FLUATON 1 mg /Ml Eye Drops, Suspension

Зміст інструкції

1. FLUATON 1mg/ml eye drops, suspension
   1. What is FLUATON and what is it used for
   2. What you need to know before you use FLUATON
   3. How to use FLUATON
   4. Possible side effects
   5. How to store FLUATON
   6. Contents of the pack and other information
2. FLUATON 1mg/g ophthalmic ointment
   1. What is FLUATON and what is it used for
   2. What you need to know before using FLUATON
   3. How to use FLUATON
   4. Possible side effects
   5. How to store FLUATON
   6. Contents of the pack and other information

FLUATON 1mg/ml 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is FLUATON and what is it used for

FLUATON contains the active ingredient fluorometholone. Fluorometholone is a substance that
belongs to a group of medicines known as corticosteroids and has significant local
anti-inflammatory activity.
FLUATON is indicated for the treatment of acute and subacute inflammation of the anterior
part of the eye.

2. What you need to know before you use FLUATON

Do not use FLUATON

• if you are allergic to fluorometholone or to any of the other ingredients of this medicine (listed in section 6);
• if you have high pressure inside your eye;
• if you have an acute herpes simplex infection or other viral diseases of the cornea in an acute ulcerative stage, except when used together with specific antiviral chemotherapeutic agents and in conjunctivitis with corneal inflammation in the initial ulcerative stage;
• if you suffer from tuberculosis of the eye;
• if you have a fungal infection of the eye;
• if you suffer from a severe acute purulent eye infection, or purulent conjunctivitis and due to the herpes virus, because they can be masked or aggravated by corticosteroids;
• if you have a stye;
• if you have a corneal infection caused by the herpes virus, unless otherwise advised by your doctor;
• in children under 2 years of age. Generally contraindicated in pregnancy and breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before using FLUATON.
Take special care during treatment with FLUATON:

• do not apply Fluaton continuously for more than one month, as it may cause inconveniences such as glaucoma, damage to the optic nerves, defects in visual acuity and visual field, formation of posterior subcapsular cataract, or may promote the chronicity of eye infections.
• with prolonged use of steroids, corneal infections can also develop; the doctor will consider this possibility in any type of corneal ulcer where a steroid has been used or is being used. In case of infections, the doctor will prescribe adequate therapy.
• in diseases that cause thinning of the cornea or sclera, perforation is known to occur due to topical steroids;
• if you wear contact lenses: remove the contact lenses before application and wait at least 15 minutes before re-applying them (see section “FLUATON in a 5 ml bottle contains benzalkonium chloride”).

Contact your doctor if you experience blurred vision or other visual disturbances.
The doctor will have you undergo frequent checks during treatment with FLUATON in case of:

• treatment of stromal herpes simplex;
• prolonged treatments over time, especially in pediatric patients and in predisposed patients (e.g. diabetic patients).

If you do not see any improvement after two weeks of treatment, consult your doctor.
The medicine should not be injected.

Children
FLUATON should not be used in children under 2 years of age because the
safety and efficacy have not been demonstrated in children under this age.

Other medicines and FLUATON
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Some medicines can increase the effects of Fluaton and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment
of HIV: ritonavir, cobicistat).
The concomitant use of topical corticosteroids and topical NSAIDs (non-steroidal anti-inflammatory drugs)
may potentially slow down the wound healing process.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
If you are pregnant, the doctor will assess whether the benefits for you clearly outweigh the risks to the fetus before
prescribing FLUATON.

Breastfeeding
It is not known whether fluorometholone or its metabolites are excreted in breast milk after
topical ocular administration.
Ask your doctor for advice before taking any medicine while breastfeeding.

Driving and using machines
FLUATON does not alter the state of alertness and can therefore be used even in patients who have to
drive vehicles or operate machinery.
If you experience transient blurred vision or other visual disturbances, wait
until your vision returns to normal before driving vehicles or using machinery.

FLUATON contains phosphate buffer
This medicine contains 0.486 g of phosphate buffer in 100 ml of suspension.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may
cause, in very rare cases, opaque spots on the cornea due to calcium deposition during
treatment.

FLUATON in a 5 ml bottle contains benzalkonium chloride
This medicine in the 5 ml bottle contains 0.0046 g of benzalkonium chloride in 100 ml of
suspension.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change
in their color. Remove the contact lenses before using this medicine and wait 15 minutes before
re-applying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal
sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use FLUATON

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
Shake well before use.
The recommended dose is 2 drops 2 to 4 times a day, or as prescribed by your doctor,
administered drop by drop into the eye.

How to use FLUATON in single-dose containers
Before use, make sure that the single-dose container is intact.

• 1. Detach the single-dose container from the strip

• 2. Open by twisting the top without pulling

Avoid contact of the container end with the eye or any other surface.

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

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

If you stop using FLUATON
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.
Cases of blurred vision have been reported with an unknown frequency (the frequency cannot be
defined based on the available data).

Stop treatment and consult your doctor if you experience one or more of the
following effects locally:

• burning sensation
• irritation
• increased intraocular pressure
• eye pain
• allergic reactions to the components of this medicine.

Prolonged use of FLUATON may cause:

• glaucoma
• damage to the optic nerves
• defects in visual acuity and visual field
• formation of subcapsular cataract
• chronic eye infections.

