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FML LIQUIFILM OPHTHALMIC 1 MG / ML EYE DROPS SUSPENSION - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - FML LIQUIFILM OPHTHALMIC 1 MG / ML EYE DROPS SUSPENSION

5. how to store 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.

After opening do not use this bottle for more than 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 informationwhat fml containsthe 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:

Allergan Limited

Marlow International

The Parkway

Marlow

Bucks

SL7 1YL

UK

Manufacturer:

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland

This leaflet was last revised in June 2020.

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 00426/0028.

This is a service provided by the Royal National Institute of Blind People.

— ALLERGAN

© 2020 Allergan, Inc., Irvine CA 92612

® Marks owned by Allergan, Inc. 72073MD215M

^@ALLERGAN

Package leaflet:

Information for the user

FML®LIQUIFILM®

OPHTHALMIC 1 mg/ml

EYE DROPS SUSPENSION

Fluorometholone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • – Keep this leaflet. You may need to read it again.

  • – If you have further questions, please ask your doctor or your pharmacist.

  • – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • – If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet:

  • 1. What FML is and what it is used for

  • 2. What you need to know before you use FML

  • 3. How to use FML

  • 4. Possible side effects

  • 5. How to store FML

  • 6. Contents of the pack and other information

1. what fml is and what it is used for

FML is an eye drops. It contains a steroid which is used to treat inflammation of the eye.

2. what you need to know before you use fmldo 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.

3. How to use FML


Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist 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 advises it. During the first 24 – 48 hours of treatment your doctor 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.





4.



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.


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 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

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 side effects not listed in this leaflet.

You can also report side effects directly via Yellow Card Scheme, Website:. By reporting side effects you can help provide more information on the safety of this medicine.


Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

S SENSORY ORGAN DRUGS

S01 OPHTHALMOLOGICALS

S01B ANTIINFLAMMATORY AGENTS, OPHTHALMOLOGIC

S01BA Corticosteroid ophthalmologic antiinflammatory agents, plain

S01BA07 fluorometholone

Frequently Asked Questions

What are FML Liquifilm eye drops used for?

FML Liquifilm eye drops are used to treat inflammation and pain in the eyes caused by various conditions, such as allergies or surgery.

How does fluorometholone work in FML Liquifilm?

Fluorometholone works by reducing inflammation and suppressing the immune response in the eye, helping to relieve symptoms.

Can I use FML Liquifilm if I wear contact lenses?

It is recommended to remove contact lenses before using FML Liquifilm and wait at least 15 minutes before reinserting them.

How often should I use FML Liquifilm eye drops?

Your doctor will determine the appropriate dosage, but generally, it's prescribed to be used 2-4 times a day.

Can children use FML Liquifilm eye drops?

FML Liquifilm is usually not recommended for children under 2 years of age; consult your doctor for specific advice.

What should I do if I miss a dose of FML Liquifilm?

If you miss a dose, apply it as soon as you remember. If it's close to your next dose, skip the missed one and continue with your regular schedule.

Is it safe to use FML Liquifilm during pregnancy?

Consult your doctor before using FML Liquifilm if you are pregnant or breastfeeding, as they will assess the risks and benefits.

Are there any side effects of FML Liquifilm eye drops?

Possible side effects include temporary burning or stinging upon application, increased intraocular pressure, or blurred vision. Contact your doctor if side effects persist.

Can I use other eye medications while using FML Liquifilm?

Inform your doctor about all other eye medications you are using to avoid potential interactions. It's usually advised to space out the doses.

What should I do if I experience an allergic reaction to FML Liquifilm?

If you experience symptoms like rash, itching, or swelling around the eyes or face, seek medical attention immediately.

How should I store FML Liquifilm eye drops?

Store the eye drops at room temperature, away from direct sunlight, and keep them tightly closed when not in use.

Can I drive after using FML Liquifilm?

You may experience blurry vision immediately after using the drops; wait until your vision clears before driving or operating machinery.

What happens if I overdose on FML Liquifilm eye drops?

Using more than recommended may increase side effects. If you suspect an overdose, contact your healthcare provider for guidance.

Will FML Liquifilm affect my ability to wear makeup?

It’s best to avoid applying makeup around the eyes while using FML Liquifilm; wait until your treatment is finished for best results.

Can I drink alcohol while using FML Liquifilm?

There are no known interactions with alcohol; however, it's always best to consult your healthcare provider for personalized advice.

How long can I use FML Liquifilm without consulting my doctor again?

Do not use it longer than prescribed without consulting your healthcare provider, even if symptoms improve.

Is there anyone who should not use FML Liquifilm eye drops?

People with certain viral infections of the eye (such as herpes) or those with allergy to fluorometholone should avoid using these drops.

What is the shelf life of opened FML Liquifilm eye drops?

After opening, it is typically recommended to discard any unused portion after 28 days. Always check with your pharmacist for specific guidance.

Are there online resources for more information on FML Liquifilm eye drops?

Yes, reputable health websites and pharmacy resources provide detailed information about usage, side effects, and FAQs regarding medications like FML Liquifilm.