Flarex

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Flarex, 1 mg/ml, eye drops, suspension
Fluorometholone acetonide
Please read the entire leaflet before using this 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 share it with others. This medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Flarex is and what it is 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 pack and other information

1. What Flarex is and what it is used for

Flarex is indicated for the treatment of symptoms of non-infectious inflammatory eye diseases
responsive to corticosteroids, such as inflammatory conditions of the bulbar and palpebral conjunctiva, eyelids, cornea,
and anterior segment of the eyeball.

2. Important information before using Flarex

When not to use Flarex 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,
• herpes simplex keratitis, vaccinia, varicella (chickenpox), or any other viral eye infection,
• fungal eye infection,
• tuberculosis of the eye,
• untreated purulent eye infection.

Corticosteroids should not be used in cases of infections or injuries limited to the superficial corneal epithelium.
Warnings and precautions

• Flarex should be used only for instillation into the eye(s).
• If the patient uses Flarex eye drops 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. Particular caution is advised when using this medicine in children; medical advice should be sought. The risk of corticosteroid-induced ocular hypertension and posterior subcapsular cataract formation is also

higher in patients suffering from other diseases (e.g., diabetic patients).

• The patient may develop glaucoma, characterized by optic nerve damage, decreased visual acuity, visual field disturbances, and possibly development of posterior subcapsular cataract.
• If symptoms worsen or a sudden relapse of the disease occurs, the patient should contact a physician. The patient may become more susceptible to eye infections.
• If an infection occurs, the physician will prescribe another medicine appropriate for treating that infection.
• Topically applied corticosteroid medicines may delay healing of corneal wounds. Concurrent topical use of non-steroidal anti-inflammatory drugs may increase the risk of impaired corneal healing.
• If the patient suffers from diseases causing thinning of ocular tissues, he/she should consult a physician or pharmacist before using this medicine.
• If the patient is using other medicines concurrently, he/she should carefully read the section “Flarex and other medicines”.
• Topical corticosteroid administration may be associated with reduced urinary cortisol excretion and decreased plasma cortisol concentration. Impaired growth rate in children, particularly with high doses and prolonged treatment, has been observed with corticosteroids.
• Ocular herpes has occurred in patients previously treated with systemic or topical corticosteroids for other conditions. Corticosteroid therapy in the treatment of herpes other than epithelial keratitis (in which it is contraindicated) requires great caution. Periodic slit-lamp microscopic examination is necessary.

If the patient experiences blurred vision or other visual disturbances, he/she should contact a physician.
Before starting treatment with Flarex, the patient should discuss it with a physician or pharmacist.
Children
Use of Flarex eye drops is not recommended in children.
Flarex and other medicines
Inform the physician or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use, including over-the-counter medicines.
If the patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between administrations of each medicine. Eye ointments should be applied last.
Concurrent topical use of corticosteroid and non-steroidal anti-inflammatory medicines may lead to impaired healing of eye injuries.
When using eye drops intended to dilate the pupil (e.g., atropine), which may cause elevated intraocular pressure, this effect may be enhanced if Flarex is used concurrently.
Ophthalmic corticosteroid medicines may increase intraocular pressure, thereby reducing the effectiveness of anti-glaucoma medicines.
Some medicines may enhance the effect of Flarex, and therefore the treating physician may decide to monitor the patient carefully (including certain HIV medications: 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 physician or pharmacist before using this medicine.
It is unknown whether Flarex may cause fetal harm when administered to a pregnant woman or whether it may adversely affect fertility. Flarex should be given to pregnant women only if clearly needed.
It is unknown whether the drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when administering Flarex to a nursing woman.
Driving and using machines
Flarex has no or negligible effect on the ability to drive and operate machinery.
Vision may be blurred for a short time after instillation of Flarex. The patient should not drive or operate machinery until this effect has subsided.
Flarex 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 alter their color. Soft contact lenses should be removed before instillation and not reinserted until at least 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially in patients 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, the patient should contact a physician.
Flarex contains phosphates
The medicine contains 3.5 mg of phosphates in each 5 mL of suspension, equivalent to 0.7 mg phosphates/mL.
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may, very rarely, cause corneal calcification and clouding during treatment due to calcium accumulation.

