Fluconazole

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• 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 of the leaflet:

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 package 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 medicines work by preventing or reducing inflammation.

2. Important information before using Flucon eye drops

When not to use Flucon

• 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,
• herpes simplex keratitis, vaccinia, varicella (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(s).
• If the patient uses Flucon for a prolonged 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. Special caution is advised when using this medicine in children. The risk of corticosteroid-induced ocular hypertension and posterior subcapsular cataract formation is also higher in patients with concomitant diseases (e.g. diabetic patients).
• glaucoma with optic nerve damage, reduced visual acuity, visual field defects, and formation of posterior subcapsular cataract may develop.
• If symptoms worsen or a sudden recurrence of the disease occurs, contact a doctor. The patient may become more susceptible to eye infections.
• If an infection develops, the doctor will prescribe another medicine appropriate for treating that infection.
• Topically applied corticosteroid medicines may delay healing of eye injuries. Concurrent local use of non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of complications in eye healing.
• If the patient suffers from conditions leading to thinning of ocular tissues, they should consult a doctor or pharmacist before using this medicine.
• If the patient is using other medicines concurrently, they should carefully read the section "Flucon and other medicines".
• If the patient experiences blurred vision or other visual disturbances, they should contact a doctor.

Particular 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 reduced plasma cortisol concentration. Corticosteroids have been observed to reduce growth rate in children, particularly with high doses and prolonged treatment.
Before starting treatment with Flucon, discuss this with a doctor or pharmacist.
Children
The safety of Flucon in children under 3 years of age has not been established; therefore, its use is not recommended in this age group.
Flucon and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use, including those available without prescription.
If the patient is using other eye drops or ointments simultaneously, at least 5 minutes should be left between the administration of each medicine. Eye ointments should be administered last.
Concurrent topical use of corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of corneal healing problems.
No studies on interactions have been conducted.
When using eye drops intended to dilate the pupil (e.g. atropine), which may cause elevated intraocular pressure, this effect may be enhanced when Flucon is used concurrently.
Ophthalmic corticosteroids may increase intraocular pressure, thereby reducing the effectiveness of anti-glaucoma medications.
Some medicines may enhance the effect of Flucon, therefore the treating physician may decide to monitor the patient carefully when these medicines are used (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 resolves.
Flucon contains benzalkonium chloride
The medicine contains 0.5 mg of benzalkonium chloride in each 5 ml of suspension, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after using the medicine, contact a doctor.
Flucon contains phosphate buffers
Flucon contains 8.5 mg of monosodium dihydrogen phosphate monohydrate and 12.5 mg of disodium phosphate in each 5 ml of suspension, equivalent to 2.8 mg of phosphates/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 the doctor.
If in doubt, consult a doctor or pharmacist.
If the tamper-evident collar becomes loose after removing the cap, discard it before using the medicine.

Adolescents and adults (including elderly patients)
The usual dose of Flucon is one drop into the affected eye or eyes, two to four times daily. During the first 24 to 48 hours, the doctor may increase the frequency to one drop every 4 hours. The doctor will determine how long the treatment should continue.

Children
The safety of Flucon has not been established in children under 3 years of age.
The doctor will decide how long the treatment should last.
If Flucon is used in patients with glaucoma, treatment should be limited to 2 weeks unless a longer duration is clinically justified.

Flucon is intended exclusively for ophthalmic use (for use in the eyes only).

Instructions for using eye drops

1. Prepare the bottle of eye drops and a mirror.
2. Wash 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 (Figure 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 be placed (Figure 2).
7. Bring the dropper tip close to the eye. Use a mirror if needed.
8. Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. This could contaminate the eye drops.
9. Gently squeeze the bottom of the inverted bottle to release a single drop of Flucon into the eye (Figure 3).
10. After instilling the drop, remove the finger from the lower eyelid. Close the eye and gently press with a finger on the inner corner of the eye near the nose for 2 minutes (Figure 4). This helps prevent the medicine from draining into the rest of the body.
11. If drops are needed in both eyes, repeat the above steps for the second 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.

Accidental overdose of Flucon eye drops
If too many drops are instilled, rinse the eyes with lukewarm water.
Do not use the medicine again until the next scheduled dose.

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

If the patient is using other eye drops or eye ointments at the same time, wait at least 5 minutes 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 effects

Like all medicines, Flucon may cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed during the use of Flucon with unknown frequency (the frequency cannot be estimated from the available data):

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

Description of selected adverse effects

• Prolonged local use of corticosteroids administered to the eyes may lead to increased intraocular pressure with optic nerve damage, decreased visual acuity and visual field disturbances, as well as posterior subcapsular cataract formation and delayed wound healing (see section 2).

• When combination therapy including corticosteroids is used, 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 lead during treatment to corneal opacities due to calcium deposition.

Unless adverse effects are severe, treatment with the eye drops can usually be continued. If in doubt, consult a doctor or pharmacist.
If any adverse effects occur, inform your doctor or pharmacist. This also applies to adverse effects not listed in this leaflet.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Flucon

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

6. Contents of the package 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 (a white to pale yellowish suspension) in a 5 ml bottle made of low-density polyethylene with a polypropylene cap. The carton pack contains 1 bottle with a capacity of 5 ml.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Greece, country of export:
Immedica Pharma AB, Solnavägen 3H, SE-113 63 Stockholm, Sweden
Manufacturer:
Siegfried El Masnou, S.A., Camil Fabra 58, El Masnou, 08320 Barcelona, Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Parallel Importer:
InPharm Sp. z o.o., Strumykowa Street 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska Street 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Greece, country of export: 87337/01-11-2022
47840/14-10-2008
Parallel Import Licence Number: 229/15