Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Fluorometholone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for FML® Liquifilm® Ophthalmic suspension is an eye drop and contains the active substance fluorometholone which is used to treat inflammation of the eye.
2.
What you need to know before you take it
e FML Do 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. Warnings and precautions Talk to your doctor, pharmacist or nurse before using FML. You should not use FML for more than one week unless your doctor, pharmacist, nurse 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, pharmacist or nurse. The use of the bottle by more than one person may spread infection. Contact your doctor, pharmacist or nurse if you experience blurred vision or other visual disturbances. Other medicines and FML Tell your doctor, pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of FML and your doctor, pharmacist or nurse may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). If you are using other eye drops, leave at least 5 minutes before putting in FML. Children The safety and effectiveness in children aged 2 years or less have not been shown. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. 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. FML contains Benzalkonium chloride This medicine contains 0.046 mg benzalkonium chloride in each 1 ml Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor, pharmacist or nurse. FML Contains Phosphates This medicine contains 1.91 mg phosphates in each 1 mL If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment. Ask your doctor, pharmacist or nurse for advice before taking any medicine. 3.
How to take it
FML Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse 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, pharmacist or nurse advise it. During the first 24 – 48 hours of treatment your doctor, pharmacist or nurse 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. 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. 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 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 drink FML by accident If anyone drinks FML by accident, it is unlikely to cause any harm. The affected person should drink fluids to dilute. If you forget to use FML 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 To work properly FML should be used as advised by your doctor, pharmacist or nurse. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 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, pharmacist or nurse 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 Drooping eyelid(s) 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
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. 5.
How to store it
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. Once opened discard this bottle after 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 information
What FML contains The 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: AbbVie Ltd. Maidenhead SL6 4UB UK Manufacturer: Allergan Pharmaceuticals Ireland Castlebar Road Westport County Mayo Ireland This leaflet was last revised in June 2023.
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 41042/0065. This is a service provided by the Royal National Institute of Blind People.
Frequently asked questions about FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension
How do I take FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension?
FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension comes as oral solution containing 1mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension?
The active substance in FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension is fluorometholone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: fluorometholone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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
Method of administration
FML is for topical ophthalmic use only, applied as drops into the conjuctival sac. Shake FML well before use.
Posology
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 listed in section 6.1.
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 and fields of vision, posterior subcapsular cataract formation, and delayed wound healing. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
Acute untreated infection of the eye may be masked or activity enhanced by the presence of steroid medication.
Use of intraocular steroids may prolong the course and may exacerbate the severity of many viral infections on the eye (including herpes simplex). Use of a corticosteroid medication in the treatment of the patients with a history of herpes simplex keratitis requires great caution. Frequent follow-ups including slit lamp microscopy is recommended.
To prevent eye injury or contamination, care should be taken to avoid touching the applicator tip to the eye or to any other surface. The use of the bottle by more than one person may spread infection.
FML contains benzalkonium chloride which is irritant to the eye and could cause discoloration of soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses before FML is used and wait for at least 15 minutes before reinsertion.
Concomitant ocular medication should be administered 5 minutes prior to the installation of FML.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of fluorometholone in pregnant women.
Studies in animals have shown reproductive toxicity.
FML is not recommended during pregnancy.
Breast-feeding
It is unknown whether fluorometholone/metabolites are excreted in human milk. FML should not be used during breast-feeding.
4.7. Effects on ability to drive and use machines
FML has no influence on the ability to drive or use machines. However, instillation of any eye drop could result in transient blurring of vision. If this occurs, the patient should wait for the blurring to subside before driving or operating machinery or taking part in any activity where this could put themselves or others at risk.
4.8. Undesirable effects
Class effects:
Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.
The following undesirable effects have been reported since FML was marketed.
Adverse reactions are categorized by frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data).
Table 1: Adverse reactions
System Organ Class
Very common
(≥1/10)
Common
(≥ 1/100 to < 1/10)
Uncommon
(≥ 1/1,000 to < 1/100)
Not Known (cannot be estimated from the available data)
Immune system disorders
Hypersensitivity
Eye disorders
Intraocular pressure increased
Eye irritation, conjunctival/ocular hyperaemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid oedema, eyelid ptosis, blurred vision*, eye discharge, eye pruritis, lacrimation increased, eye oedema/eye swelling, mydriasis, cataract (including subcapsular)*, ulcerative keratitis, ocular infection (including bacterial, fungal*, and viral* infections), visual field defect, punctate keratitis.
Gastrointestinal disorders
Dysgeusia
Skin and subcutaneous tissue disorders
Rash
*See section 4.4 for further information
Adverse reactions reported in phosphate containing eye drops
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Overdosage by the topical ophthalmic route will not ordinarily cause acute problems.
If accidental overdosage occurs in the eye, the eye should be flushed with water or normal saline. If accidentally ingested, the patient should drink fluids to dilute.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- FLUMETOL S 2 mg/ml prescriptionFLUOROMETHOLONUM · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- FluconFluorometholonum · eye / ear / nose
- FlarexFluorometholoni acetas · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.