FML 1 mg/ml eye drops suspension

1. What is FML and what is it used for

It is an eye drop, for the eyes, that contains fluorometholone as the active ingredient, a corticosteroid used to treat certain inflammatory eye disorders.

FML eye drops are indicated for the treatment of non-infectious inflammatory processes of the palpebral and bulbar conjunctiva (transparent membranes that cover the eye), the transparent membrane of the anterior part of the eye (cornea), and the anterior segment of the eye, which respond to corticosteroids.

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

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).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use FML.

• Only use this medication in your eye(s).
• You should not use FML for more than 10 days unless your doctor or ophthalmologist advises you to do so.
• 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 check your eye pressure while using this medication. You may also develop cataracts. Patients with a higher risk of hypertension and cataracts are those who are prone to them (e.g., diabetes or myopia). 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 worsen it, especially with prolonged use in eye infections with pus. If you already have a bacterial eye infection, you should consult your doctor about your treatment.
• Prolonged use of corticosteroids in the eye could lead to fungal infections in the cornea, which, if they occur, should discontinue treatment. Also, in excessive doses, they can delay the healing of eye wounds.

It is also known that ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) 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 of the eye (sclera), the use of this medication could cause corneal perforation.

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

Children

The efficacy and safety of this medication have not been demonstrated in children under 3 years of age.

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 earlier than in adults. Additionally, topical corticosteroids can cause effects on other parts of the body in children.

Other medications and FML

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

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

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. The use of FML is not recommended during pregnancy and should not be used during breastfeeding.

Driving and Using Machines

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

Do not drive or use machines until your vision is clear.

FML contains benzalkonium chloride and phosphates

This medication contains 0.046 mg of benzalkonium chloride per ml.

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

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

This medication contains 4.86 mg of phosphates per ml.

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

3. How to use FML

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

Ophthalmic 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 different instructions (see section 2).

Prolonged treatment should be avoided.

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

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

Use in Children

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

Recommendations for Use

Do not use the product if the security seal on the neck of the container is broken before using it for the first time.

Use the eye drops as follows:

1. Wash your hands and shake the container before use. Tilt your head back and look up.
2. Gently pull the lower eyelid down until a small pocket is formed.
3. Invert the bottle and squeeze it gently until 1 drop falls into the eye. Do not touch the eye or eyelid, or surrounding areas 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, gently press the edge of the eye, next to the nose, with your finger. This helps prevent the medication from entering the rest of the body.
5. Repeat steps 2 to 4 in the other eye, if it also needs treatment.

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

Replace the cap and close the container tightly immediately after use. Clean any excess liquid from your cheek with a clean cloth.

In continued treatment, the withdrawal of the medication should be done gradually, reducing the frequency of applications.

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

If you are using other ophthalmic medications, wait at least 5 minutes between the administration of this eye drop and other ophthalmic medications. Ophthalmic ointments should be administered last.

If you use more FML than you should

If you use more drops of FML than you should, it is unlikely to cause harm. If you have administered more drops than you should, rinse your 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 harm. The person affected should drink liquids to dilute.

If you forget to use FML

Do not use a double dose to make up for forgotten 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.

If you interrupt treatment with FML

FML should be used as directed by your doctor. Do not interrupt treatment until your doctor tells you to do so.

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

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not everyone experiences 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 vision loss)

Ocular irritation

Ocular redness (ocular hyperemia)

Ocular pain

Blurred vision

Ocular itching

Foreign body sensation 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 effects can also occur:

Eye effects

Lid redness (palpebral erythema)

Eye inflammation

Pupil dilation (mydriasis)

Corneal ulcers

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

Visual field defects

Corneal inflammation (keratitis)

Inflammation of the middle layer of the eye (anterior uveitis)

Ciliary muscle paralysis of the eye (cycloplegia)

Lid drooping

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

Other effects

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

Reporting Adverse Effects

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

5. Storage of FML

Keep this medication out of sight and reach of children.

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

Discard the container 28 days after opening, even if there is still product inside.

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

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

Medications should not be thrown away in drains or trash. Deposit the containers and medications you no longer need in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of FML

• The active ingredient is fluorometholone. One ml of suspension contains 1 mg of fluorometholone (0.1%).
• The other components (excipients) are: poly(vinyl alcohol), benzalkonium chloride, disodium edetate, sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate heptahydrate, polysorbate 80, sodium hydroxide (for pH adjustment), and purified water.

Appearance of the Product and Package Contents

FML is a white, sterile eye drop suspension.

It comes in a dropper container (made of plastic).

Each container contains 5 ml of eye drop suspension.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

AbbVie Spain, S.L.U.

Avenida de Burgos 91,

28050 Madrid

Spain

Manufacturer

Allergan Pharmaceuticals Ireland

Castlebar Road, Co. Mayo

Westport

Ireland

Date of the Last Revision of this Prospectus:May 2025.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/