Package Insert: Information for the User

FML 1 mg/ml Eye Drops in Suspension

fluorometolona

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What FML is and for what it is used

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

3. How to use FML

4. Possible adverse effects

5. Storage of FML

6. Contents of the package and additional information

It is an eye drop, for the eyes, that contains fluorometholone as its active ingredient, a corticosteroid used for the treatment of some inflammatory eye disorders.

FML eye drop is indicated for the treatment of non-infectious inflammatory processes of the palpebral and bulbar conjunctiva (transparent membranes covering the eye), the bulging transparent membrane at the front of the eye (cornea) and the anterior segment of the eye, which respond to corticosteroids.

Do not use FML:

- If you are allergic to fluorometholone or any of the other components of this medication (listed in section 6).

- If you have or think you have an eye infection caused by bacteria, viruses, or fungi; a corneal inflammation (keratitis) caused by herpes simplex, tuberculosis that affects the eye(s).

- If you have a corneal ulcer or any other eye condition that may be affected by the use of this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to use FML.

• Only use this medication in your eye(s).
• Do not use FML for more than 10 days unless your doctor or ophthalmologist advises you to.
• You should be cautious if you have glaucoma or are taking medication to treat high intraocular pressure. If you use this medication for a prolonged period, you may develop ocular hypertension and/or glaucoma (with optic nerve damage and decreased visual acuity). You should regularly monitor your eye pressure while using this medication. You may also develop cataracts. Patients with a higher risk (e.g., diabetes or myopia) are more likely to develop ocular hypertension and cataracts. Consult your doctor if you have any doubts.
• If your symptoms worsen, contact your doctor. You may become more sensitive to eye infections with the use of this medication. Corticosteroids can also mask the signs of an infection or intensify it, especially with prolonged use in eye infections with pus. If you already have a bacterial eye infection, consult your doctor about your treatment.
• Prolonged use of corticosteroids in the eye may cause fungal infections of the cornea, which should be suppressed if they occur. Additionally, excessive doses may delay the healing of eye wounds.

It is also known that ocular NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) may slow down or delay healing (see section "Other medications and FML").

• If you have any disease or treatment that causes thinning of the cornea or the white part of the eye (sclera), the use of this medication may cause corneal perforation.

• Contact your doctor if you experience blurry vision or other visual disturbances.

Children

This medication has not been demonstrated to be effective and safe in children under 3 years old.

The possible increase in intraocular pressure that may be caused by prolonged use of this medication is especially important in children; the risk of ocular hypertension may be higher in children and may occur before it does in adults. Additionally, topical corticosteroids may cause effects in other parts of the body in children.

Other medications and FML

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are using ocular NSAIDs. The combined use of steroids and ocular NSAIDs may increase corneal healing problems.

Some medications may increase the effects of FML, so your doctor will make close controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended for use during pregnancy.

If you are breastfeeding, your doctor should decide whether to interrupt breastfeeding or interrupt treatment with this medication, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery

You may notice that your vision becomes blurry for a while after applying the eye drops.

Do not drive or operate machinery until your vision is clear.

FML contains benzalkonium chloride and phosphates

This medication contains 0.046 mg of benzalkonium chloride in each ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove your contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in your eye after using this medication.

This medication contains 4.86 mg of phosphates in each ml.

If you have severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurry vision due to calcium accumulation.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Ocular route (in the eye/s).

The recommended dose is:

Adults and children over 3 years:

1 drop in the affected eye(s) 2 to 4 times a day. During the first 24 to 48 hours of treatment, if necessary, your doctor may recommend applying 1 drop every 4 hours.

If you have glaucoma, treatment should not exceed 2 weeks, unless your doctor has given you other instructions (see section 2).

Prolonged treatment should be avoided.

In case of continuous treatment, it should be discontinued gradually, reducing the frequency of administration.

If symptoms do not improve within 2 days, consult your doctor again.

Use in children

If this medication is used in children over 3 years, it is recommended to use the lowest dose and reduce the frequency of administration and duration of treatment.

