Consumer medicine information

FML Eye Drops

Fluorometholone

BRAND INFORMATION

Brand name

FML

Active ingredient

Fluorometholone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using FML Eye Drops.

What is in this leaflet

This leaflet answers some common questions about FML® eye drops, (including how to use the eye drops). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using FML® eye drops against the benefits they expect it will have for you.

If you have any concerns about using/taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What FML® eye drops are used for

FML® eye drops are used for the treatment of pain, swelling and redness of the eye (inflammation).

The active ingredient in FML® eye drops, fluorometholone, acts by inhibiting the inflammation caused by certain irritations in the eye.

FML® eye drops are only available with a doctor’s prescription from pharmacies.

Your doctor may have prescribed FML® eye drops for another reason. Ask your doctor if you have any questions about why FML® eye drops have been prescribed for you.

Before you use FML® eye drops

When you must not use it

Do not use FML® eye drops if:

  • you are suffering from certain medical conditions such as herpes simplex keratitis
  • you have an eye infection caused by fungi or viruses
  • you have an allergy to FML® eye drops or any of the ingredients listed at the end of this leaflet
  • you have tuberculosis of the eye
  • the seal around the cap is broken
  • the bottle/packaging shows signs of tampering
  • the product does not look quite right.
  • the expiry date on the bottle or carton has passed

If you use this medicine after the expiry date has passed, it may not work effectively.

Do not put the eye drops into your eye(s) while you are wearing soft contact lenses. The preservative in FML® eye drops (benzalkonium chloride) may be absorbed by and cause discolouration of soft contact lenses. You can put your soft contact lenses back into your eyes 15 minutes after you have used FML® eye drops.

The safety of FML® eye drops in children under 2 years of age is not known. Therefore these drops should not be used in very young children.

These eye drops are for topical use only.

If you are not sure whether you should start using FML® eye drops, talk to your doctor.

Before you start to use it.

Tell your doctor if

  1. you have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes.
  2. you have ever had herpes simplex keratitis or have glaucoma.
  3. you have recently had an eye infection.
  4. you are pregnant or have the intention of becoming pregnant. Safety of the use of topical steroids during pregnancy has not been established.
  5. you are breastfeeding or planning to start breastfeeding. It is not known whether your baby may absorb this medicine from breast milk and therefore there is a possibility of harm to the baby.

If you have not told your doctor about this, tell them before you use FML® eye drops.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

There are no known drug interactions with FML® eye drops.

How to use FML® eye drops

How much to use

Your doctor will tell you how many drops you need to use each day. Use FML® eye drops only as prescribed by your doctor.

The usual dosage of FML® eye drops is one to two drops in the affected eye(s) two to four times daily. During the first 24 to 48 hours, your doctor may advise to increase the dosage to 2 drops every hour.

Do not stop using FML® eye drops even if you feel well unless instructed by your doctor.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Use FML® eye drops every day, at about the same time each day, unless your doctor tells you otherwise. Using your eye drops at the same time each day will have the best effect on your condition. It will also help you remember when to use the eye drops.

If you are using more than one eye drop product, wait 5 minutes before using the second product.

If you are being changed from one eye drop to another, follow your doctor’s instructions carefully as to when to stop the old drops and when to start the new drops.

How to use it

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are wearing soft contact lenses, remove them before putting the drops in your eye.

To open a new bottle of FML® eye drops, first tear off the protective seal from the bottle.

The contents are sterile if the seal is intact.

The seal will break and you can pull it off and then throw it away.

  1. Wash your hands well with soap and water.
  2. Shake the bottle gently.
  3. Remove the cap.
  4. Hold the bottle upside down in one hand between your thumb and forefinger or index finger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
  6. Tilt your head back and look up.
  7. Put the tip of the bottle close to your lower eyelid. Do not let it touch your eye.
  8. Release one drop into the pouch or pocket formed between your eye and eyelid by gently squeezing the bottle.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. Ask your doctor for more specific instructions on this technique.
  11. Replace the cap, sealing it tightly.
  12. Wash your hands again with soap and water to remove any residue.

Wait 15 minutes before replacing your contact lenses.

Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops. Contaminated eye drops may give you an eye infection.

How long to use it

Continue using FML® eye drops for as long as your doctor prescribes.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use the drops as soon as you remember, and then go back to using/taking them as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not use double the amount to make up for the dose that you missed.

If you use too much (overdose)

If you accidentally put several drops in your eye(s), immediately flush your eye(s) with water.

If you think that you or anyone else may have swallowed any or all of the contents of a bottle of FML® eye drops, immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital. In New Zealand call the National Poisons Information Centre (telephone 0800 POISON or 0800 764 766).

