[fluorometholone 1 mg/mL]
Consumer Medicine Information
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.
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.
Do not use FML® eye drops if:
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.
Tell your doctor if
If you have not told your doctor about this, tell them before you use FML® eye drops.
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.
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.
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.
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.
Continue using FML® eye drops for as long as your doctor prescribes.
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 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.
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.
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.
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.
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:
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.
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.
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.
The eye drops come in a 5 mL sterile plastic bottle.
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.
Allergan Australia Pty Ltd
810 Pacific Highway
Gordon, NSW 2072
Toll free: 1800 252 224 (AUS)
ABN 85 000 612 831
Allergan New Zealand Limited,
Auckland
Crn Manu Tapu Drive & Joseph Hammond Place,
Auckland International Airport
Mangere, Auckland,
New Zealand
Freephone: 0800 659 912 (NZ)
ARTG number:
AUST R 23212
Date of preparation:
April 2018
® Marks owned by Allergan, Inc
© 2018 Allergan, Inc.
sku | 9315195307072 |
---|---|
Tax Class | Taxable Goods |
Refrigeration Required | No |
Manufacturer | Allergan Australia Pty Ltd |
Poisons Schedule | S4 |
Flammable Goods | No |
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