Package Leaflet: Information for the User

ISOPTO FLUCON 1mg/ml eye drops in suspension

Fluorometolone

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What ISOPTO FLUCON is and what it is used for

2.What you need to know before you start using ISOPTO FLUCON

3.How to use ISOPTO FLUCON

4.Possible side effects

5Storage of ISOPTO FLUCON

6.Contents of the pack and other information

It is an eye drop suspension that contains fluorometolone, a corticosteroid used in the treatment of some ocular inflammatory disorders as an active ingredient.

Isopto Flucon is indicated for the treatment of non-infectious inflammatory processes of the anterior segment of the eye, the cornea, and the palpebral and bulbar conjunctivas (transparent membranes that cover the eye).

Due to its particular characteristics, it is especially recommended for processes that require the use of corticosteroids for a longer period than usual.

No use ISOPTO FLUCON:

• 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:

• Untreated bacterial eye infection.
• Corneal inflammation (keratitis) caused by herpes simplex or any other viral eye infection such as smallpox or chickenpox.
• Tuberculosis that affects the eye.
• Fungal eye infections.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Isopto Flucon.

• Only use this medication in your eye(s).

• If you use this medication for a long period of time, you may:

• Develop high eye pressure and/or glaucoma (with optic nerve damage and decreased visual acuity). You should regularly control your eye pressure while using this medication. Consult your doctor if you have any doubts. The risk of elevated intraocular pressure and/or corticosteroid-induced cataract formation is higher in patients prone to it (e.g. diabetes). Children may have a higher probability of developing elevated intraocular pressure.
• Develop cataracts. You should visit your doctor frequently.

• If you have glaucoma (high eye pressure) or a family history of glaucoma. Your doctor should regularly control your eye pressure (intraocular pressure).
• If you have diabetes. You may have a higher risk of developing high eye pressure or cataracts (opacity of the eye's crystalline lens).
• If your symptoms worsen or return suddenly, 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 pus-containing eye infections.
• If you already have a bacterial eye infection, consult your doctor about your treatment.
• The prolonged use of corticosteroids in the eye may produce fungal infections of the cornea. In case of occurrence, treatment should be suppressed. If you experience intense eye pain, persistent reduced vision, or a sensation of having something in your eye (severe persistent ulcers) on the surface of your eye (cornea), report to your doctor to rule out a fungal infection.
• The use of corticosteroids in the eye in excessive doses may delay the healing of the same eye injuries. It is also known that topical NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) may slow down or delay healing (see "Other medications and Isopto Flucon").
• If you suffer from a condition causing thinning of the ocular tissue (the outer layers of the eye), the use of this medication may cause corneal perforation.
• Contact your doctor if you experience blurry vision or other visual disturbances.
• The systemic side effects of corticosteroids include swelling around the trunk and in the facial area accompanied by weight gain. This type of side effect may occur when a corticosteroid is absorbed into the bloodstream and after prolonged and continuous treatment with corticosteroids. Side effects may occur in patients at higher risk, such as children, and patients treated with medications containing ritonavir or cobicistat (see section "Other medications and Isopto Flucon"). Talk to your doctor if you experience swelling around the trunk and in the facial area with weight gain.

If you use contact lenses:

• Wearing contact lenses (hard or soft) is not recommended during treatment of eye inflammation.

Children

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

The possible increase in intraocular pressure associated with the prolonged use of this medication is especially important in pediatric patients; the risk of corticosteroid-induced glaucoma may be higher in children and occur before it does in adults. Additionally, topical corticosteroids, including fluorometholone, may cause a delay in growth in children.

Other medications and ISOPTO FLUCON

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 topical NSAIDs (Nonsteroidal Anti-Inflammatory Drugs). The combined use of steroids and topical NSAIDs may increase the problems of corneal healing.

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

Pregnancy, lactation, and fertility

The use of Isopto Flucon is not recommended during pregnancy.

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

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

Driving and operating machines

You may notice that your vision becomes blurry for a while after applying the eye drops in your eyes. Do not drive or operate machines until this effect has disappeared.

