Details for: FML 0.1%
Company: ALLERGAN INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00247855 | FML 0.1% | FLUOROMETHOLONE | 0.1 % | DROPS | OPHTHALMIC |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
FML® is used to treat inflammation of the eye.
What it does
FML® is an eye drop which contains the steroid fluorometholone, which reduces the production of substances linked to inflammation. By reducing these substances, the inflammation and pain are reduced in the eye.
When it should not be used
Do not use FML®:
- if you are allergic (hypersensitive) to fluorometholone, benzalkonium chloride, or any of the other ingredients in FML®. (See What the important nonmedicinal ingredients are), or if you are allergic to other corticosteroids
- if you have (or think you have) an infection of the eye, including a bacterial infection, a viral infection (such as herpes simplex keratitis, vaccinia, varicella), or a fungal infection or if you have tuberculosis of the eye
What the medicinal ingredient is
Fluorometholone
What the non-medicinal ingredients are
Benzalkonium chloride 0.0046% w/v (as preservative), polyvinyl alcohol, edetate disodium, sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, sodium hydroxide to adjust pH, and purified water.
What dosage form it comes in
Sterile ophthalmic suspension, fluorometholone 0.1% w/v
Warnings and precautions
This product should be used with caution in patients with a history of glaucoma .
Prolonged use may cause the pressure inside your eye (intraocular pressure) to increase.
FML® may slow healing after surgery or a wound. Contact your doctor right away if you develop further symptoms such as: eye redness, itching, tearing, discharge, feeling something in your eye, seeing floating spots or sensitivity to light.
Your sight may become blurred for a short time just after using FML®. You should not drive or use machines until your sight is clear again.
BEFORE you use FML® talk to your doctor or pharmacist if:
- you have or have ever had glaucoma (increased pressure in the eye that can lead to gradual loss of vision). FML® ophthalmic emulsion may increase the risk of glaucoma, especially when it is used for more than 10 days. Your doctor may monitor the pressure in your eyes
- you are pregnant or intend to become pregnant
- you are breastfeeding or plan to breastfeed. You should not use FML® unless your doctor determines it is appropriate for your infant as there may be a risk of harming the nursing baby
- you have an eye infection or any other eye condition
- you are allergic to fluorometholone, to any of the other ingredients, such as benzalkonium chloride, or to any of the parts of the container
- you wear contact lenses. The preservative in FML® (benzalkonium chloride) may be absorbed by and discolour soft contact lenses. Lenses should be removed prior to application of FML® and kept out for 15 minutes after use
While taking FML®
If pain and inflammation fail to improve after two days of using FML®, or if other new or worsening symptoms occur, consult your doctor.
Interactions with this medication
Tell your doctor about all the medicines you are taking including those without a prescription, vitamins, minerals and herbal products.
No drug interaction studies have been done with FML®.
Proper use of this medication
Usual adult dose and dose for children above the age of 2
Apply 1-2 drops into the conjunctival sac (a space between the lower eyelid and eye- see pictogram) two to four times daily. During the first 24 to 48 hours, the dosage may be safely increased to 2 drops every 4 hours. Use FML® for as long as your doctor tells you. Do not stop treatment early.
How to Use
The proper application of your eye drops is very important. If you have any questions ask your doctor or pharmacist.
- Shake the bottle before use. Wash your hands. Tilt your head back and look at the ceiling.
- Gently pull the lower eyelid down until there is a small pocket.
- Turn the bottle upside down and squeeze it to release one or two drops into each eye that needs treatment.
- Turn the bottle upside down and squeeze it to release one or two drops into each eye that needs treatment.
- If a drop misses your eye, try again.
- Close the cap immediately after use.
- Wipe the excess liquid from your face
- Wash your hands to remove any medication
To help prevent infections, do not let the tip of the bottle touch your eye, eyelid or anything else.
This bottle should be used by only one person, as the use by more than one person may spread infection.
If signs and symptoms fail to improve after two days of using FML®, consult your doctor.
If you develop an eye infection or other new or worsening symptoms, contact your doctor or pharmacist.
If you are using any other medication in the eye, wait at least 15 minutes before applying.
Overdose
If you accidentally use too many drops, just go back to your regular once a day dosing the next day.
Missed Dose
If you forget to apply FML® at your normal time, simply apply them as soon as you remember. Then go back to the original schedule as directed by your doctor. Don’t try to catch up on missed drops by applying more than one dose at a time.
Side effects and what to do about them
You should contact your doctor if any of the following less serious side effects become bothersome: eye irritation, redness, blurred vision, itching, tearing, taste disorder.
If an allergic (hypersensitivity) reaction occurs, with symptoms such as rash, hives, swelling of the face, lips, tongue or throat, difficulty breathing, contact your doctor.
You should see your doctor if any of the following side effects that affect the eye(s) prove troublesome or if they are long lasting:
- increased pressure inside your eye and/or glaucoma
- cataract (a loss of transparency of the lens of the eye with partial or complete loss of vision)
- new or worsening pain and/or redness of the eye
- difficulty seeing clearly
- secondary infection in the eye
- break of the eye globe
This is not a complete list of side effects. For any unexpected effects while taking FML®, contact your doctor or pharmacist.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Vision changes Blurred vision; eye swelling; eye pain; eye discharge; foreign body sensation |
✔ | ✔ | |
| New eye infection Eye redness, eye swelling, eye crusting, weeping eyes |
✔ | ✔ |
How to store
FML® should be stored between 15ºC - 25ºC. Protect from freezing.
Store it in a safe place where children cannot reach it or see it.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Allergan Inc. at: 1-800-668-6424.
This leaflet was prepared by Allergan Inc.
Last revised: May 2, 2018
©2018 Allergan Inc., Markham, ON L6G 0B5.
®Marks owned by Allergan Inc. All rights reserved.