Fluatón

Patient Information Leaflet

FLUATON 1mg/ml eye drops, suspension

fluorometholone
Please read all of this leaflet carefully before you start 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, 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 FLUATON is and what it is used for

FLUATON contains the active substance 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 inflammations of the anterior part of the eye.

2. What you should 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 the eye;
• if you have acute herpes simplex infection or other acute ulcerative viral diseases of the cornea, except when used concomitantly with specific antiviral chemotherapeutic agents, and in cases of keratoconjunctivitis with ulcerative corneal inflammation even in the initial phase;
• if you have tuberculosis of the eye;
• if you have a fungal infection of the eye;
• if you have a severe acute purulent eye infection, purulent conjunctivitis, or herpes virus-related conjunctivitis, as these may be masked or worsened by corticosteroids;
• if you have a stye (hordeolum);
• if you have a corneal infection caused by the herpes virus, unless otherwise directed by your doctor;
• in children under 2 years of age. Generally contraindicated during pregnancy and breastfeeding (see section "Pregnancy and breastfeeding").

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

• do not use Fluaton continuously for more than one month, as this may cause adverse effects such as glaucoma, optic nerve damage, visual acuity and visual field defects, posterior subcapsular cataract formation, or may promote chronic eye infections.
• prolonged use of steroids may additionally lead to corneal infections; your doctor will consider this possibility in any case of corneal ulcer where a steroid has been or is being used. In case of infection, your doctor will prescribe appropriate therapy.
• in diseases causing thinning of the cornea or sclera, perforation is known to occur due to topical steroids;
• if you wear contact lenses: remove your contact lenses before applying the drops and wait at least 15 minutes before reinserting them (see section “FLUATON in 5 ml bottle contains benzalkonium chloride”).

Contact your doctor if you experience blurred vision or other visual disturbances.
Your doctor will perform frequent check-ups during treatment with FLUATON in the following cases:

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

If you do not notice improvement after two weeks of treatment, consult your doctor.
This medicine must not be injected.
Children
FLUATON must not be used in children under 2 years of age, as safety and efficacy have not been established in children below this age.
Other medicines and FLUATON
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines.
Some medicines may increase the effects of Fluaton, and your doctor may decide to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Concomitant use of topical corticosteroids and topical NSAIDs (non-steroidal anti-inflammatory drugs) may potentially delay wound healing.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant, your doctor will assess whether the benefits to you clearly outweigh the risks to the fetus before prescribing FLUATON.
Breastfeeding
It is not known whether fluorometholone or its metabolites are excreted in human breast milk following topical ocular administration.
Consult your doctor before taking any medicine during breastfeeding.
Driving and using machines
FLUATON does not affect alertness and may therefore be used by patients who need to drive or operate machinery.
However, if you experience transient blurred vision or other visual disturbances, wait until your vision clears before driving or operating 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 very rarely cause corneal opacities due to calcium deposits during treatment.
FLUATON in 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 may be absorbed by soft contact lenses and may alter their color. Remove your 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 most superficial transparent layer of the eye). If you experience an abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use FLUATON

Use this medicine exactly as directed by 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 daily, 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 the single-dose container is intact.

1. Detach the single-dose container from the strip

2. Open by rotating the top part without pulling

Avoid letting the tip of the container come into contact with the eye or any other surface.
If you use more FLUATON than you should
In case of accidental ingestion or overdose of FLUATON, inform your doctor immediately or go to the nearest hospital.
If you forget to use FLUATON
Do not use a double dose to make up for the missed dose.
If you stop using FLUATON
If you have any doubts about using 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 estimated from the available data).

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

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

Prolonged use of FLUATON may cause:

• glaucoma
• optic nerve damage
• visual acuity and visual field defects
• subcapsular cataract formation
• chronicization of eye infections.

In diseases causing thinning of the cornea or sclera, eye perforation may occur (see section 2).
Very rarely, some patients with severe damage to the transparent front part of the eye (cornea) have developed during treatment cloudy spots on the cornea due to calcium deposits.

