FLUMETOL 0.2% Eye drops, suspension

Зміст інструкції

1. FLUMETOL 0,2% eye drops, suspension
   1. What is FLUMETOL and what is it used for?
   2. What you need to know before using FLUMETOL
   3. How to use FLUMETOL
   4. Possible side effects
   5. How to store FLUMETOL
   6. Contents of the pack and other information
2. FLUMETOL 0,1% Ophthalmic Unguent
   1. WHAT IS FLUMETOL ointment AND WHAT IS IT USED FOR
   2. BEFORE USING FLUMETOL ointment
   3. HOW TO USE FLUMETOL ointment
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FLUMETOL ointment
   6. OTHER INFORMATION

FLUMETOL 0,2% eye drops, suspension

Fluorometolone

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FLUMETOL is and what it is used for
• 2. What you need to know before you use FLUMETOL
• 3. How to use FLUMETOL
• 4. Possible side effects
• 5. How to store FLUMETOL
• 6. Contents of the pack and other information

1. What is FLUMETOL and what is it used for?

FLUMETOL is an eye drop suspension containing fluorometholone, a corticosteroid
anti-inflammatory agent, indicated for the treatment of inflammatory conditions of the eye and its
adnexa, conjunctivitis, blepharoconjunctivitis, keratitis and keratoconjunctivitis, episcleritis and
scleritis, chalazion, pterygium, dacryocystitis and for post-operative 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 any of the other ingredients of this medicine (listed in section 6).
• If you suffer from high eye pressure (intraocular hypertension);
• if you suffer from acute Herpes simplex and most other viral diseases of the cornea (the transparent front part of the eye) in an acute ulcerative stage, unless in association with specific antiviral chemotherapeutic agents.
• if you suffer from an eye inflammation called conjunctivitis with ulcerative keratitis even in the early stages (positive fluorescein test).
• if you suffer from corneal inflammation caused by viruses (viral herpetic keratitis) its use is not recommended, which may only be permitted under the strict supervision of an ophthalmologist;
• if you suffer from an eye infection caused by the tuberculosis bacterium;
• if you suffer from an eye infection caused by fungi (eye mycosis);
• if you suffer from eye infections with evident pus production (such as acute purulent ophthalmia, purulent conjunctivitis and purulent and herpetic blepharitis) which may be masked or aggravated by corticosteroids;
• if you suffer from a stye;
• if you are pregnant or breastfeeding (see Pregnancy and breastfeeding);
• in children under 2 years of age (see Children and adolescentsi).

Warnings and precautions
Consult your doctor or pharmacist before using Flumetol or if you have used Flumetol for
many days because it may be appropriate to proceed with frequent checks of
intraocular pressure. Prolonged use of Flumetol may cause
glaucoma, damage to the optic nerves, defects in visual acuity and visual field, formation of
posterior subcapsular cataract, or help stabilize secondary eye infections from pathogens released from the eye tissue.
In diseases that cause thinning of the cornea or sclera, perforation is known to occur due to topical steroids.
Fungal infections of the cornea are particularly prone to developing in conjunction
with applications of steroids prolonged for a long time; therefore, this
possibility must be considered in every type of corneal ulcer where a steroid has been used or is in use.
However, in case of infections, adequate covering therapy should be instituted.
Prolonged use can lead to inconveniences, continuous application for more than a month is not recommended.

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

Other medicines and Flumetol
Tell 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 or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.

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

Breastfeeding
Do not use Flumetol during breastfeeding.

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

FLUMETOL contains benzalkonium chloride
It may cause eye irritation.
Avoid contact with soft contact lenses.
Remove contact lenses before application and wait at least 15 minutes before
reapplying them.
The discoloring action on soft contact lenses is known.

3. How to use FLUMETOL

Use this medicine following the instructions of your doctor or pharmacist exactly. 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 to be instilled into the conjunctival sac, 2-4 times a day,
as prescribed by your doctor.
Shake vigorously before use.

If you use more FLUMETOL than you should
In case of ingestion/accidental intake of an excessive dose of FLUMETOL, immediately inform your doctor or go to the nearest hospital.

If you forget to use FLUMETOL
Do not use a double dose to make up for a 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

Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili .
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 use this medicine after the expiry date which is stated on the pack after Scad..
The expiry date refers to the last day of that month.
Discard the bottle 30 days after first opening, even if some suspension remains.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Flumetol contains

• The active ingredient is Fluorometolone (1 ml of suspension contains 2 mg of fluorometolone
• The other components are sodium chloride, polyvinyl alcohol, polysorbate monooleate, hydroxypropyl methylcellulose, benzalkonium chloride(see paragraph FLUMETOL containsbenzalkonium chloride), sodium edetate, sodium phosphate monobasic, sodium phosphate dibasic, purified water

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
THEA FARMA S.p.A., Via Giotto, 36 - 20145 Milano

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

FLUMETOL 0,1% Ophthalmic Unguent

Fluorometolone
Read this leaflet carefully before using this medicine.

