Fluconazole

Package leaflet: Information for the user

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

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

1. What Flucon is and what it is 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 Flucon is and what it is used for

Flucon is used in the treatment of non-infectious inflammatory eye conditions.
Flucon belongs to a group of medicines called corticosteroids. These act by preventing or reducing inflammation.

2. Important information before using Flucon eye drops

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, smallpox, chickenpox or any other viral eye infection,
• fungal eye infection,
• tuberculous eye infection,
• untreated purulent eye infection.

Warnings and precautions

• Flucon should be used only for instillation into the eye (eyes).
• If the patient uses Flucon eye drops for a long period:
• increased intraocular pressure may occur. The risk of corticosteroid-induced increase in intraocular pressure is higher in children and may occur more rapidly than in adults. Particular caution is advised when using this medicine in children. The risk of corticosteroid-induced ocular hypertension and posterior subcapsular cataract formation is also greater in patients with concomitant diseases (e.g. in patients with diabetes).
• The patient may develop glaucoma with optic nerve damage, decreased visual acuity and visual field defects, as well as development of posterior subcapsular cataract.
• If symptoms worsen or a sudden relapse of the disease occurs, contact a doctor. The patient may be more susceptible to eye infections.
• If an infection occurs, the doctor will prescribe another medicine appropriate for treating that infection.
• Topically applied corticosteroid medicines may delay healing of eye wounds. Concurrent local use of non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of eye healing problems.
• If the patient suffers from conditions leading to thinning of ocular tissues, he or she should consult a doctor or pharmacist before using this medicine.
• If the patient is using other medicines concurrently, he or she should carefully read the section "Flucon with other medicines".
• If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Special caution is required when using fluorometholone in the treatment of
herpes simplex virus infection ( herpes simplex ). Consult a doctor if the condition
worsens or does not improve.
Topical corticosteroid administration may be associated with reduced urinary cortisol excretion and decreased plasma cortisol concentration. Corticosteroids have been associated with reduced growth velocity in children, particularly with high doses and prolonged treatment. This should be discussed with a doctor or pharmacist before starting treatment with Flucon.

Children
The safety of Flucon has not been established in children under 3 years of age; therefore, its use is not recommended in this age group.

Flucon with other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use, including medicines available without a prescription. If the patient is using other eye drops or ointments at the same time, at least a 5-minute interval should be maintained between applications of each medicine. Eye ointments should be applied last.
Concurrent topical use of corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of corneal healing problems. No interaction studies have been conducted.
When using eye drops intended to dilate the pupil (e.g. atropine), which may cause increased intraocular pressure, this effect may be enhanced when Flucon is used concomitantly.
Ocular corticosteroids may increase intraocular pressure, thereby reducing the effectiveness of anti-glaucoma medications.
Some medicines may enhance the effect of Flucon, and therefore the treating physician may decide to carefully monitor the patient taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines
Flucon has no or negligible effect on the ability to drive and operate machinery.
For a short time after administration of Flucon, vision may be blurred. Do not drive or operate machinery until this symptom has resolved.

Flucon contains benzalkonium chloride
The medicine contains 0.5 mg of benzalkonium chloride in every 5 ml of suspension, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly in individuals with dry eye syndrome or corneal disorders (the transparent front layer of the eye). If abnormal eye sensations, stinging or eye pain occur after using the medicine, contact a doctor.

Flucon contains phosphate buffers
Flucon eye drops contain 8.5 mg of monosodium dihydrogen phosphate monohydrate and 12.5 mg of disodium phosphate in every 5 ml of suspension, equivalent to 2.8 mg of phosphates per ml.
In patients with severe damage to the transparent front part of the eye (cornea), phosphates may very rarely cause corneal clouding due to calcium accumulation during treatment.

3. How to use Flucon eye drops

This medicine should always be used exactly as prescribed by your doctor.
If in doubt, consult your doctor or pharmacist.
If the safety collar becomes loose after removing the cap, discard it before using the medicine.