Isopto Flucon contains benzalkonium chloride and phosphates

This medication contains 0.1 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 putting them back in.

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 2.8 mg of phosphates in each ml.

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

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

Ophthalmic route (in the eye/eyes).

The recommended dose is:

Adults and children over 3 years old

1 drop in the affected eye(s) 2 to 4 times a day.

If necessary, this dose can be administered every 4 hours during the first 24-48 hours of treatment.

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, consult your doctor again.

Use in children

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

Use in patients over 65 years old

Patients over 65 years old can use this medication at the same dose as adults.

Usage recommendations:

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• Wash your hands.
• Take the bottle (dropper bottle).
• Shake well before use.
• After opening the bottle for the first time, remove the plastic ring from the seal if it is loose.
• Hold the bottle, upside down, between your fingers (figure 1).
• Incline your head back. Gently separate your eyelid from your eye with a finger, until a pouch forms, where the drop should fall (figure 2).
• Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
• Do not touch your eye or eyelid, nearby areas or other surfaces with the dropper. The drops could become contaminated.
• Press gently on the base of the bottle with your index finger to release one drop at a time (figure 3). After using this eye drop, press gently on the edge of your eye, near your nose. This helps to prevent the medication from passing into the rest of your body, which reduces general side effects that affect other parts of your body (figure 4).
• If you apply drops to both eyes, repeat all previous steps for the other eye.
• Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

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

When using more Isopto Flucon than you should

A drop overdose in the eyecan be eliminated by rinsing the eye with warm water. Do not apply more drops until the next dose.

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

When you forget to use Isopto Flucon

Do not apply a double dose to compensate for the missed doses.

Apply a single dose as soon as you remember and continue with the next dose scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen.

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 all people may experience them.

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

• Eye effects: increased eye pressure and/or glaucoma, blurred vision, eye pain, eye discomfort, abnormal sensation in the eye, eye irritation, eye redness, increased tear production.

• General effects: bad taste.

The prolonged use of corticosteroids in the eyes may also cause:

• Increased eye pressure with optic nerve damage and decreased visual acuity.
• Cataract formation.
• Delayed corneal healing.
• In diseases that cause corneal thinning, there is a greater risk of perforation.

Corticosteroids may reduce resistance to eye infections, favoring their appearance.

Additionally, the following adverse effects have been observed with the use of corticosteroid eye drops in general:

• Eye effects: transient burning sensation, fluid retention in the eyelid (palpebral edema), eyelid redness (palpebral erythema), acute anterior uveitis, paralysis of the ciliary muscle of the eye (cycloplegia), pupil dilation, eyelid drooping, thinning of the sclera (white of the eye) after prolonged use, and keratitis (corneal inflammation).

• General effects: hypersensitivity (allergy), rare cases of Cushing's syndrome (body and facial swelling and weight gain), and skin eruptions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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 30°C.

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

To prevent infections, discard the bottle 4 weeks after it has been opened for the first time.

Note the date of opening the bottle in the reserved box on the box.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and medicines you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you do not need. By doing so, you will help protect the environment.

Composition of Isopto Flucon

• The active principle is fluorometholone. One ml of suspension contains 1 mg of fluorometholone (0.1%).

• The other components are: benzalkonium chloride, disodium edetate, monobasic sodium phosphate monohydrate, anhydrous sodium hydrogen phosphate, hypromellose, polysorbate 80, sodium chloride, polyvinyl alcohol, hydrochloric acid and/or sodium hydroxide (to adjust the pH) and purified water

Appearance of the product and contents of the packaging

Isopto Flucon is a white or slightly yellowish eye drop suspension.

It is presented in a dropper bottle (plastic bottle with a screw cap). Each container contains 5 ml of eye drops.

Holder of the marketing authorization

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Responsible for manufacturing

Siegfried El Masnou, S.A

C/ Camil Fabra, 58

08320 El Masnou-Barcelona, Spain

Last review date of this leaflet:October 2017.

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