Flucon

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Flucon

1 mg/ml (0.1%), eye drops, suspension

Fluorometholone

You should read the leaflet carefully before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Flucon and what is it used for
• 2. Important information before using Flucon
• 3. How to use Flucon
• 4. Possible side effects
• 5. How to store Flucon
• 6. Contents of the pack and other information

1. What is Flucon and what is it used for

Flucon is used to treat non-infectious inflammatory conditions of the eye.

Flucon belongs to a group of medicinescalled corticosteroids. Their action is to prevent or reduce inflammation.

2. Important information before using Flucon

When not to use Flucon eye drops

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has:
• untreated acute bacterial eye infection,
• herpetic keratitis, chickenpox, shingles, or any other viral eye infection,
• fungal eye infection,
• tuberculous eye infection,
• untreated purulent eye infection.

Warnings and precautions

• Flucon should only be used for eye drops (eyes).
• If the patient uses Flucon eye drops for a long period:
• The patient may experience an increase in eye pressure. The risk of corticosteroid-induced increased eye pressure is higher in children and may occur faster than in adults. Especially when using the medicine in children, you should consult a doctor for advice. The risk of developing ocular hypertension and cataract formation due to corticosteroid use is also higher in patients with other diseases (e.g., patients with diabetes).
• The patient may develop glaucoma with optic nerve damage, decreased visual acuity, and visual field disturbances, as well as posterior subcapsular cataract formation.
• If symptoms worsen or an acute relapse occurs, the patient should contact a doctor. The patient may be more susceptible to eye infections.
• If an infection occurs, the doctor will prescribe another medicine to treat the infection.
• Topical corticosteroids may delay the healing of eye wounds. Concurrent topical use of non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of eye healing problems.
• If the patient has diseases that lead to thinning of the eye tissues, they should consult a doctor or pharmacist before using this medicine.
• If the patient is using other medicines, they should carefully read the section "Flucon and other medicines".
• If the patient experiences blurred vision or other vision disturbances, they should contact a doctor.

Special caution is required when using fluorometholone in the treatment of

herpes simplex virus( herpes simplex). The patient should consult a doctor for advice if their condition worsens or does not improve.
Topical corticosteroid administration may be associated with decreased cortisol secretion in the urine as well as decreased cortisol levels in the blood. An association between corticosteroids and decreased growth rate in children has been observed, especially at high doses and with prolonged treatment. Before starting Flucon, the patient should discuss this with their doctor or pharmacist.

Children

The safety of using Flucon in children under 3 years of age has not been established, so it is not recommended for this age group.

Flucon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. If the patient is using other eye drops or ointments, they should wait at least 5 minutes between administrations of the different medicines. Eye ointments should be used last.
Concurrent topical use of corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of eye healing problems. No interaction studies have been conducted.
When using eye drops intended to dilate the pupil (e.g., atropine), which can cause increased intraocular pressure, this effect may be enhanced when Flucon is used at the same time.
Corticosteroid eye medicines may cause increased intraocular pressure, reducing the effectiveness of glaucoma medicines.
Some medicines may enhance the effect of Flucon, so the doctor may decide to carefully monitor the patient's condition when taking these medicines (including certain HIV medicines: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Driving and using machines

Flucon has no or negligible influence on the ability to drive and use machines.
For a while after administering Flucon, vision may be blurred. The patient should not drive or operate machines until this symptom subsides .

Flucon contains benzalkonium chloride

The medicine contains 0.5 mg of benzalkonium chloride in every 5 milliliters of suspension, which corresponds to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove contact lenses before administering the drops and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations occur in the eye, stinging, or pain in the eye after using the medicine, the patient should contact a doctor.

Flucon contains phosphates

Flucon eye drops contain 8.5 mg of monosodium phosphate monohydrate and 12.5 mg of disodium phosphate in every 5 milliliters of suspension, which corresponds to 2.8 mg of phosphates/ml.
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposition during treatment.

3. How to use Flucon

This medicine should always be used as directed by the doctor.
If in doubt, the patient should consult a doctor or pharmacist.
If the protective cap is loosened after removing the cap, it should be discarded before using the medicine.
Adolescents and adults (including elderly patients)
The usual dose of Flucon is one drop into the eye or eyes, two to four times a day. During the first 24 to 48 hours, the doctor may increase the dosage to one drop every 4 hours. The doctor will inform how long the treatment will last.
Children
The safety of using Flucon in children under 3 years of age has not been established.
The doctor will determine how long to use the medicine.
If the medicine is used in patients with glaucoma, the treatment period should be limited to 2 weeks, unless longer treatment is justified.
Flucon is onlyintended for administration into the eye.

