ISOPTO FLUCON 1 mg/ml EYE DROPS IN SUSPENSION

2. What you need to know before you use ISOPTO FLUCON

Do not use ISOPTO FLUCON:

• If you are allergic to fluorometholone or any of the other ingredients of this medicine (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 diseases.

Warnings and precautions

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

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

• If you use this medicine for a long time, you may:

• Develop high eye pressure and/or glaucoma (with optic nerve damage and decreased visual acuity). You should regularly check the pressure in your eye while using this medicine. Consult your doctor if you have any doubts. The risk of increased intraocular pressure and/or cataract formation induced by corticosteroids is higher in patients who are prone to it (e.g., diabetes). Children may have a higher likelihood of developing high intraocular pressure.
• Develop cataracts. You should visit your doctor frequently.

• If you have glaucoma (high pressure in the eyes) or a family history of glaucoma. Your doctor should regularly check the pressure in your eyes (intraocular pressure).
• If you have diabetes. You may have a higher risk of developing high eye pressure or cataracts (opacity of the eye's lens).
• If your symptoms worsen or return suddenly, contact your doctor. You may become more sensitive to eye infections with the use of this medicine. 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. If this occurs, treatment should be discontinued. If you experience severe eye pain, persistent blurred vision, or a feeling of having something in your eye (severe persistent ulcers) on the surface of your eye (cornea), inform your doctor to rule out a fungal infection.
• The use of corticosteroids in the eye in excessive doses can delay the healing of eye wounds. It is also known that ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs) slow down or delay healing (see section "Other medicines and Isopto Flucon").
• If you suffer from a disorder that causes thinning of the eye tissue (the outermost layers of the eye), the use of this medicine could lead to corneal perforation.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• The systemic side effects of corticosteroids include swelling around the trunk and in the face area accompanied by weight gain. This type of side effect can occur when a corticosteroid is absorbed into the bloodstream and after prolonged and long-term treatment with corticosteroids. Side effects may occur in patients at higher risk, such as children, and patients treated with medicines that contain ritonavir or cobicistat (see section "Other medicines and Isopto Flucon"). Talk to your doctor if you experience swelling around the trunk and in the face area with weight gain.

If you wear contact lenses:

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

Children

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

The possible increase in intraocular pressure associated with the prolonged use of this medicine is especially important in pediatric patients; the risk of corticosteroid-induced ocular hypertension may be higher in children and occur earlier than in adults. Additionally, topical corticosteroids, including fluorometholone, may cause growth retardation in children.

Other medicines and ISOPTO FLUCON

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

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

Pregnancy, breastfeeding, and fertility

The use of Isopto Flucon is not recommended during pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

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

Isopto Flucon contains benzalkonium chloride and phosphates

This medicine contains 0.1 mg of benzalkonium chloride per ml.

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

Benzalkonium chloride may 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 a strange sensation, itching, or pain in the eye after using this medicine.

This medicine contains 2.8 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 ISOPTO FLUCON

Follow the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Ophthalmic route (in the eye/eyes).

The recommended dose is:

Adults and children over 3 years

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

Use in children

If this medicine 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.

Use in patients over 65 years of age

Patients over 65 years of age can use this medicine at the same dose as adults.

Recommendations for use:

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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).
• Tilt your head back. Gently separate the eyelid from the eye with a finger, until a pouch forms, where the drop should fall (figure 2).
• Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.
• Do not touch the eye or eyelid, or nearby areas, with the dropper. The drops could become contaminated.
• Gently press the base of the bottle with your index finger to release one drop at a time (figure 3). After using this eye drop, gently press the edge of the eye, next to the nose, with your finger. This helps prevent the medicine from passing into the rest of the body, which reduces general side effects that affect other parts of the body (figure 4).
• If you are applying drops to both eyes, repeat all the previous steps with the other eye.
• Close the bottle tightly immediately after use.

If a drop falls outside the eye, try again.

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

If you use more ISOPTO FLUCON than you should

An overdose in the eyes can be eliminated by rinsing the eyes with lukewarm 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to use ISOPTO FLUCON

Do not apply a double dose to make up for forgotten doses.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Eye effects: increased pressure in the eye 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.

Prolonged use of corticosteroids in the eyes can also cause:

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

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

Additionally, the following side effects have been observed with the use of ophthalmic corticosteroids in general:

• Eye effects: transient burning sensation, fluid retention in the eyelid (eyelid edema), eyelid redness (eyelid erythema), inflammation of the middle layer of the eye (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 (swelling and weight gain of the body and face) and skin rashes.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es.By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of ISOPTO FLUCON

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the bottle and carton after EXP. The expiry date is the last day of the month indicated.

To avoid infections, you should discard the bottle 4 weeks after opening it for the first time.

Write the date of opening of the bottle in the space provided for this purpose on the carton.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Isopto Flucon

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

• The other ingredients are: benzalkonium chloride, disodium edetate, sodium phosphate monobasic 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 and packaging of the product

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

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

Marketing authorization holder

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Manufacturer

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou-Barcelona, Spain

Date of last revision of this package leaflet:October 2017.

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