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FML LIQUIFILM OPHTHALMIC SUSPENSION

Active substance(s): FLUOROMETHOLONE

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S365 LEAFLET FML 20151207

PACKAGE LEAFLET: INFORMATION FOR THE USER

Important information about some of the ingredients of FML

Your medicine is known as FML Liquifilm Ophthalmic Suspension
but will be referred to as FML throughout the following leaflet.

FML contains benzalkonium chloride as a preservative, which is
known to discolour soft contact lenses and can cause eye irritation.
If you wear soft contact lenses you must remove them before using
FML eye drops and wait at least 15 minutes before putting your
lenses back in.

Read all of this leaflet carefully before you start using this
medicine.

Ask your doctor or pharmacist for advice before taking any
medicine.

FML LIQUIFILM OPHTHALMIC SUSPENSION
(Fluorometholone)



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.

3. HOW TO USE FML
Always use FML exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
The usual dose is 1 or 2 drops of FML in each eye that needs
treatment 2 to 4 times a day, or more frequently if your doctor
advises it. During the first 24 - 48 hours of treatment your doctor
may advise you to apply 2 drops at one hour intervals.
Treatment should not be withdrawn too early.

In this leaflet:

Instructions for use

1. What FML is and what it is used for

You must not use the bottle if the seal on the bottle neck is broken
before you first use it.

2. Before you use FML
4. Possible side effects

Shake the bottle before use. Wash your hands before opening the
bottle.

5. How to store FML

Use your eye drops in the following way:

3. How to use 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.

1. Tilt your head back and look at the ceiling.
2. Gently pull down the lower eyelid until there is a small pocket.

2. BEFORE YOU USE FML

3. Turn the bottle upside down and gently squeeze it to release 1
or 2 drops into the eye.

Do not use FML

4. Let go of the lower lid, and close your eye for 30 seconds.



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.

5. Repeat steps 2 to 4 for the other eye, if it also needs treatment.
If a drop misses your eye, try again.
To keep the eye drops free from contamination and avoid eye
injury, do not let the tip of the bottle touch your eye or anything else.
Put the cap back on and close the bottle tightly straight after use.
Wipe off any excess liquid from your cheek with a clean tissue.
If you use more FML than you should

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 use more drops of FML than you should, it is unlikely to
cause you any harm. If you have placed too many drops in your
eye(s), wash your eyes with clean water. Put your next dose in at
the usual time.

If you have or have been previously treated for herpes simplex, use
FML only under close supervision of your doctor.

If anyone drinks FML by accident, it is unlikely to cause any harm.
The affected person should drink fluids to dilute.

The use of the bottle by more than one person may spread
infection.

If you forget to use FML

If you drink FML by accident

Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, even those obtained without a
prescription.

If you forget a dose, use FML as soon as you remember, unless it is
almost time for your next dose. Then use your next dose at the
usual time. Do not take a double dose to make up for a forgotten
dose.
If you stop using FML

If you are using other eye drops, leave at least 5 minutes before
putting in FML.

To work properly FML should be used as advised by your doctor or
pharmacist.

Children

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Using other medicines

The safety and effectiveness in children aged 2 years or less have
not been shown.
Pregnancy and breast feeding
Tell your doctor before you start using FML if you are pregnant or
planning to become pregnant or if you are breastfeeding. Your
doctor will decide if you should use FML during pregnancy or whilst
breastfeeding. Normally it is not recommended for use.
Driving and using machines
FML can cause temporary blurred vision. Should this occur, wait for
the blurring to clear before driving or operating machinery or taking
part in any activity where this could put yourself or others at risk.

4. POSSIBLE SIDE EFFECTS
Like all medicines, FML can have side effects, although not
everybody gets them. The following side effects are known to occur
but their frequency can vary, as shown.
If you experience swallowing or breathing difficulties, swelling of
your lips, face, throat or tongue contact your doctor or go to the
hospital immediately as this could be a sign of a serious allergic
reaction. The frequency of an allergic reaction is not known.

Affecting the eye

5. HOW TO STORE FML

Frequency - Common (affecting up to 1 in 10 patients):



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Increased pressure inside your eye



Do not store above 25°C. Do not freeze

Frequency not known:



Do not use after the expiry date printed on the carton label or
blister strip.



