Package leaflet: Information for the user

FLUMETOL 0.2% eye drops, suspension

Fluorometholone
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What FLUMETOL is and what it is used for
What you need to know before using FLUMETOL
How to use FLUMETOL
Possible side effects
How to store FLUMETOL
Contents of the pack and other information

1. What FLUMETOL is and what it is used for

FLUMETOL is a ophthalmic suspension containing fluorometholone, an anti-inflammatory corticosteroid, indicated for the treatment of inflammatory conditions of the eye and its adnexa, including conjunctivitis, blepharoconjunctivitis, keratitis and keratoconjunctivitis, episcleritis and scleritis, chalazion, pterygium, dacryocystitis, and post-surgical reactions.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using FLUMETOL

Do not use Flumetol

if you are allergic to fluorometholone or to any of the other ingredients of this medicine (listed in section 6);
if you have high intraocular pressure (ocular hypertension);
if you have acute herpes simplex or most other viral diseases of the cornea (the transparent front part of the eye) in the acute ulcerative phase, unless combined with specific antiviral chemotherapeutic agents;
if you have an eye inflammation called ulcerative conjunctivitis with keratitis, even in the initial stage (positive fluorescein test);
if you have viral corneal inflammations (viral herpetic keratitis); its use is not recommended and may only be allowed under strict supervision by an ophthalmologist;
if you have an eye infection caused by the tuberculosis bacterium;
if you have a fungal infection of the eye (fungal eye infection);
if you have eye infections with evident pus production (such as acute purulent ophthalmia, purulent conjunctivitis, and purulent and herpetic blepharitis), which may be masked or worsened by corticosteroids;
if you have a stye (hordeolum);
if you are pregnant or breastfeeding (see Pregnancy and breastfeeding);
in children under 2 years of age (see Children and adolescents).

Warnings and precautions
Talk to your doctor or pharmacist before using Flumetol or if you have used Flumetol for several days, as frequent monitoring of intraocular pressure (intraocular tonus) may be necessary. Prolonged use of Flumetol may lead to glaucoma, optic nerve damage, visual acuity and visual field defects, posterior subcapsular cataract formation, or may promote the establishment of secondary ocular infections caused by pathogens released from ocular tissue.
In diseases causing thinning of the cornea or sclera, perforation due to local steroid use has been reported.
Fungal infections of the cornea are particularly prone to develop following prolonged steroid application; therefore, this possibility should be considered in any case of corneal ulcer where a steroid has been or is being used.
However, appropriate concomitant therapy should be instituted in case of infections.
Prolonged use may cause adverse effects; continuous use for more than one month is not recommended.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Flumetol is contraindicated in children under 2 years of age, as safety and efficacy in this population have not been established.

Other medicines and Flumetol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use Flumetol during pregnancy unless your doctor considers it absolutely necessary.

Breastfeeding
Do not use Flumetol while breastfeeding.

Effects on the ability to drive vehicles and use machinery
Flumetol does not affect the ability to drive vehicles or operate machinery.

FLUMETOL contains benzalkonium chloride
This medicine contains 0.0035 mg of benzalkonium chloride per drop, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use FLUMETOL

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults and children over 2 years of age.
The recommended dose is 1-2 drops instilled into the conjunctival sac, 2-4 times daily,
according to medical prescription.
Shake well before use.
If you use more Flumetol than you should
If an excessive dose of Flumetol is accidentally ingested or administered, inform your doctor immediately or go to the nearest hospital.
If you forget to use Flumetol
Do not use a double dose to make up for the missed dose.
If you stop using Flumetol
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects during treatment with FLUMETOL,
stop treatment immediately and inform your doctor:

burning sensation,
irritation,
allergic reactions to the components of the product.

Systemic absorption-related side effects of the active substances are unlikely. However, keep in mind, especially during prolonged high-dose treatments, the risk of steroid excess.
This medicine contains 0.28 mg of phosphate buffer per drop, equivalent to 8 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause cloudy corneal spots due to calcium accumulation during treatment.
The presence of benzalkonium chloride may cause eye irritation, particularly if you have dry eye or corneal disorders.
Blurred vision has been reported, frequency unknown.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FLUMETOL

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton after Exp.. The expiry date refers to the last day of that month.
Discard the bottle 30 days after first opening, even if some suspension remains.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Flumetol contains

The active substance is Fluorometholone (1 ml of suspension contains 2 mg of fluorometholone)
The other components are sodium chloride, polyvinyl alcohol, polyoxyethylene sorbitan monooleate, hydroxypropylmethylcellulose, benzalkonium chloride (see section FLUMETOL contains benzalkonium chloride), edetate disodium, monobasic sodium phosphate, dibasic sodium phosphate, water for injections

Description of the appearance of Flumetol and contents of the pack
Flumetol is an eye drop suspension, available in a pack containing 1 bottle with dropper of 10 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
THEA FARMA S.p.A.
Via Tiziano, 32
20145 Milan, Italy

Manufacturer
FARMILA-THEA FARMACEUTICI S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI), Italy