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How to use the eye drops

• 1. Prepare the bottle of eye drops and a mirror.
• 2. Wash your hands thoroughly.
• 3. Shake the bottle well.
• 4. Unscrew the cap.
• 5. Hold the bottle in your hand and turn it upside down, holding it with your thumb and middle finger (drawing 1).
• 6. Tilt your head back. Pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eyeball; the drop should fall into this pocket (drawing 2).
• 7. Bring the tip of the bottle close to the eye. You can use a mirror to help.
• 8.

Do not touch the dropper tip to the eye, eyelid, or surrounding areas.

This could cause infection of the drops.

• 9. Gently squeeze the bottom of the inverted bottle to release a single drop of Flucon (drawing 3).
• 10. After using the eye drops, remove the finger that held the lower eyelid. Close your eye and gently press the corner of your eye near your nose for 2 minutes (drawing 4). This will help prevent the medicine from entering the entire body.
• 11. If it is necessary to administer drops to both eyes, repeat the above steps for the second eye.
• 12. Immediately after use, tightly close the bottle.
• 13. At the same time, only one bottle of the medicine should be used.

If the drop does not get into the eye, the patient should try again to administer the drop correctly.

Using more Flucon than recommended

In case of accidental administration of an excessive amount of eye drops, the patient should rinse their eyes with lukewarm water. The patient should not use the medicine until the next scheduled dose.

Missing a dose of Flucon

If a dose of Flucon is missed, the patient should take the next scheduled dose. However, if it is almost time for the next dose, the missed dose should be skipped, and the patient should return to their regular dosing schedule. The patient should nottake a double dose to make up for the missed dose.
If the patient is using other eye drops or ointments, they should wait at least 5 minutes between administrations of the different medicines. Eye ointments should be used last.
If the patient has any further doubts about using this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Flucon can cause side effects, although not everybody gets them.
During treatment with Flucon eye drops, the following side effects have been observed with unknown frequency(the frequency of occurrence could not be determined from the available data):

• increased eye pressure, blurred vision, eye pain, discomfort in the eye (transient burning or stinging after administration of the medicine), foreign body sensation in the eye, eye irritation, eye redness, increased tearing, blurred vision; - taste disturbances.

Description of selected side effects

• Prolonged topical use of corticosteroids in the eyes may result in increased intraocular pressure with optic nerve damage, decreased visual acuity, and visual field disturbances, as well as the formation of posterior subcapsular cataracts and delayed wound healing (see section 2).
• When using combination therapy containing corticosteroids, secondary infections may occur (see section 2).
• In the course of diseases leading to thinning of the cornea or sclera, there is a greater risk of perforation (see section 2).
• In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposition during treatment.

Unless the side effects are severe, the patient can usually continue using the drops. If in doubt, the patient should consult a doctor or pharmacist.
If side effects occur, the patient should inform their doctor or pharmacist. This includes side effects not listed in this leaflet.

Reporting side effects

If side effects occur, including side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al.
Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Flucon

To prevent infections, the bottle should be discarded 28 days after it is first opened.
The date of opening the bottle should be written in the space provided below.
Date of first opening:………………
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not store in the refrigerator.
Do not freeze.
Store the container tightly closed.
The expiration date is the last day of the specified month.

6. Contents of the pack and other information

What Flucon contains

• The active substance of the medicine is fluorometholone 1 mg/ml.
• The other ingredients are: monosodium phosphate monohydrate, disodium phosphate, polysorbate 80, sodium chloride, benzalkonium chloride, disodium edetate, polyvinyl alcohol, hypromellose, hydrochloric acid, and/or sodium hydroxide (to adjust the pH), purified water.

What Flucon looks like and contents of the pack

Flucon is a liquid (suspension, white to light brown) in a 5 ml plastic bottle with a dropper made of low-density polyethylene with a polypropylene cap. The carton contains 1 bottle of 5 ml.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Immedica Pharma AB
Solnavägen 3H
113 63 Stockholm
Sweden

Manufacturer:

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Number of the marketing authorization in Greece, the country of export: 47840/14-10-2008
Number of the parallel import authorization: 71/21

Date of approval of the leaflet: 27.09.2023

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