Discard 28 days after first opening.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Cataract (a loss of transparency of the lens of the eye with partial or
complete loss of vision)
Eye irritation
Eye inflammation
Redness of the eye
Itching of the eye
Eye pain
A feeling that something is in your eye
Difficulty in seeing clearly
Swelling of the eyelid or eye

6. FURTHER INFORMATION

Eye discharge

What FML contains

Excessive dilatation of the pupil

FML contains 0.1% w/v of fluorometholone.

Excessive tear production

FML also contain the following inactive ingredients: benzalkonium
chloride, sodium chloride, sodium hydroxide (to adjust pH),
polysorbate 80, polyvinyl alcohol, disodium edetate, sodium
phosphate monobasic, sodium phosphate dibasic and purified
water.

Ulcer(s) on the surface of the eye
Small breaks in the surface of the eye
Visual field defects
Secondary infections (including bacterial, fungal, and viral
infections)

What FML looks like and contents of the pack

Affecting the body

Each bottle of FML contains 5 ml of the medicine.

Frequency not known:

Product Licence holder

Rash, abnormal sense of taste, allergic reactions (hypersensitivity)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Other side effects reported with eye drops containing
phosphates

FML is a white sterile eye drop suspension.

In very rare cases, some patients with severe damage to the clear
layer at the front of the eye (the cornea) have developed cloudy
patches on the cornea due to calcium build-up during treatment.

Manufacturer

Reporting of side effects

POM

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this
medicine.

These products are manufactured by Allergan Pharmaceuticals
Ireland Limited, Westport, Co Mayo, Ireland.
PL: 19488/0365

Leaflet revision date: 07 December 2015
FML is a registered trade mark of Allergan Inc, USA
S365 LEAFLET FML 20151207

S365 LEAFLET FLUOROMETHOLONE 20151207

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUOROMETHOLONE 0.1% EYE DROPS SUSPENSION
Your medicine is known as Fluorometholone 0.1% Eye drops
Suspension but will be referred to as Fluorometholone throughout
the following leaflet.
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:

Important information about some of the ingredients of
Fluorometholone
Fluorometholone contains benzalkonium chloride as a preservative,
which is known to discolour soft contact lenses and can cause eye
irritation. If you wear soft contact lenses you must remove them
before using Fluorometholone eye drops and wait at least 15
minutes before putting your lenses back in.
Ask your doctor or pharmacist for advice before taking any
medicine.
3. HOW TO USE FLUOROMETHOLONE
Always use Fluorometholone exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
The usual dose is 1 or 2 drops of Fluorometholone in each eye that
needs treatment 2 to 4 times a day, or more frequently if your
doctor advises it. During the first 24 - 48 hours of treatment your
doctor may advise you to apply 2 drops at one hour intervals.
Treatment should not be withdrawn too early.

1. What Fluorometholone is and what it is used for

Instructions for use

2. Before you use Fluorometholone

You must not use the bottle if the seal on the bottle neck is broken
before you first use it.

3. How to use Fluorometholone
4. Possible side effects
5. How to store Fluorometholone
6. Further information

Shake the bottle before use. Wash your hands before opening the
bottle.
Use your eye drops in the following way:

1. WHAT FLUOROMETHOLONE IS AND WHAT IT IS USED FOR
Fluorometholone is an eye drop. It contains a steroid which is used
to treat inflammation of the eye.

1. Tilt your head back and look at the ceiling.
2. Gently pull down the lower eyelid until there is a small pocket.

2. BEFORE YOU USE FLUOROMETHOLONE
Do not use Fluorometholone


if you are allergic (hypersensitive) to fluorometholone,
benzalkonium chloride, or any of the other ingredients of
Fluorometholone.

 if you have a bacterial, viral, or fungal infection of the eye.
Take special care with Fluorometholone
You should not use Fluorometholone 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.