Do this even if there are no signs of discomfort or poisoning.

While you are using FML® eye drops

Things you must do

If you develop an eye infection, receive an eye injury, or have eye surgery tell your doctor.

Your doctor may tell you to use a new container of FML® eye drops because of possible contamination of the old one, or may advise you to stop your treatment with FML® eye drops.

If you become pregnant while using FML® eye drops tell your doctor immediately.

If you wear soft contact lenses, remove them before using FML® eye drops. Leave your lenses out for at least 15 minutes after putting in the eye drops.

Tell your doctor if your condition gets worse or does not get better while using FML® eye drops.

Tell your doctor if you experience any blurred vision or any other disturbances in vision.

If you are about to start on any new medicine tell your doctor and pharmacist that you are using FML® eye drops.

Things you must not do

Do not give FML® eye drops to anyone else, even if they have the same condition as you.

Do not stop using FML® eye drops without first talking to your doctor.

Things to be careful of

Your vision may blur for a short time after you put in your FML® eye drops. If this happens you should wait until you can see well again before you drive or use machinery.

FML® eye drops are not expected to cause any problems with your ability to drive a car or operate machinery. However, as a general precaution be careful when driving or operating machinery until you know how FML® eye drops affect you.

Eye drops containing a corticosteroid should not be used for more than 10 days except under ophthalmic supervision with regular checks for increased pressure in the eye.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using FML® eye drops.

FML® eye drops help most people with inflammation of the eye, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.

Some side effects of FML® eye drops are:

  • fungal, bacterial or viral eye infections which may take longer to heal.
  • blurred vision (cataract)
  • in long term use, development of increased pressure in the eye.
  • thinning of the cornea or sclera
  • blurring of vision
  • swelling of the eye or surrounding areas
  • itching, redness, pain
  • redness; inflammation of the cornea
  • feeling of having something in the eye
  • dilation of the pupil
  • altered sense of taste
  • visual disturbance or decreased sharpness of vision
  • hypersensitivity
  • rash
  • discharge from the eye
  • delayed wound healing
  • droopy eyelids
  • calcium deposits in the cornea

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects and they worry you.

After using FML® eye drops

Storage

Keep your FML® eye drops in a cool place where the temperature stays below 25°C.

Store upright. Do not freeze the eye drops.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Do not carry the eye drops in the pockets of your clothes. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave the top/lid off the bottle for any length of time to avoid contaminating the eye drops.

Disposal

Write the date on the bottle when you open the eye drops and throw out any remaining solution after four weeks.

Eye drops contain a preservative which helps prevent germs growing in the solution for the first four weeks after opening the bottle. After this time there is a greater risk that the drops may become contaminated and cause an eye infection. A new bottle should be opened.

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining solution.

Product description

What it looks like

The eye drops come in a 5 mL sterile plastic bottle.

Ingredients

Active ingredient:
Fluorometholone

Preservative:
Benzalkonium chloride

Inactive ingredients:
Polyvinyl alcohol, disodium edetate, sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate heptahydrate, polysorbate 80, sodium hydroxide and purified water.

Manufacturer/Supplier

AbbVie Pty Ltd
241 O’Riordan Street
Mascot NSW 2020
AUSTRALIA
Ph: 1800 043 460

AbbVie Limited
6th Floor, 156-158 Victoria St
Wellington, 6011
NEW ZEALAND
PH: 0800 900 030

ARTG number:
AUST R 23212

Date of preparation:
August 2023

FML and its design are trademarks of Allergan, Inc., an AbbVie company.

© 2023 AbbVie. All rights reserved.

Published by MIMS October 2023

BRAND INFORMATION

Brand name

FML

Active ingredient

Fluorometholone

Schedule

S4

 

1 Name of Medicine

FML - fluorometholone 1 mg/mL eye drops.

2 Qualitative and Quantitative Composition

FML eye drops contain fluorometholone 1 mg/mL (0.1%).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A topical anti-inflammatory glucosteroid eye drop.

4 Clinical Particulars

4.1 Therapeutic Indications

For steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

4.2 Dose and Method of Administration

Bottle should be shaken before use.
1 to 2 drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be safely increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely.
In order to minimise systemic absorption of FML eye drops, apply pressure to the tear duct immediately following administration of the drug.

4.3 Contraindications

FML is contraindicated in patients with:
acute superficial (or epithelial) herpes simplex keratitis (dendritic keratitis);
fungal diseases of ocular structures;
vaccinia, varicella, mycobacterial infection of the eye and most other viral diseases of the cornea and conjunctiva;
tuberculosis of the eye;
hypersensitivity to the constituents of this medication.

