Flarex
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the 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 the medicine, as it contains important information for the patient.
- Keep this leaflet for future reference.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
- If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
Table of contents
- What Flarex is and what it is used for
- Important information before using Flarex
- How to use Flarex
- Possible side effects
- How to store Flarex
- 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
that respond 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, 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 (eyes).
- 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. In particular, when treating children, medical advice should be sought.
The risk of corticosteroid-induced ocular hypertension and cataract formation is also higher in patients with concomitant diseases (e.g. patients with diabetes).
- Glaucoma with optic nerve damage, reduced visual acuity, visual field defects, and posterior subcapsular cataract may develop.
- If symptoms worsen or there is a sudden recurrence of the disease, consult a doctor. The patient may become more susceptible to eye infections.
- If an infection occurs, the doctor will prescribe another medicine appropriate for treating the infection.
- Topically applied corticosteroid medicines may delay healing of eye injuries. Concurrent topical use of non-steroidal anti-inflammatory drugs may increase the risk of impaired eye healing.
- If the patient suffers from diseases causing thinning of ocular tissues, he/she should consult a doctor or pharmacist before using this medicine.
- If the patient is taking other medicines, carefully read section "Flarex and other medicines".
- Local administration of corticosteroids may be associated with decreased urinary cortisol excretion and reduced plasma cortisol concentration. Corticosteroids have been associated with reduced growth rate in children, particularly with high doses and long-term treatment.
- Ocular herpes has occurred in patients previously treated with systemic or topical corticosteroids for other conditions. Corticosteroid therapy in the treatment of herpes infections, other than epithelial keratitis where it is contraindicated, requires great caution. Regular slit-lamp microscopic examination is necessary.
If the patient experiences blurred vision or other visual disturbances, consult a doctor.
Before starting Flarex, discuss this with your doctor or pharmacist.
Children
Use of Flarex eye drops is not recommended in children.
Flarex and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking or has recently taken, including medicines available without a prescription.
If the patient is using other eye drops or ointments at the same time, at least 5 minutes should elapse between administration of each medicine. Eye ointments should be used 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 increased intraocular pressure, this effect may be enhanced when Flarex is used concurrently.
Corticosteroid eye medicines may increase intraocular pressure, thereby reducing the effectiveness of anti-glaucoma medicines.
Some medicines may enhance the effect of Flarex, therefore the treating doctor 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 her 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 adversely affect fertility. Flarex should be given to a pregnant woman only if clearly needed, as determined by a physician.
It is not known 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 breastfeeding woman.
Driving and operating machinery
Flarex has no effect or negligible effect on the ability to drive and operate 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 change their color. 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 patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, consult 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, anterior part of the eye (cornea), phosphates may very rarely cause corneal clouding due to calcium deposits during treatment.
3. How to use Flarex
This medicine should always be used exactly as directed by the physician.
In case of doubt, consult your doctor or pharmacist.
If the safety collar becomes loose after removing the cap, it should be discarded before using the medicine.
Children and adults (including elderly patients)
The usual dose of Flarex is one to two drops instilled 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 their doctor.
Regular monitoring of intraocular pressure is recommended.
Premature discontinuation of treatment should be avoided.
The duration of treatment will be determined by the physician.
Children
The safety and efficacy of Flarex in children have not been established; therefore, its use is not recommended in this age group.
If the medicine is used in patients with glaucoma, the treatment period should be limited to 2 weeks unless prolonged therapy is clinically justified.
Flarex is intended exclusively for ophthalmic use.
Instructions for using eye drop solution
- Prepare the bottle of eye drops and a mirror.
- Wash hands thoroughly.
- Shake the bottle well.
- Unscrew the cap.
- Hold the bottle in hand with the bottom facing upwards, using thumb and middle finger (Figure 1).
- Tilt the head backwards. Gently pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eyeball, into which the drop should be placed (Figure 2).
- Bring the tip of the dropper close to the eye. A mirror may be used to assist.
- Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. This could contaminate the solution and lead to infection.
- Gently squeeze the bottom of the bottle to release a single drop of Flarex (Figure 3).
- After instilling the eye 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 systemic circulation.
- If drops are needed in both eyes, repeat the above steps for the second eye.
- Immediately after use, replace the cap on the bottle.
- Only one bottle should be used at a time. If the drop misses the eye, repeat the procedure to correctly instill the drop.
Use of more than the recommended dose of Flarex
If too many drops have been 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 resume the regular dosing schedule. Do not use a double dose to make up for a missed dose.
If a patient is using other eye drops or ointments simultaneously, at least a 5-minute interval should be maintained between the administration of each product. Eye ointments should be applied last.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like any medicine, Flarex may cause adverse reactions, although they do not occur in everyone.
During the use of Flarex eye drops, the following adverse reactions have been observed:
Not very common (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, 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, front part of the eye (cornea), phosphates may, in very rare cases, lead to corneal clouding during treatment due to calcium accumulation.
Frequency not known (frequency cannot be estimated from the 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 includes 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 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 helps to provide more information on the safety of this medicine.
5. How to store the medicine Flarex
To prevent infections, the bottle should be discarded four weeks after first opening.
The date of first opening should be recorded in the space provided below.
Date of first opening: ……………..
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
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 stated month.
6. Contents of the packaging 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 components 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 pale yellowish).
The immediate packaging consists of a DROPTAINER bottle with a dropper made of LDPE and a cap with a tamper-evident ring made of PP, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
Immedica Pharma AB
Solnavägen 3H, 113 63 Stockholm, Sweden
Manufacturer:
Siegfried El Masnou S.A., Camil Fabra 58, El Masnou, 08320 Barcelona, Spain
S.A. Alcon-Couvreur N.V., Rijksweg 14, 2870 Puurs, Belgium
Immedica Pharma AB, Solnavägen 3H, 113 63 Stockholm, Sweden
Parallel importer:
Delfarma Sp. z o.o.
ul. Świętej Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Świętej Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Bulgaria, the country of export: 9900078
Parallel Import Authorisation Number: 284/25