES
Please tell your doctor if you are taking or have recently taken any
other medicines, including
medicines obtained without a prescription.
Some medicines may increase the effects of FML and your doctor may
w

Vara einkenni

OBJECT 1
FML
Summary of Product Characteristics Updated 17-Nov-2017 | Allergan Ltd
1. Name of the medicinal product
FML
®
Liquifilm
®
Ophthalmic 1 mg/ml eye drops, suspension
2. Qualitative and quantitative composition
One millilitre contains 1 mg Fluorometholone
For a 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
For corticosteroid responsive inflammation of the palpebral and bulbar
conjunctiva, cornea and anterior
segment of the globe.
4.2 Posology and method of administration
FML is for topical ophthalmic use only, applied as drops into the
conjuctival sac. Shake FML well before
use.
Instil 1 – 2 drops 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.
_Paediatric population _
The safety and efficacy in children aged 2 years or less has not been
established.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
FML is contraindicated in most 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 structures, and any
undiagnosed 'red eye' as this may
indicate a viral infection.
4.4 Special warnings and precautions for use
Eye drops containing corticosteroids should not be used for longer
than a week except under an eye
specialist's careful surveillance combined with regular measurement of
intraocular pressure.
Prolonged use of corticosteroids may result in elevated intraocular
pressure (IOP) with possible
development of glaucoma and infrequent damage to the optic nerve,
defects in visual acuity