Patient leaflet - FML LIQUIFILM OPHTHALMIC 1 MG / ML EYE DROPS SUSPENSION
5. how to store fml
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated after “EXP” on the carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze.
After opening do not use this bottle for more than 28 days. To help you remember, write down the date you opened it in the space provided on the carton.
Keep the container tightly closed to prevent contamination.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other informationwhat fml containsthe active substance is fluorometholone 1 mg/ml.
The other ingredients are polyvinyl alcohol, benzalkonium chloride, edetate disodium, sodium chloride, disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, polysorbate 80, sodium hydroxide (for pH adjustment), and purified water.
What FML looks like and contents of the pack
FML is a white suspension supplied in a plastic dropper bottle with a screw cap.
The bottle contains 5 ml or 10 ml of suspension. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Allergan Limited
Marlow International
The Parkway
Marlow
Bucks
SL7 1YL
UK
Manufacturer:
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland
This leaflet was last revised in June 2020.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).
Please be ready to give the following information: Fluorometholone 1 mg/ml reference number PL 00426/0028.
This is a service provided by the Royal National Institute of Blind People.
— ALLERGAN
© 2020 Allergan, Inc., Irvine CA 92612
® Marks owned by Allergan, Inc. 72073MD215M
^@ALLERGAN
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 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 or your pharmacist.
-
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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 FML is and what it is used for
-
2. What you need to know before you use FML
-
3. How to use FML
-
4. Possible side effects
-
5. How to store FML
-
6. Contents of the pack and other information
1. what fml is and what it is used for
FML is an eye drops. It contains a steroid which is used to treat inflammation of the eye.
2. what you need to know before you use fmldo not use fml: if you are allergic (hypersensitive) to fluorometholone or any of the other ingredients of this medicine (listed in section 6).
- if you have a bacterial, viral, or fungal infection of the eye.
3. How to use FML
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended 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.
Instructions for use
You must not use the bottle if the seal on the bottle neck is broken before you first use it.
Shake the bottle before use. Wash your hands before opening the bottle.
Use your eye drops in the following way:
1.
4.
1. Tilt your head back and look at the ceiling.
2. Gently pull down the lower eyelid until there is a small pocket.
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.
4. Possible side effects
Like all medicines, this medicine can cause 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
Common (may affect up to 1 in 10 people)
Increased pressure inside your eye
Not known (frequency cannot be estimated from the available data) 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
Eye discharge
Excessive dilatation of the pupil
Excessive tear production
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) Blurred vision
Affecting the body
Not known (frequency cannot be estimated from the available data: Rash, abnormal sense of taste, allergic reactions (hypersensitivity)
Other side effects reported with eye drops containing phosphates
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.
Reporting of side effects
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:. By reporting side effects you can help provide more information on the safety of this medicine.