Adolescents and adults (including elderly patients)
The usual dose of Flucon eye drops is one drop into the affected eye or eyes two to four times daily. During the first 24 to 48 hours, your doctor may increase the frequency to one drop every four hours. Your doctor will inform you how long the treatment should continue.

Children
The safety of using Flucon in children under 3 years of age has not been established.
Your doctor will determine the duration of treatment.

If Flucon is used in patients with glaucoma, the treatment duration should be limited to 2 weeks unless prolonged use is medically justified.

Flucon eye drops are intended exclusively for ophthalmic use.

1 2 3 4
Instructions for using 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 with the bottom facing upwards, using your thumb and middle finger (picture 1).
6. Tilt your head backward. Gently pull down the lower eyelid with a clean finger to form a small pocket between the eyelid and the eyeball—this is where the drop should go (picture 2).
7. Bring the dropper tip close to the eye. You may use a mirror to assist.
8. Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. This could contaminate the solution.
9. Gently squeeze the bottom of the inverted bottle to release a single drop of Flucon into the eye (picture 3).
10. After instillation, remove the finger from the lower eyelid. Close the eye and gently press the inner corner of the eye near the nose with a finger for about 2 minutes (picture 4). This helps prevent the medicine from draining into the nasal passages and being absorbed into the systemic circulation.
11. If drops are needed in both eyes, repeat the steps above for the other eye.
12. Immediately after use, tightly replace the cap on the bottle.
13. Only one bottle should be used at a time.

If the drop misses the eye, repeat the procedure to correctly instill the drop.

If you use more Flucon than you should
If too many drops are instilled, rinse the eyes with lukewarm water. Do not use the medicine again until it is time for your next scheduled dose.

If you forget to use Flucon
If you miss a dose of Flucon, apply the next dose as scheduled. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for a missed dose.

If you are using other eye drops or ointments
Leave at least a 5-minute interval between applying different eye medications. Eye ointments should be used last.

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

4. Possible adverse reactions

Like all medicines, Flucon eye drops can cause adverse reactions, although not everyone experiences them.

During the use of Flucon eye drops, the following adverse reactions have been observed with unknown frequency (frequency cannot be estimated from the available data):

• Increased intraocular pressure, blurred vision, eye pain, sensation of ocular discomfort (transient burning or stinging after application), foreign body sensation in the eye, eye irritation, eye redness, excessive tearing, blurred vision;
• Taste disturbances.

Description of selected adverse reactions

• Prolonged local use of corticosteroids administered to the eyes may lead to increased intraocular pressure, resulting in optic nerve damage, decreased visual acuity, visual field defects, development of subcapsular cataract, and delayed wound healing (see section 2).
• When using combination therapy containing corticosteroids, secondary infections may occur (see section 2).
• In diseases leading to thinning of the cornea or sclera, there is an increased risk of perforation (see section 2).
• In patients with severe damage to the transparent anterior part of the eye (cornea), phosphates may very rarely during treatment cause corneal opacification due to calcium deposition.

If adverse reactions are not severe, treatment with the drops can usually be continued. If in doubt, consult a doctor or pharmacist.
If any adverse reactions occur, inform your doctor or pharmacist. This also applies to adverse reactions not listed in this leaflet.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland.
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to increase knowledge about the safety of this medicine.

5. How to store Flucon

To prevent infections, the bottle must be discarded 4 weeks after first opening.
The date of opening the bottle should be recorded in the space provided below.
Date of first opening: ………………
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Do not store in the refrigerator.
Do not freeze.
Keep the container tightly closed.
The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information

What Flucon contains

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

What Flucon looks like and contents of the pack
Flucon is a liquid (suspension, white to light amber) in a 5 ml plastic bottle with a polyethylene dropper and a polypropylene screw cap. The carton box contains 1 bottle with a capacity of 5 ml.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, the country of export:
Immedica Pharma AB
Solnavägen 3H
113 63 Stockholm
Sweden
Manufacturer:
Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou
08320 Barcelona
Spain
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Greece, the country of export: 87337/01-11-2022
Parallel Import Licence number: 71/21