• 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 personally. Never give it to others. Indeed, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What FLUMETOL unguent is and what it is used for
• 2. Before using FLUMETOL unguent
• 3. How to use FLUMETOL unguent
• 4. Possible side effects
• 5. How to store FLUMETOL unguent
• 6. Further information

1. WHAT IS FLUMETOL ointment AND WHAT IS IT USED FOR

This medicine is a corticosteroid anti-inflammatory.
FLUMETOL ointment is indicated in all inflammatory forms of the anterior segment
of the eye and its appendages, conjunctivitis, blepharoconjunctivitis, keratitis and kerato-
conjunctivitis, episcleritis and scleritis, chalazion, pterygium, dacryocystitis. Post-operative reactions.

2. BEFORE USING FLUMETOL ointment

Do not use FLUMETOL ointment

• if you are allergic (hypersensitive) to the active ingredient or any of the excipients of FLUMETOL ointment
• if you experience a) intraocular hypertension; b) acute herpes simplex and most other corneal viral diseases in the acute ulcerative phase, unless associated with specific chemotherapeutic agents for herpes virus; c) conjunctivitis with ulcerative keratitis even in the early stages (fluorescein test +); d) viral herpetic keratitis (its use is therefore not recommended, which may possibly be allowed under the strict supervision of an ophthalmologist); e) tuberculosis of the eye; f) fungal infections of the eye; g) acute purulent ophthalmia;

h) purulent conjunctivitis and purulent and herpetic blepharitis which may be
masked or aggravated by corticosteroids;
i) hordeolum.
Generally contraindicated in pregnancy and during breastfeeding (see “Pregnancy and
Breastfeeding”).
Contraindicated in children under two years of age.

Take special care with FLUMETOL ointment especially
On the occasion of prolonged treatments, frequent checks of intraocular tone are advisable.
Steroid therapy in the treatment of stromal herpes simplex requires great
care; frequent monitoring with a slit lamp is required.
Prolonged use may cause glaucoma, optic nerve damage, defects in visual acuity and
visual field, posterior subcapsular cataract formation, or help to
stabilize secondary ocular infections from pathogens released from ocular tissue.
In diseases that cause thinning of the cornea or sclera, perforation is known to occur due to topical steroids.
Fungal infections of the cornea are particularly prone to developing in coincidence
with applications of steroids prolonged for a long time; therefore, such
possibility must be considered in any type of corneal ulcer where a steroid has been used or is in use.
However, in case of infections, adequate covering therapy should be established.
The safety and efficacy in children under two years of age has not been demonstrated.
Prolonged use can lead to inconveniences, continuous application for more than a month is not recommended.

Use of FLUMETOL ointment with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including those without a prescription.

Pregnancy and breastfeeding
The safety of intensive or prolonged topical steroid therapies during
pregnancy has not been fully established. In pregnant women and in
early infancy, the product should be administered only when absolutely necessary, under the
direct control of the doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
FLUMETOL ointment does not impair the ability to drive vehicles or operate machinery.

3. HOW TO USE FLUMETOL ointment

Always use FLUMETOL following the doctor's instructions exactly. If you have any doubts, you should
consult your doctor or pharmacist.
Apply one or two times a day in the conjunctival sac, as prescribed by your doctor.

If you use more FLUMETOL ointment than you should
If you use more FLUMETOL ointment than you should, contact your doctor.

If you forget to use FLUMETOL ointment
Do not use a double dose to make up for a missed dose.

If you stop treatment with FLUMETOL ointment
Before stopping treatment, contact your doctor.
If you have any doubts about the use of FLUMETOL ointment, contact your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, FLUMETOL ointment may cause side effects, although not everyone will experience them.
Occasionally, a burning sensation, irritation and hypersensitivity reactions to the product's components may occur locally, requiring discontinuation
of treatment and the adoption of appropriate therapeutic measures.
Systemic absorption of the active ingredients is unlikely to cause side effects.
However, be aware, especially with high-dose, prolonged treatments, of the
risk of steroid excess.
undesirable.
If any of these side effects worsen, or if you notice any other not listed in this leaflet, please inform your doctor or pharmacist.

5. HOW TO STORE FLUMETOL ointment

Do not store at a temperature above 30 °C.
Keep FLUMETOL ointment out of the reach and sight of children.
Do not use FLUMETOL ointment after the expiry date which is reported on the outer label
after Exp.
The expiry date refers to the last day of the month and the product in intact packaging
correctly stored.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

6. OTHER INFORMATION

What FLUMETOL ointment contains
The active ingredient is Fluorometolone
The excipients are: Lanolin-derived alcohols, Petrolatum oil, Purified water, p-hydroxybenzoic acid esters
and Petrolatum

Description of the appearance of FLUMETOL ointment and contents of the pack
Ophthalmic ointment. Tube of 5 g

Marketing authorisation holder and manufacturer
Marketing Authorisation Holder: THEA FARMA S.p.A. – Via Giotto, 36 – 20145 MILANO
Production and Control: FARMILA-THEA FARMACEUTICI S.p.A., Via E. Fermi, 50 – 20019
Settimo Milanese (MI).

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