3. Turn the bottle upside down and gently squeeze it to release 1
or 2 drops into the eye.
4. Let go of the lower lid, and close your eye for 30 seconds.
5. Repeat steps 2 to 4 for the other eye, if it also needs treatment.
If a drop misses your eye, try again.
To keep the eye drops free from contamination and avoid eye
injury, do not let the tip of the bottle touch your eye or anything else.
Put the cap back on and close the bottle tightly straight after use.
Wipe off any excess liquid from your cheek with a clean tissue.
If you use more Fluorometholone than you should
If you use more drops of FLUOROMETHOLONE than you should, it
is unlikely to cause you any harm. If you have placed too many
drops in your eye(s), wash your eyes with clean water. Put your
next dose in at the usual time.

If you have or have been previously treated for herpes simplex, use
Fluorometholone only under close supervision of your doctor.

If you drink Fluorometholone by accident

The use of the bottle by more than one person may spread
infection.
Using other medicines

If you forget to use Fluorometholone

Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, even those obtained without a
prescription.

If anyone drinks FLUOROMETHOLONE by accident, it is unlikely to
cause any harm. The affected person should drink fluids to dilute.
If you forget a dose, use Fluorometholone as soon as you
remember, unless it is almost time for your next dose. Then use
your next dose at the usual time. Do not take a double dose to
make up for a forgotten dose.

If you are using other eye drops, leave at least 5 minutes before
putting in Fluorometholone.
Children

If you stop using Fluorometholone

The safety and effectiveness in children aged 2 years or less have
not been shown.
Pregnancy and breast feeding

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Tell your doctor before you start using Fluorometholone if you are
pregnant or planning to become pregnant or if you are
breastfeeding. Your doctor will decide if you should use
Fluorometholone during pregnancy or whilst breastfeeding.
Normally it is not recommended for use.

4. POSSIBLE SIDE EFFECTS

Driving and using machines

If you experience swallowing or breathing difficulties, swelling of
your lips, face, throat or tongue contact your doctor or go to the
hospital immediately as this could be a sign of a serious allergic
reaction. The frequency of an allergic reaction is not known.

Fluorometholone can cause temporary blurred vision. Should this
occur, wait for the blurring to clear before driving or operating
machinery or taking part in any activity where this could put yourself
or others at risk.

To work properly Fluorometholone should be used as advised by
your doctor or pharmacist.

Like all medicines, Fluorometholone can have side effects, although
not everybody gets them. The following side effects are known to
occur but their frequency can vary, as shown.

Affecting the eye

5. HOW TO STORE FLUOROMETHOLONE

Frequency - Common (affecting up to 1 in 10 patients):



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Increased pressure inside your eye



Do not store above 25°C. Do not freeze

Frequency not known:



Do not use after the expiry date printed on the carton label or
blister strip.



Discard 28 days after first opening.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Cataract (a loss of transparency of the lens of the eye with partial or
complete loss of vision)
Eye irritation
Eye inflammation
Redness of the eye
Itching of the eye
Eye pain
A feeling that something is in your eye
Difficulty in seeing clearly
Swelling of the eyelid or eye

6. FURTHER INFORMATION

Eye discharge

What Fluorometholone contains

Excessive dilatation of the pupil

Fluorometholone contains 0.1% w/v of fluorometholone.

Excessive tear production

Fluorometholone also contain the following inactive ingredients:
benzalkonium chloride, sodium chloride, sodium hydroxide (to
adjust pH), polysorbate 80, polyvinyl alcohol, disodium edetate,
sodium phosphate monobasic, sodium phosphate dibasic and
purified water.

Ulcer(s) on the surface of the eye
Small breaks in the surface of the eye
Visual field defects
Secondary infections (including bacterial, fungal, and viral
infections)

What Fluorometholone looks like and contents of the pack

Affecting the body

Each bottle of Fluorometholone contains 5 ml of the medicine.

Frequency not known:

Product Licence holder

Rash, abnormal sense of taste, allergic reactions (hypersensitivity)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Other side effects reported with eye drops containing
phosphates

Fluorometholone is a white sterile eye drop suspension.

In very rare cases, some patients with severe damage to the clear
layer at the front of the eye (the cornea) have developed cloudy
patches on the cornea due to calcium build-up during treatment.

Manufacturer

Reporting of side effects

POM

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this
medicine.

These products are manufactured by Allergan Pharmaceuticals
Ireland Limited, Westport, Co Mayo, Ireland.
PL: 19488/0365

Leaflet revision date: 07 December 2015
S365 LEAFLET FLUOROMETHOLONE 20151207

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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