Flucon

Package Leaflet: Information for the Patient

Flucon, 1 mg/ml, Eye Drops, Suspension

Fluorometholone

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do not Pass it on to Others. The Medication may Harm them, even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, Including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 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. Package Contents 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 MedicationsCalled Corticosteroids. Their Action Involves Preventing or Reducing Inflammation.

2. Important Information Before Using Flucon

When Not to Use Flucon Eye Drops

• If the Patient is Allergic to the Active Substance or any of the Other Ingredients of this Medication (Listed in Section 6),
• If the Patient has:
• Untreated Acute Bacterial Eye Infection,
• Herpetic Keratitis, Eczema Herpeticum, Chickenpox, or any other Viral Eye Infection,
• Fungal Eye Infection,
• Tuberculous Eye Infection,
• Untreated Purulent Eye Infection.

Warnings and Precautions

• Flucon Should be Used Exclusively for Eye Drops (Eyes).
• If the Patient Uses Flucon Eye Drops for a Long Period:
• The Patient may Experience Increased Eye Pressure. The Risk of Corticosteroid-Induced Increased Eye Pressure is Greater in Children and may Occur Faster than in Adults. Especially when Using the Medication in Children, Consult a Doctor for Advice. The Risk of Corticosteroid-Induced Increased Eye Pressure and Cataract Formation is also Greater in Patients with Other Diseases (e.g., Patients with Diabetes).
• The Patient may Develop Glaucoma with Damage to the Optic Nerve, Impaired Vision, and Visual Field Disturbances, as well as Posterior Subcapsular Cataract.
• If Symptoms Worsen or there is a Sudden Relapse of the Disease, Consult a Doctor. The Patient may be More Susceptible to Eye Infections.
• If an Infection Occurs, the Doctor will Prescribe another Medication to Treat the Infection.
• Topical Steroid Medications for the Eyes 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 Leading to Thinning of the Eye Tissues, Consult a Doctor or Pharmacist Before Using this Medication.
• If the Patient is Using Other Medications, Read the Section "Flucon and Other Medications" Carefully.
• If the Patient Experiences Blurred Vision or other Vision Disturbances, Consult a Doctor.

Special Precautions for the Use of Fluorometholone in the Treatment of Infection

with Herpes Simplex Virus( Herpes Simplex). Consult a Doctor for Advice if the Patient's Condition has Worsened or has not Improved.
Topical Administration of Corticosteroids may be Associated with a Decrease in Cortisol Excretion in Urine as well as a Decrease in Cortisol Concentration in Serum. An Association between Corticosteroids and a Decrease in the Growth Rate in Children has been Observed, Especially at High Doses and with Prolonged Treatment.
Before Starting 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 Medications

Inform the Doctor or Pharmacist about all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications the Patient Plans to Take, including those Available Without a Prescription.
If the Patient is Using Other Eye Drops or Ointments, Wait at Least 5 Minutes Between Administrations of the Next Medications. Eye Ointments should be Used Last.
Concurrent Topical Use of Steroids 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 that are Intended to Dilate the Pupil (e.g., Atropine), which can Cause Increased Intraocular Pressure, this Effect may be Enhanced when Flucon is Used Concurrently.
Eye Corticosteroids may Cause Increased Intraocular Pressure, Reducing the Effectiveness of Glaucoma Medications.
Some Medications may Enhance the Effect of Flucon, and therefore the Doctor may Decide to Monitor the Patient's Condition Closely when Taking these Medications (including some HIV Medications: Ritonavir, Cobicistat).

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant or are Planning to have a Child, Consult a Doctor or Pharmacist Before Using this Medication.

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. Do not Drive or Operate Machines until this Symptom has Resolved .

Flucon Contains Benzalkonium Chloride

The Medication 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. Remove Contact Lenses Before Administering the Drops and Wait at Least 15 Minutes Before Reinserting them.
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 in the Eye, Stinging, or Eye Pain Occur After Using the Medication, Consult a Doctor.

Flucon Contains Phosphate Buffers

Flucon Eye Drops Contain 8.5 mg of Sodium Dihydrogen 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, Front Part of the Eye (Cornea), Phosphates may Rarely Cause Corneal Opacification due to Calcium Deposition during Treatment.

3. How to Use Flucon

This Medication Should Always be Used in Accordance with the Doctor's Recommendations.
In Case of Doubts, Consult a Doctor or Pharmacist.
If the Protective Cap has Loosened After Removing the Seal, Discard it Before Using the Medication.
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 Flucon in Children Under 3 Years of Age has not been Established.
The Doctor will Determine how Long to Use the Medication.
If the Medication is Used in Patients with Glaucoma, the Treatment Period should be Limited to 2 Weeks, unless Longer Treatment is Justified.
Flucon is Intended Exclusivelyfor Administration into the Eyes.