4.4 Special Warnings and Precautions for Use

Steroid medication in the treatment of patients with a history of herpes simplex keratitis requires great caution. Frequent slit lamp microscopy is mandatory (see Section 4.3 Contraindications).
Eye drops containing a corticosteroid should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure.
Prolonged use may cause increased intraocular pressure in susceptible individuals, resulting in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision; posterior subcapsular cataract formation and delayed wound healing; or may aid in the establishment of secondary ocular infections from fungi or viruses liberated from ocular tissues. Steroids should be used with caution in the presence of glaucoma; intraocular pressure should be checked frequently.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
Acute purulent untreated infection of the eye may be masked or activity enhanced by the presence of steroid medication.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application, fungal invasion must be suspected in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate.
Intraocular pressure should be checked frequently.
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, consider evaluating for 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.

Information for patients.

To prevent eye injury or contamination, care should be taken to avoid touching the bottle tip to the eye or to any other surface. The use of the bottle by more than one person may spread infection. Keep the bottle tightly closed when not in use. Keep out of the reach of children.
The preservative in FML, benzalkonium chloride, may be absorbed by and cause discolouration of soft contact lenses. Patients wearing soft contact lenses should be instructed to remove contact lenses prior to administration of the solution and wait at least 15 minutes after instilling FML before reinserting soft contact lenses.

Use in the elderly.

No data available.

Paediatric use.

Safety and effectiveness have not been demonstrated in children under 2 years of age.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Although the systemic exposure is expected to be low with topical ophthalmic corticosteroid administration, co-treatment with CYP3A inhibitors may increase the risk of systemic corticosteroid-related side-effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
There are no adequate well-controlled studies in pregnant women. Fluorometholone has been shown to be teratogenic, fetotoxic and embryocidal in rabbits when given in doses approximating the human dose and above. Safety of the use of topical steroids during pregnancy has not been established. Fluorometholone was ocularly applied to both eyes of pregnant rabbits on days 6 to 18 of gestation. A significant dose-related increase in foetal abnormalities and in foetal loss was observed.
FML should be used with caution during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
 It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

4.7 Effects on Ability to Drive and Use Machines

As with any ocular medication, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

Immune system disorders.

Hypersensitivity.

Nervous system disorders.

Dysgeusia.

Eye disorders.

Elevation of intraocular pressure (IOP) with possible development of glaucoma, and optic nerve damage, loss of visual acuity or defects in fields of vision, eye irritation, conjunctival/ocular hyperaemia, eye pain, visual disturbances, foreign body sensation, eyelid oedema, eyelid ptosis, blurred vision, eye discharge, eye pruritus, lacrimation increased, eye oedema/eye swelling, mydriasis, cataract (including posterior subcapsular cataract formation), ulcerative keratitis, ocular infection (including bacterial, fungal and viral infections) and punctate keratitis. The following have also been reported after the use of topical corticosteroids: secondary ocular infection from pathogens liberated from ocular tissues, perforation of the globe where there is thinning of the cornea or sclera.
Cases of corneal calcification have been reported very rarely in association with the phosphate component of FML in some patients with significantly damaged corneas.

Skin and subcutaneous tissue disorders.

Rash and delayed wound healing.

General disorders and administrative site disorders.

Rare occurrences of systemic hypercorticoidism.
Reporting suspected adverse reactions after registration 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 at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Should an excess amount of drops be inadvertently administered, flush the eyes with water.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Inhibition of the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies on patient's eyes treated with both dexamethasone and fluorometholone suspensions, fluorometholone demonstrated a lower propensity to increase intraocular pressure than dexamethasone.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Liquifilm (polyvinyl alcohol) 1.4%, benzalkonium chloride 0.004%, disodium edetate, sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate heptahydrate, polysorbate 80, purified water and sodium hydroxide if needed to adjust pH.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

21 months.
Discard unused contents 4 weeks after opening.
Contents are sterile if seal is intact.

6.4 Special Precautions for Storage

Store below 25°C. Protect from freezing. Store upright.

6.5 Nature and Contents of Container

A sterile suspension in 5 mL plastic dropper bottles.
AUST R 23212.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: 9-fluoro-11β,17-dihydroxy-6α-methyl pregna-1,4-diene-3,20-dione.
Empirical formula: C22H29FO4.

CAS number.

426-13-1.

7 Medicine Schedule (Poisons Standard)

S4: Prescription Only Medicine.

Summary Table of Changes