Usage recommendations

Do not use the product if the safety seal on the neck of the container is broken before it has been used for the first time.

Use the eye drops as follows:

1. Wash your hands and shake the container before use. Incline your head back and look up.
2. Gently pull the lower eyelid down to form a small pouch.
3. Invert the bottle and press it lightly until 1 drop falls into the eye. Do not touch the eye or eyelid, nearby areas, or other surfaces with the tip of the container. The drops may become contaminated.
4. Release the lower eyelid and close the eye for 30 seconds. After using this eye drop, press gently with your finger the edge of the eye, near the nose. This helps to prevent the medication from passing into the rest of the body.
5. Repeat steps 2 to 4 in the other eye, if also needed treatment.

If a drop does not fall into the eye, try again.

Replace the cap and close the bottle tightly immediately after use. Wipe away any excess liquid from your cheek with a clean tissue.

In continuous treatment, the medication should be discontinued gradually by reducing the frequency of applications.

If you are using another eye drop, wait at least 5 minutes before using FML.

When using other eye medications, wait at least 5 minutes between the administration of this eye drop and the other eye medications. Eye ointments should be administered last.

Using more FML than you should

If you use more drops of FML than you should, it is unlikely to cause harm. If more drops than you should have been administered, rinse the eye with plenty of warm water. Do not apply more drops until the next scheduled dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If someone accidentally ingests FML, it is unlikely to cause any harm. The affected person should drink liquids to dilute.

If you forget to use FML

Do not use a double dose to make up for missed doses.

If you have forgotten a dose, use FML as soon as possible, unless it is almost time for the next scheduled dose. In this case, apply the next dose at the usual time.

Stopping treatment with FML

FML should be used according to your doctor's instructions. Do not stop treatment until your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been observed with this medication. The frequency cannot be estimated from the available data:

Eye Effects

Unknown frequency:

Increased pressure inside the eye and/or glaucoma

Cataracts (loss of transparency of the eye lenses with loss of vision)

Ocular irritation

Eye redness (ocular hyperemia)

Eye pain

Blurred vision

Itchy eyes

Sensation of a foreign body in the eye

Swelling of the eyelid or eye

Ocular discharge

Excessive tearing

General Effects

Unknown frequency:

Bad taste, skin rash, allergic reaction (hypersensitivity).

During treatment with corticosteroids in the eyes, the following may also occur:

Eye Effects

Redness of the eyelid (erythema palpebrum)

Eye inflammation

Excessive dilation of the pupil (mydriasis)

Ulcers on the surface of the eye (on the cornea)

Ocular infection (including bacterial, fungal, or viral infections)

Visual field defects

Corneal inflammation (keratitis)

Anterior uveitis (inflammation of the middle layer of the eye)

Cycloplegia (paralysis of the ciliary muscle of the eye)

Ptosis (drooping eyelid)

Thinning of the sclera (white of the eye) or cornea.

Other Effects

Rare cases of Cushing's syndrome (body and facial swelling and weight gain).

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C. Do not freeze.

Dispose of the container 28 days after opening, even if there is product remaining.

Keep the container tightly closed to prevent contamination and store in an upright position.

Do not use this medication after the expiration date that appears on the container after CAD/EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown away through drains or in the trash. Deposit containers and unused medications at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of FML

• The active principle is fluorometolone. One milliliter of suspension contains 1 mg of fluorometolone (0.1%).
• The other components (excipients) are: poly(vinyl alcohol), benzalkonium chloride, disodium edetate, sodium chloride, dihydrogen phosphate monohydrate of sodium , heptahydrate of sodium hydrogen phosphate, polisorbate 80, sodium hydroxide (to adjust pH) and purified water.

Appearance of the product and contents of the packaging

FML is a suspension eye drop, white, sterile.

It is presented in a dropper bottle (plastic).

Each container contains 5 ml of suspension eye drop.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid

Spain

Responsible for manufacturing

Allergan Pharmaceuticals Ireland

Castlebar Road, Co. Mayo

Westport

Ireland

Last review date of this leaflet: May 2018.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/