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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 Tilt it Upside Down, Holding it with your Thumb and Middle Finger (Figure 1).
• 6. Tilt your Head Backwards. Pull the Lower Eyelid Down with a Clean Finger to Form a "Pocket" between the Eyelid and the Eye; the Drop should Fall into it (Figure 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.
• 9. Gently Press the Bottom of the Inverted Bottle to Release a Single Drop of Flucon (Figure 3).
• 10. After Administering the Eye Drops, Remove the Finger that was Holding the Lower Eyelid. Close your Eye and Gently Press the Corner of your Eye near the Nose for 2 Minutes (Figure 4). This will Help Prevent the Medication from Entering the Rest of the Body.
• 11. If it is Necessary to Administer Drops to both Eyes, Repeat the Above Steps for the Second Eye.
• 12. Immediately After Use, Tighten the Bottle Cap.
• 13. Use one Bottle of Medication at a Time.

If a Drop Misses the Eye, Repeat the Attempt to Administer the Drop Correctly.

Using More than the Recommended Dose of Flucon

In Case of Accidental Administration of an Excessive Amount of Eye Drops, Rinse the Eyes with Lukewarm Water.
Do not Use the Medication until the Next Scheduled Dose.

Missing a Dose of Flucon

If a Dose of Flucon is Missed, Take the Next Scheduled Dose. However, if there is not Much Time Left before the Next Dose, Skip the Missed Dose and Return to the Normal Administration Schedule. Do notTake a Double Dose to Make up for the Missed Dose.
If the Patient is Using Other Eye Drops or Ointments, Wait at Least 5 Minutes Between Administrations of the Next Medications. Eye Ointments should be Used Last.
In Case of Further Doubts about Using this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, 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), Foreign Body Sensation in the Eye, Eye Irritation, Redness of the Eye, Increased Tear Production, Blurred Vision;
• Taste Disturbances.

Description of Selected Side Effects

• Prolonged Topical Use of Corticosteroids for the Eyes may Result in Increased Intraocular Pressure with Damage to the Optic Nerve, Reduced Vision, and Visual Field Disturbances, as well as the Formation of Posterior Subcapsular Cataract

and Delayed Healing of Eye Wounds (see Section 2).

• In the Case of 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, Front Part of the Eye (Cornea), Phosphates may Rarely Cause Corneal Opacification due to Calcium Deposition during Treatment.

Unless the Side Effects are Severe, the Eye Drops can Usually be Continued.
In Case of Doubts, Consult a Doctor or Pharmacist.
If any Side Effects Occur, Inform a Doctor or Pharmacist. This includes any Side Effects not Listed in this Package Leaflet.

Reporting Side Effects

If any Side Effects Occur, including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side Effects can also be Reported to the Marketing Authorization Holder.
Reporting Side Effects will Help to Gather more Information on the Safety of this Medication.

5. How to Store Flucon

To Prevent Infections, the Bottle Should be Discarded 4 Weeks After First Opening. The Date of First Opening should be Written in the Space Provided Below.
Date of First Opening:………………
Medications should not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.
Keep the Medication out of Sight and Reach of Children.
Store in a Temperature below 25°C.
Do not Store in the Refrigerator.
Do not Freeze.
Store the Container Tightly Closed.
Do not Use Flucon after the Expiration Date Stated on the Label and Carton after "EXP".
The Expiration Date refers to the Last Day of the Specified Month.
The Batch Number on the Packaging is Marked as "Lot".

6. Package Contents and Other Information

What Flucon Contains

• The Active Substance of the Medication is Fluorometholone 1 mg/ml.
• Other Ingredients are: Sodium Dihydrogen Phosphate Monohydrate, Disodium Hydrogen Phosphate Anhydrous, Polysorbate 80, Sodium Chloride, Benzalkonium Chloride (Solution), Disodium Edetate, Polyvinyl Alcohol, Hypromellose (3550 mPa.s), Hydrochloric Acid, and/or Sodium Hydroxide to Adjust the pH, Purified Water.

What Flucon Looks Like and Contents of the Package

Flucon is a Liquid (Suspension, White to Light Amber) in a 5 ml Plastic Bottle (DROPTAINER Type) with a Protected Cap. The Cardboard Box Contains 1 Bottle of 5 ml.

Marketing Authorization Holder

Immedica Pharma AB
Solnavägen 3H
SE-113 63 Stockholm
Sweden

Manufacturer

Siegfried El Masnou S.A.
Camil Fabra 58
El Masnou
08320 Barcelona
Spain

Date of the Last Update of the Package Leaflet: