Isopto Flucon 1 mg/ml suspension for eye drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ISOPTO FLUCON 1 mg/ml eye drops in suspension

Fluorometholone

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before using ISOPTO FLUCON

3. How to use ISOPTO FLUCON

4. Possible side effects

5. Storage of ISOPTO FLUCON

6. Contents of the pack and other information

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

It is an ophthalmic suspension eye drop containing fluorometholone as the active substance, a corticosteroid used in the treatment of certain inflammatory ocular disorders.

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

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

2. What you need to know before using ISOPTO FLUCON

Do not use ISOPTO FLUCON:

• If you are allergic to fluorometholone or to any of the other ingredients of this medicine (listed in section 6).

• If you have or think you have:

• Untreated bacterial eye infection.

• Herpes simplex keratitis (corneal inflammation) or any other viral eye infection such as smallpox or varicella.

• Tuberculosis affecting the eye.

• Fungal diseases (fungal infections) of the eye.

Warnings and precautions

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

• Use this medicine only in your eye(s).

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

• Develop ocular hypertension and/or glaucoma (with optic nerve damage and reduced visual acuity). You should have your eye pressure monitored regularly while using this medicine. Consult your doctor if in doubt. The risk of elevated intraocular pressure and/or corticosteroid-induced cataract formation is higher in predisposed patients (e.g., diabetes). Children may be more likely to develop elevated 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 monitor your eye pressure (intraocular pressure) regularly.

• If you have diabetes. You may have an increased risk of developing high eye pressure or cataracts (clouding of the eye's lens).

• If your symptoms worsen or return suddenly, contact your doctor. You may become more susceptible to eye infections while using this medicine. Corticosteroids may also mask signs of infection or worsen it, especially with prolonged use in purulent eye infections.

• If you already have a bacterial eye infection, consult your doctor about appropriate treatment.

• Prolonged use of corticosteroids in the eye may lead to fungal infections of the cornea. If this occurs, treatment should be discontinued. If you experience severe eye pain, persistent reduced vision, or a sensation of a foreign body in the eye (persistent severe corneal ulcers), inform your doctor to rule out a fungal infection.

• Excessive use of corticosteroids in the eye may delay healing of eye wounds. Ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are also known to slow or delay healing (see section "Other medicines and Isopto Flucon").

• If you have a condition causing thinning of ocular tissue (the outer layers of the eye), using this medicine could lead to corneal perforation.

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

• Systemic side effects of corticosteroids include swelling around the trunk and face accompanied by weight gain. These types of side effects may occur when a corticosteroid is absorbed into the bloodstream, particularly after prolonged and long-term corticosteroid treatment. Side effects may occur more frequently in high-risk patients, such as children, and in patients taking medications containing ritonavir or cobicistat (see section “Other medicines and Isopto Flucon”). Talk to your doctor if you experience swelling around the trunk and face with weight gain.

If you wear contact lenses:

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

Children

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

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

Other medicines and ISOPTO FLUCON

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are using ophthalmic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). 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 certain HIV medications: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

Use of Isopto Flucon during pregnancy is not recommended.

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

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

Driving and use of machines

You may notice that your vision becomes blurred for a short time after applying the eye drops. Do not drive or operate machinery until this effect has passed.

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 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 foreign body sensation, stinging, 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 at the front of the eye), treatment with phosphates, in very rare cases, may cause blurred vision due to calcium accumulation.

3. How to use ISOPTO FLUCON

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Ophthalmic use (in the eye[s]).

Recommended dose:

Adults and children over 3 years of age

1 drop into the affected eye(s) 2 to 4 times daily.

If required, this dose may 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.

If continued treatment is necessary, it should be discontinued gradually by reducing the frequency of administration.

If symptoms do not improve within two days, 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 both the frequency and duration of treatment.

Use in patients over 65 years of age

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

Instructions for use:

1 2 3 4

• Wash your hands.
• Take the bottle (dropper container).
• Shake well before use.
• After opening the bottle for the first time, remove the loose plastic ring of the seal if present.
• Hold the bottle upside down between your fingers (figure 1).
• Tilt your head backwards. Gently pull down the eyelid to form a pouch, into which the drop should fall (figure 2).
• Bring the tip of the bottle close to the eye. Using a mirror may help.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip, as the drops could become contaminated.
• Gently squeeze the base of the bottle with your index finger to release one drop at a time (figure 3). After instilling the eye drops, gently press with your finger on the inner corner of the eye, near the nose. This helps prevent the medicine from draining into the rest of the body, thereby reducing the risk of systemic side effects (figure 4).
• If applying drops to both eyes, repeat all the previous steps for the other eye.
• Close the bottle tightly immediately after use.

If a drop misses the eye, try again.

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

If you use more Isopto Flucon than you should

An overdose in the eyes can be removed by rinsing the eyes with lukewarm water. Do not apply further drops until the next scheduled dose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 missed doses.

Apply a single dose as soon as you remember, and then continue with your next scheduled dose. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed with this medicine. 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 may also cause:

• Increased intraocular pressure with damage to the optic nerve and decreased visual acuity.
• Cataract formation.
• Delayed healing of the cornea.
• In diseases causing corneal thinning, there is an increased risk of perforation.

Corticosteroids may reduce resistance to ocular infections, thereby favoring their development.

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

• Eye effects: transient burning sensation, eyelid swelling (palpebral edema), eyelid redness (palpebral erythema), inflammation of the middle layer of the eye (anterior acute uveitis), paralysis of the eye's ciliary muscle (cycloplegia), pupil dilation, drooping eyelid, thinning of the sclera (white of the eye) after prolonged use, and keratitis (inflammation of the cornea).

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 the carton after EXP. The expiry date refers to the last day of the month indicated.

To prevent infection, discard the bottle 4 weeks after first opening.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Isopto Flucon

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

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

Appearance of the product and contents of the pack

Isopto Flucon is a white or slightly yellowish ophthalmic suspension.

It is supplied in a dropper container (plastic bottle with screw cap). Each pack 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 the most recent revision of this leaflet: October 2017.

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