In diseases that cause thinning of the cornea or sclera, eye perforation is known to occur (see section 2).
In very rare cases, some patients with severe damage to the transparent front part of the eye (cornea)
have developed cloudy spots on the cornea during treatment due to calcium deposits.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://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 FLUATON

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 Exp. The expiry date refers to the last day of that month.
FLUATON in 5 ml bottle
This medicine does not require any special storage conditions.
Use the medicine within 28 days of first opening the container.
FLUATON in single-dose containers
Do not store at a temperature above 25°C.
The medicine does not contain preservatives, use it immediately after opening the container. Throw away the single-dose container even if it still contains some medicine.
Do not dispose of any medicine in wastewater 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 FLUATON contains
FLUATON in a 5 ml bottle

• The active ingredient is fluorometholone. 100 ml of FLUATON contains 0.1 g of fluorometholone.
• The other ingredients are polyvinyl alcohol, benzalkonium chloride, disodium edetate, sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, purified water.

FLUATON in single-dose containers

• The active ingredient is fluorometholone. 100 ml of FLUATON contains 0.1 g of fluorometholone.
• The other ingredients are polyvinyl alcohol, disodium edetate, sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, purified water.

Description of the appearance of FLUATON and contents of the pack
FLUATON in a 5 ml bottle
Each pack contains 1 plastic bottle equipped with a dropper and a screw-cap.
FLUATON in single-dose containers
Each pack contains 20 single-dose containers of 0.4 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bausch & Lomb - IOM S.p.A.
Viale Martesana, 12
20090 Vimodrone (MI)
Italy
Manufacturer

FLUATON in a 5 ml bottle
Tubilux Pharma S.p.A.
Via Costarica 20/22
Pomezia (Roma)
Italy

FLUATON in single-dose containers
Laboratoire Chauvin
Zone Industrielle Ripotier Haut
07200 Aubenas – France

FLUATON 1mg/g ophthalmic ointment

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

1. What is FLUATON and what is it used for

FLUATON contains the active ingredient fluorometholone. Fluorometholone is a substance that
belongs to a group of medicines known as corticosteroids and has significant local
anti-inflammatory activity.
FLUATON is indicated for the treatment of acute and subacute inflammation of the anterior
part of the eye.

2. What you need to know before using FLUATON

Do not use FLUATON

• if you are allergic to fluorometholone or to any of the other ingredients of this medicine (listed in section 6);
• if you have high pressure inside your eye;
• if you have an acute herpes simplex infection or other acute viral diseases of the cornea in an ulcerative stage, except when used together with specific antiviral chemotherapeutic agents for the herpes virus and in conjunctivitis with corneal inflammation in an ulcerative stage even in the early stages;
• if you suffer from tuberculosis of the eye;
• if you have a fungal infection of the eye;
• if you suffer from a severe acute purulent infection of the eye, purulent conjunctivitis and due to the herpes virus, because they can be masked or aggravated by corticosteroids;
• if you have a stye;
• if you have a corneal infection due to the herpes virus, unless otherwise advised by your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before using FLUATON.
Pay particular attention during treatment with FLUATON:

• do not apply Fluaton continuously for more than one month, as this may cause inconvenience. Contact your doctor if you experience blurred vision or other visual disturbances.

The doctor will have you undergo frequent checks during treatment with FLUATON in case of:

• treatment of stromal herpes simplex;
• prolonged treatments over time, especially in pediatric patients and patients predisposed to it (e.g. diabetic patients).

If you do not see improvement after two weeks of treatment, consult your doctor.

Children
FLUATON should not be used in children under 2 years of age as the
safety and efficacy have not been demonstrated in children under this age.

Other medicines and FLUATON
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Some medicines can increase the effects of Fluaton and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment
of HIV: ritonavir, cobicistat).
The concomitant use of topical corticosteroids and topical NSAIDs (non-steroidal anti-inflammatory drugs)
may potentially slow down the wound healing process.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
If you are pregnant, your doctor will assess whether the benefits for you clearly outweigh the risks to the fetus before
prescribing FLUATON.

Breastfeeding
It is not known whether fluorometholone or its metabolites are excreted in breast milk after
topical ocular administration.
Ask your doctor for advice before taking any medicine while breastfeeding.

Driving and using machines
FLUATON does not alter the state of alertness and can therefore also be used by patients who need
to drive vehicles or operate machinery.
If you experience transient blurred vision or other visual disturbances, wait
until your vision returns to normal before driving vehicles or using machinery.

3. How to use FLUATON

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
The recommended dose is 1 administration once a day or as prescribed by your doctor.
Apply FLUATON into the conjunctival sac, i.e. inside the lower eyelid of the eye.

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

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

If you stop the treatment with FLUATON
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.
Cases of blurred vision have been reported with an unknown frequency (the frequency cannot be
defined based on available data).

Stop treatment and consult your doctor if you experience one or more of the
following effects locally:

• burning sensation
• irritation
• increased intraocular pressure
• eye pain
• allergic reactions to the components of this medicine.

Prolonged use of FLUATON may cause:

• glaucoma
• damage to the optic nerves
• impaired visual acuity and visual field defects
• formation of subcapsular cataract
• chronic eye infections.

In diseases that cause thinning of the cornea or sclera, eye perforation is known to occur (see section 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://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 FLUATON

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 Exp. The expiry date refers to the last day of that month.
Store at room temperature.
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 FLUATON contains

• The active ingredient is fluorometholone. 100 g of FLUATON contain 0.1 g of fluorometholone.
• The other ingredients are chlorobutanol, liquid paraffin, lanolin, white petrolatum.

Description of the appearance of FLUATON and contents of the pack
Each pack of FLUATON ophthalmic ointment contains a 5 g aluminium tube.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Bausch & Lomb - IOM S.p.A.
Viale Martesana, 12
20090 Vimodrone (MI)
Italy
Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22
00040 Pomezia (Roma)
Italy