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Fluorometholone (FML) 0.1% Liquid 5ml

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Product info

Fluorometholone (FML) 0.1% Liquid 5ml

Description:

FML® EYE DROPS

[fluorometholone 1 mg/mL]


Consumer Medicine Information

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

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

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.

Delivery info

Please note that Public Holidays will add on extra delivery time for orders

SuperPharmacy orders will be packaged in plain, impervious packaging that is unmarked for security and privacy reasons. Orders will be dispatched as soon as possible once payment is received. 

We will dispatch most orders within business day from Monday to Friday, assuming all items are in stock. All other orders will be dispatched as quickly as possible thereafter.

For Orders containing prescription items please see the prescription processing procedure.

 

Australia Wide shipment details

We offer Standard Shipping for $4.95** with approximately 4-8 business days of transit time based upon your location within Australia.*

We also offer an Express Delivery Service for $10.95** with approximately 1-3 business days of transit time based upon your location within Australia.*

All Australian orders $99 or more in value will qualify for FREE Standard Shipping or Express Delivery at $7.95

Any orders that contain an item that requires Cold-Chain Shipping will incur a $10.95 Express Delivery Fee. This will overwrite any other thresholds.

Any orders over 5kgs will have our Online Team be in contact with further information regarding shipping.

All orders of Prescription items will receive FREE Delivery regardless of order value.

*These estimations are based upon transit time once dispatched from our locations. Please note our couriers do not operate on weekends and public holidays.

**These delivery costs do not represent orders that we consider 'Bulk Orders'.  Bulk Orders will have our Online Team be in touch in order to discuss appropriate shipping costs. For clarification on what we classify as a 'Bulk Order', refer to our terms and conditions or give us a call.

 

Sending a Prescription to SuperPharmacy.

When you purchase prescription medication online with SuperPharmacy, we need a valid script in our possession before we can dispatch your medications to you. 

For Electronic Prescriptions, it is now as easy as sending your Token to epharmacist@superpharmacy.com.au.

For Paper Prescriptions, we still require the physical paperwork in our possession, so they can only be processed once we physically receive your prescription paperwork. Prescription product orders will be dispensed and dispatched on the business day the prescription or valid repeat authorisation is received at the SUPERPHARMACY registered premises. Please send your prescription paperwork to the appropriate store

NSW, ACT and TAS:  SUPERPHARMACY PO Box 1877 Hornsby Westfield 1635

QLD or NT: SuperPharmacy 5/17 Billabong St, Stafford QLD, 4053

SA: SuperPharmacy 41 Hindley street Adelaide, SA 5000

VIC: SuperPharmacy 92 Lygon Street East Brunswick VIC 3057

WA: SuperPharmacy 259 Walcott St, North Perth WA 6006

 

Can I send a photo of my Script?

A photo is only valid for Electronic Prescriptions. For traditional Paper Prescriptions, we will need you to post the script to us as highlighted above.

Postage and handling for international orders

We do not currently deliver outside of Australia 

Returns & exchanges

How Do Returns & Refunds Work?


We are happy to offer refunds or exchanges on any item (excluding restricted items*) that you have purchased from us.

Important: You are not entitled to, or guaranteed, a refund for Change of Mind returns. They will be processed at our discretion. We reserve the right to charge a restocking fee for Change of Mind returns.
You will be responsible for the cost of shipping to return goods to us unless we specify that we will cover the cost.

Note: Legislation prohibits us from accepting Prescription Items for refund or exchange.

 

All we ask is that you follow the below to qualify:

  1. Check your products as soon as you receive delivery. Ensure the correct items have been sent, and nothing is damaged or in an unusable condition.
     
  2. Contact us within 30 days from your order date (7 days for damaged/incorrect items).
     

How We Handle Them:
 

Change of Mind

  • If you've had a change of mind about an item you have ordered, we'll need to receive it back to us unopened and unused, in the original packaging.
     

Faulty Item

  • If the item you have received is faulty, please contact us with a detailed description of the product fault, alongside a photo if possible.

 

Allergic Reaction

  • In the rare instance you've had an allergic reaction to a product, please discontinue use of the product immediately. We may reach out for further information on the reaction.

Allergy returns must be less than 20% used upon arrival back to us.
 

Incorrect / Damaged Items

  • If you have received an item that isn't what you ordered, or it arrived damaged, please take a photo and contact us within 7 days of delivery. 

Please don't dispose of the item without informing us.

 

The Process:

  1. Contact Us

    • To start a return, please send your request to customerservice@superpharmacy.com.au. Make sure we have received & acknowledged your request before you send the item back to us.
       
  2. Instructions

    • A Customer Service Team Member will then review your request, and be in touch with some further information. Should your request be approved, they will supply a return address for you to post the item back to us, and instructions on how to do so.
       
  3. Drop Off At Your Post Office

    • Once you have received the returns address and packaged and labelled your box as instructed, all you need to do is drop off the parcel at your local Post Office. From there, they will take care of getting the parcel back to us.
       
  4. We Receive Your Return

    • It can take anywhere from an estimated 1-10 business days for us to receive your return parcel back to us (depending on location). We check for any returns daily and will process the refund/exchange within 2 business days after receiving the item back to us. We will make sure the entire process is communicated to you once we receive the item back.

 

 

Am I Eligible For Free Return Shipping?

If you qualify for free return shipping, our Customer Service Team will make this clear to you in your request. Unfortunately, we are not able to cover return postage fees on all return types.

 

What Items Are Restricted For Returns*?

We will not accept Change of Mind Returns for the following items:

  • Baby Formula
  • Prescription Medicine
  • Perfumes & Colognes
  • Bulk / Special Orders