Reporting of side effects
If you get any side effects, 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 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 above 25°C.
This medicine does not contain preservatives; use it immediately after opening the container.
Discard the single-dose container even if some medicine 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 FLUATON contains
FLUATON in 5 ml bottle

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

FLUATON in single-dose containers

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

Description of FLUATON and contents of the pack
FLUATON in 5 ml bottle
Each pack contains 1 plastic bottle with a dropper and screw cap.
FLUATON in single-dose containers
Each pack contains 20 single-dose units 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 5 ml bottle
Tubilux Pharma S.p.A.
Via Costarica 20/22
Pomezia (Rome)
Italy
FLUATON in single-dose containers
Laboratoire Chauvin
Zone Industrielle Ripotier Haut
07200 Aubenas – France
Patient Information Leaflet: Information for the patient

FLUATON 1mg/g ophthalmic ointment

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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 FLUATON is and what it is used for

FLUATON contains the active substance 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 inflammations of the anterior part of the eye.

2. What you should 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 the eye;
• if you have an acute herpes simplex infection or other viral corneal diseases in the acute ulcerative phase, except when used in combination with specific antiviral chemotherapeutic agents, or in cases of conjunctivitis with ulcerative corneal inflammation even in the early stages;
• if you have tuberculosis of the eye;
• if you have a fungal infection of the eye;
• if you have a severe acute purulent eye infection, purulent conjunctivitis, or herpes virus-related conjunctivitis, as these may be masked or worsened by corticosteroids;
• if you have a stye (hordeolum);
• if you have a corneal infection caused by the herpes virus, unless otherwise directed by your doctor.

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

• do not use Fluaton continuously for longer than one month, as it may cause adverse effects. Contact your doctor if you experience blurred vision or other visual disturbances.

Your doctor will perform frequent check-ups during your treatment with FLUATON if:

• you are being treated for stromal herpes simplex;
• you require prolonged treatment, especially in pediatric patients or in patients with predisposing conditions (e.g. diabetic patients).

If you do not observe any improvement after two weeks of treatment, consult your doctor.
Children
FLUATON must not be used in children under 2 years of age, as safety and efficacy have not been established in children below this age.
Other medicines and FLUATON
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may increase the effects of Fluaton, and your doctor may decide to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Concomitant use of topical corticosteroids and topical NSAIDs (non-steroidal anti-inflammatory drugs) may potentially delay the healing process of wounds.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant, your doctor will assess whether the benefits to you clearly outweigh the risks to the fetus before prescribing FLUATON.
Breastfeeding
It is not known whether fluorometholone or its metabolites are excreted in human milk following topical ocular administration.
Consult your doctor before taking any medicine during breastfeeding.
Driving and using machines
FLUATON does not affect alertness and can therefore be used by patients who need to drive vehicles or operate machinery.
However, if you experience transient blurred vision or other visual disturbances, wait until your vision clears before driving or operating machinery.

3. How to use FLUATON

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 administration once daily, or as prescribed by your doctor.
Apply FLUATON into the conjunctival sac, that is, inside the lower eyelid of the eye.
If you use more FLUATON than you should
In case of accidental ingestion or overdose with FLUATON, inform your doctor immediately or go to the nearest hospital.
If you forget to use FLUATON
Do not use a double dose to make up for the missed dose.
If you stop using FLUATON
If you have any doubts about using 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 (frequency cannot be
determined from the available data).
Stop treatment and consult your doctor if you experience one or more of the
following local effects:

• 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
• visual field defects
• subcapsular cataract formation
• chronicization of eye infections.

In diseases causing thinning of the cornea or sclera, eye perforation may occur (see section 2).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store at room temperature.
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 FLUATON contains

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

Description of the appearance of FLUATON and contents of the pack
Each pack of FLUATON ophthalmic ointment contains one 5 g aluminium tube.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 (Rome)
Italy