3. How to use Flarex

This medicine should always be used exactly as directed by the physician.
If in doubt, consult a 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 Flarex is one to two drops into the conjunctival sac of the affected eye or eyes, four times daily. During the first 48 hours, the physician may increase the dose to two drops every two hours. If there is no improvement after two weeks of treatment, the patient should contact the physician.
Regular monitoring of intraocular pressure is recommended.
Avoid prematurely discontinuing treatment.
The physician will determine how long the treatment should continue.

Children
The safety and efficacy of Flarex in children have not been established; therefore, use in this age group is not recommended.
If the medicine is used in patients with glaucoma, treatment should be limited to 2 weeks unless longer treatment is justified.

Flarex is intended exclusively for ophthalmic use.

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 hand with the bottom facing upwards, using the thumb and middle finger (Figure 1).
6. Tilt the head backwards. Pull the lower eyelid downwards with a clean finger to form a "pocket" between the eyelid and the eyeball; the drop should be instilled into this pocket (Figure 2).
7. Bring the tip of the dropper close to the eye. A mirror may be used to assist.
8. Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. This could cause contamination of the drops.
9. Gently squeeze the bottom of the bottle to release a single drop of Flarex (Figure 3).
10. After instilling the drop, remove the finger from the lower eyelid. Close the eye and gently press with a finger at the inner corner of the eye near the nose for 2 minutes (Figure 4). This helps prevent the medicine from entering the systemic circulation.
11. If drops are to be administered to both eyes, repeat the above steps for the second eye.
12. Immediately after use, replace the cap on the bottle.
13. Only one bottle of medicine should be used at a time.

If the drop misses the eye, repeat the procedure to correctly instill the drop.
Overdose of Flarex eye drops
If too many drops are instilled into the eyes, rinse the eyes with lukewarm water.
Do not use the medicine again until the next scheduled dose.

Missed dose of Flarex
If a dose of Flarex is missed, take the next scheduled dose as planned. 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 ointments simultaneously, wait at least 5 minutes between administering different medicines. Eye ointments should be used last.

If there are any doubts concerning the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, Flarex may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed during use of Flarex eye drops:
Uncommon (may affect 1 to 10 in 1,000 patients):
eye irritation, eye hyperaemia, increased intraocular pressure
Rare (may affect 1 to 10 in 10,000 patients):
eye infection (exacerbation or secondary infection), eye swelling, eye itching, decreased visual acuity,
posterior subcapsular cataract, glaucoma, visual field defect, pupil dilation, 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 very rarely cause corneal opacities due to calcium accumulation during treatment.
Frequency not known (frequency cannot be estimated from available data):
increased intraocular pressure, eye pain, eye irritation, eye discomfort, foreign body sensation in the eye, blurred vision, eye hyperaemia, increased lacrimation, unsharp vision, taste disturbances
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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows further information on the safety of this medicine to be collected.

5. How to store Flarex medicine

To prevent infections, the bottle should be discarded four weeks after first opening.
The date of first opening should be recorded in the space indicated below.
Date of first opening: ……………..
Medicines should 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.
Keep the medicine out of sight and reach of children.
Store 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 stated month.

6. Contents of the package and other information

What Flarex contains

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

What Flarex looks like and contents of the pack
Flarex is a liquid (a suspension, white to light amber in colour).
The immediate packaging consists of a white 5 ml bottle with a dropper made of LDPE, with a PP screw cap with tamper-evident ring, placed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in the Czech Republic, 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, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in the Czech Republic, country of export: 64/612/00-C
Parallel Import Licence Number: 414/24