Flarex

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Flarex, 1 mg/ml, eye drops, suspension

Fluorometholone acetate

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Flarex and what is it used for

Flarex is intended for the treatment of symptomsof non-infectious inflammatory eye diseases that respond to corticosteroids, such as conjunctival and eyelid inflammation, corneal and anterior segment inflammation.

2. Important information before using Flarex

When not to use Flarex eye drops

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

Corticosteroids should not be used in the presence of infections or injuries limited to the superficial corneal epithelium.

Warnings and precautions

• Flarex should be used exclusively for eye drops (eyes).
• If the patient uses Flarex eye drops for a long period:
• The patient may experience increased 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, it is recommended to consult a doctor for advice. The risk of corticosteroid-induced glaucoma and cataract development is also

higher in patients suffering from 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.
• If symptoms worsen or an acute relapse occurs, the patient should contact their 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 steroid medicines used in the eyes may delay the healing of eye injuries. Concurrent topical use of non-steroidal anti-inflammatory medicines may cause a risk of eye healing problems.
• If the patient suffers from diseases leading to thinning of 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 "Flarex and other medicines".
• Topical corticosteroid administration may be associated with decreased cortisol secretion in urine as well as decreased cortisol levels in serum. An association between corticosteroids and reduced growth rate in children has been observed, particularly at high doses and with prolonged treatment.
• In patients who have been treated with systemic or topical corticosteroids for other diseases, ocular herpes has occurred. The use of corticosteroid therapy in the treatment of herpes, other than herpetic epithelial keratitis, in which it is contraindicated, requires great caution. Periodic microscopic examination with a slit lamp is necessary.

If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
Before starting to use Flarex, the patient should discuss it with their doctor or pharmacist.

Children

It is not recommended to use Flarex eye drops in children.

Flarex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently using or have recently used, as well as medicines they plan to use, including over-the-counter medicines.
If the patient is using other eye drops or ointments, they should keep a 5-minute interval between administrations of consecutive medicines. Eye ointments should be used last.
Concurrent topical use of a steroid medicine and a non-steroidal anti-inflammatory medicine may cause a risk of eye healing problems.
When using eye drops intended to dilate the pupil (e.g., atropine), which can cause increased intraocular pressure, this effect may be enhanced when Flarex is used at the same time.
Ocular corticosteroids may cause increased intraocular pressure, reducing the effectiveness of anti-glaucoma medicines.
Some medicines may enhance the effect of Flarex, and therefore the doctor may decide to carefully monitor the patient's condition when taking these medicines (including some medicines used to treat HIV: 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 their doctor or pharmacist before using this medicine.
It is not known whether Flarex can cause fetal harm when administered to a pregnant woman, or whether it can affect reproductive capacity. Flarex should be administered to a pregnant woman only if the doctor considers it necessary.
It is not known whether the medicine is excreted in human milk. Since many medicines are excreted in human milk, caution should be exercised when administering Flarex to a breastfeeding woman.

Driving and using machines

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

Flarex 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 in the eye, stinging, or eye pain occur after using the medicine, the patient should contact their doctor.

Flarex contains phosphates

The medicine contains 3.5 mg of phosphates in every 5 milliliters of suspension, which corresponds to 0.7 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 Flarex

This medicine should always be used as directed by the doctor.
In case of doubts, the patient should consult their doctor or pharmacist.
If the protective cap loosens after removing the cap, it should be discarded before using the medicine.

Adolescents and adults (including elderly patients)

The usual dose of Flarex is one to two drops of the medicine into the conjunctival sac of the affected eye or eyes, four times a day. During the first 48 hours, the doctor may increase the dose to two drops every 2 hours. If no improvement occurs after two weeks of using the medicine, the patient should contact their doctor.
Regular monitoring of intraocular pressure is recommended.
The patient should avoid premature discontinuation of treatment.
The doctor will determine how long to use the medicine.

Children

The safety and efficacy of Flarex in children have not been established, so it is not recommended to use it in this age group.
If the medicine is used in patients with glaucoma, the treatment period should be limited to 2 weeks, unless longer treatment is justified.
Flarex is intended exclusivelyfor administration into the eyes.

Method of using 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 direct it upwards with the bottom, holding it with your thumb and middle finger (Figure 1).
• 6. Tilt your head back. 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 of the drops.

• 9. Gently squeeze the bottom of the bottle to release a single drop of Flarex (Figure 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 (Figure 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 using the medicine, screw the bottle cap back on.
• 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 repeat the attempt to administer the drop correctly.

Using a higher dose of Flarex 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 Flarex

If a dose of Flarex is missed, the patient should take the next scheduled dose. However, if there is not much time left until the next dose, the missed dose should be skipped and the patient should return to their normal 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 keep a 5-minute interval between administrations of consecutive medicines. Eye ointments should be used last.
In case of any doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Flarex can cause side effects, although not everybody gets them.
During the use of Flarex eye drops, the following side effects have been observed:
Uncommon(may affect 1 to 10 in 1000 patients):
eye irritation, eye redness, increased intraocular pressure
Rare(may affect 1 to 10 in 10,000 patients):
eye infection (worsening or secondary infection), eye swelling, eye itching, decreased visual acuity, posterior subcapsular cataract, glaucoma, visual field defect, pupil dilation, eyelid ptosis, hypersensitivity, impaired healing
Very rare(may affect 1 to 10 in 100,000 patients): corneal perforation
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.
Frequency not known(frequency cannot be estimated from the available data):
increased intraocular pressure, eye pain, eye irritation, discomfort in the eye, foreign body sensation in the eye, blurred vision, eye redness, increased tearing, blurred vision, visual disturbances
Unless the side effects are severe, the patient can usually continue using the drops. In case of doubts, the patient should consult their doctor or pharmacist.
If any side effects occur, the patient should inform their doctor or pharmacist. This includes any side effects not listed in this leaflet.

Reporting side effects

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

5. How to store Flarex

To prevent infections, the bottle should be discarded 4 weeks 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 containers. 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.
Store in a temperature below 25°C.
Do not use Flarex after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Flarex contains

• The active substance of Flarex is fluorometholone acetate. 1 ml of eye drops, suspension contains 1 mg of fluorometholone acetate.
• The other ingredients are: benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate monohydrate, tyloxapol, sodium chloride, hydroxyethylcellulose, hydrochloric acid and/or sodium hydroxide (to adjust the pH), purified water.

What Flarex looks like and contents of the pack

Flarex is a liquid (suspension, white to light amber).
The immediate packaging consists of a 5 ml white bottle with a dropper made of LDPE, a cap with a tamper-evident ring made of PP, placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Immedica Pharma AB
Solnavägen 3H, 113 63 Stockholm, Sweden

Manufacturer:

S.A. Alcon-Couvreur N.V.
Rijksweg 14, 2870 Puurs-Sint-Amands, Belgium
Immedica Pharma AB
Solnavägen 3H, 113 63 Stockholm, Sweden

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 64/612/00-C

Parallel import authorization number: 414/24

Date of leaflet approval: 21.11.2024

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