Flarex

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Flarex, 1 mg/ml, eye drops, suspension
Fluorometholone acetonide
Please read the entire leaflet before using the medicine, as it contains important
information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, 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 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,
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 or any other viral eye infection,
• fungal eye infection,
• tuberculous eye infection,
• untreated purulent eye infection.

Corticosteroids should not be used in 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 greater in children and may occur more rapidly than in adults. Particularly when treating children, medical advice should be sought. The risk of corticosteroid-induced ocular hypertension and posterior subcapsular cataract formation is also higher in patients with other diseases (e.g. patients with diabetes).
• The patient may develop glaucoma, characterized by optic nerve damage, reduced visual acuity, visual field defects, and also posterior subcapsular cataract formation.
• If symptoms worsen or a sudden recurrence of the disease occurs, the patient should 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 steroid medicines may delay healing of eye injuries. Concurrent topical use of non-steroidal anti-inflammatory drugs may increase the risk of eye healing problems.
• If the patient suffers from conditions leading to thinning of ocular tissues, he/she should consult a doctor 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 decreased urinary cortisol excretion and reduced plasma cortisol concentration. Corticosteroids have been associated with reduced growth velocity in children, particularly at high doses and with long-term treatment.
• Ocular herpes has occurred in patients who have been treated with systemic or topical corticosteroids for other conditions. Corticosteroid therapy in the treatment of herpes, other than herpes simplex epithelial keratitis (in which it is contraindicated), requires great caution. Regular slit-lamp microscopic examination is necessary.

If the patient experiences blurred vision or other visual disturbances, he/she should contact a doctor.
Before starting treatment with Flarex, discuss this with a doctor or pharmacist.
Children
Use of Flarex eye drops is not recommended in children.
Flarex with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including those available without a prescription.
If the patient is using other eye drops or ointments at the same time, at least 5 minutes should be left between applications of each medicine. Eye ointments should be applied last.
Concurrent topical use of a steroid medicine and a non-steroidal anti-inflammatory medicine may cause problems with 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 when 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 doctor 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 baby, she should consult a doctor or pharmacist before using this medicine.
It is not known whether Flarex may cause fetal harm when administered to a pregnant woman or whether it may adversely affect fertility. Flarex should be given to a pregnant woman only if the physician considers it necessary.
It is not known whether the medicine is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when administering Flarex to a breastfeeding woman.
Driving and using machines
Flarex has no or negligible effect on the ability to drive and use machinery.
For a short time after instillation, vision may be blurred. Do not drive or operate machinery until this symptom has resolved.
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. Contact lenses should be removed before instillation and at least 15 minutes should be waited 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 eye sensations, stinging, or eye pain occur after using the medicine, contact a doctor.
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 front part of the eye (cornea), phosphates may very rarely cause corneal clouding due to calcium deposition during treatment.

3. How to use Flarex

This medicine should always be used exactly as directed by the 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.

Children 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 doctor 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 doctor.
Regular monitoring of intraocular pressure is recommended.
Avoid prematurely discontinuing treatment.
Your doctor will determine how long the treatment should continue.

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

Flarex is 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 hands thoroughly.
3. Shake the bottle well.
4. Unscrew the cap.
5. Hold the bottle with the bottom facing upwards, grasped between 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 dropper tip close to the eye. A mirror may be used to assist.
8. Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. This could contaminate 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 being absorbed systemically.
11. If drops are needed in 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.

Accidental overdose of Flarex
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 the next dose is due shortly, skip the missed dose and resume 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 applying different eye medications. Eye ointments should be used last.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Flarex may cause adverse reactions, although they do not occur in all patients.
The following adverse reactions have been observed during the use of Flarex eye drops:
Uncommon (may affect 1 to 10 out of 1,000 patients):
eye irritation, eye hyperemia, increased intraocular pressure
Rare (may affect 1 to 10 out of 10,000 patients):
eye infection (exacerbation or secondary infection), eye swelling, eye itching, reduced visual acuity,
posterior subcapsular cataract, glaucoma, visual field defect, pupil dilation, ptosis, hypersensitivity, impaired healing
Very rare (may affect 1 to 10 out of 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, lead to corneal clouding 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 hyperemia, excessive tearing, unsharp vision, taste disturbances
If adverse reactions are not severe, treatment with the drops can usually be continued. If in doubt, consult your 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, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 helps to provide more information on the safety of this medicine.

5. How to store Flarex medicine

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

6. Contents of the package and other information

What Flarex contains

• The active substance is fluorometholone acetate 1 mg/ml. 1 ml of suspension contains 1 mg of fluorometholone acetate.
• The other ingredients are: benzalkonium chloride, solution; disodium edetate; monosodium dihydrogen phosphate monohydrate (E 339); 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 (suspension, white to light amber in colour).
The immediate packaging consists of a 5 ml DROPTAINER bottle with a dropper made of LDPE and a cap made of PP with a tamper-evident ring, placed in a cardboard carton.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Bulgaria, 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
Immedica Pharma AB
Solnavägen 3H
SE-113 63 Stockholm
Sweden
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Bulgaria, country of export: 9900078
Parallel Import Licence Number: 75/26