Exocin

Package leaflet: Information for the patient

EXOCIN 3 mg/ml eye drops, solution

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

1. What EXOCIN is and what it is used for

EXOCIN contains ofloxacin, which belongs to a group of medicines called fluoroquinolones.
Contact your doctor if you do not feel better or if you feel worse after 10 days.
EXOCIN 3 mg/ml eye drops are used to treat external eye infections caused by germs sensitive to ofloxacin, leading to inflammation of the front covering of the eye (conjunctivitis), or inflammation of the eyelid (blepharitis), or simultaneous inflammation of the front covering of the eye and the eyelid (blepharoconjunctivitis), or simultaneous inflammation of the cornea and the front covering of the eye (keratoconjunctivitis), inflammation of the tear sac (dacryocystitis), inflammation of the group of sebaceous glands located in the eyelid (meibomitis), or inflammation of the cornea (keratitis). EXOCIN is also indicated for the treatment of ulcers on the surface of the eye caused by infections and to prevent infections following eye surgery.

2. What you should know before using EXOCIN

Do not use EXOCIN

• if you are allergic to ofloxacin (or to other quinolone antibacterial agents) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using EXOCIN.
Inform your doctor if:

• you have had an allergic reaction to other quinolones
• you wear contact lenses
• you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart)
• you have an imbalance of certain minerals in your blood (especially low levels of potassium or magnesium)
• you have a very slow heart rate (called 'bradycardia')
• you have a weak heart (heart failure)
• you have a history of heart attack (myocardial infarction)
• you are female or elderly
• you are taking other medicines that may cause abnormal changes in the ECG (see section 'Other medicines and EXOCIN')
• you have previously had an injury/wound or an ulcer on the surface of the eye.

If you experience an allergic reaction to ofloxacin, stop using the medicine.
In patients who have taken quinolones orally or intravenously, including ofloxacin, serious and rare allergic (anaphylactic/anaphylactoid) reactions have been reported, some of which have been fatal, even after the first dose.
Some reactions were accompanied by circulatory collapse, loss of consciousness, rapid swelling of tissues (including swelling of the larynx, throat, or face), airway obstruction, shortness of breath, urticaria, and itching. These reactions may occur because a small amount of ofloxacin may be absorbed into the bloodstream after ocular administration.
Prolonged use may lead to a new bacterial infection that cannot be adequately treated with EXOCIN.
When using EXOCIN, consider the risk of the eye drops passing into the nose and back of the throat, which may promote the development of bacterial resistance. As with any other antibiotic, prolonged use may lead to overgrowth of microorganisms not responsive to ofloxacin; therefore, if no improvement is observed after 10 days, discontinue use and consult your ophthalmologist.
Corneal deposits (inflammatory deposits on the surface of the eye) have been reported in patients receiving ofloxacin eye drops, but it is unclear whether the eye drops were the cause.
Anterior eye damage has been reported in patients with pre-existing corneal injury/wound or ulcer when treated with fluorquinolone antibiotic eye drops. However, many of these reports included significant confounding factors such as advanced age, presence of large ulcers, concomitant ocular conditions (e.g. severe dry eye), systemic inflammatory diseases (e.g. rheumatoid arthritis), and concomitant use of ocular steroids or non-steroidal anti-inflammatory drugs. Nevertheless, caution is required regarding the risk of corneal perforation when using EXOCIN to treat patients with pre-existing corneal injury/wound or ulcer.
EXOCIN may potentially increase sensitivity to sunlight. During treatment with EXOCIN, avoid exposure to sunlight or direct sunlight.

Children
The safety and efficacy of the product in infants under one year of age have not been established; therefore, use is not recommended.
Neonates (children up to 28 days of age)
Information on the use of EXOCIN in neonates for the treatment of conjunctivitis is very limited.
Use of EXOCIN in neonates with neonatal ophthalmia caused by Neisseria gonorrhoeae or Chlamydia trachomatis is not recommended, as the product has not been evaluated in such patients.
Your doctor will decide the most appropriate treatment for the neonate.

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

• you are taking other medicines that may alter heart rhythm: medicines belonging to the class of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antimicrobials (macrolide class), or certain antipsychotics.

It has been shown that administration of drugs belonging to the same class as ofloxacin, when taken orally or injected, may affect how drugs such as theophylline or caffeine are processed by the body. However, studies have shown that ofloxacin does not have this effect.
Although there has been an increased number of reports of drowsiness, depression, and seizures when drugs of the same class as ofloxacin are taken concomitantly with non-steroidal anti-inflammatory drugs (such as aspirin, ibuprofen, diclofenac, etc.), such events have not been reported with the use of ofloxacin.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Due to the lack of adequate and well-controlled clinical studies in pregnant women and because systemic use of quinolones has caused joint problems in immature animals, use of this medicine during pregnancy is not recommended.
Use of this medicine during pregnancy and breastfeeding is not advised. Your doctor will decide whether to discontinue breastfeeding or treatment, taking into account the importance of the medicine for you.

Driving and using machines
No studies on the ability to drive or operate machinery have been conducted.
A temporary blurring of vision may occur immediately after using EXOCIN. In this case, do not drive or operate machinery until your vision has cleared.

EXOCIN contains benzalkonium chloride
This medicine contains 0.05 mg of benzalkonium chloride per 1 ml of solution, equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in 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 outer layer of the eye). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use EXOCIN

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 1–2 drops 4–6 times a day, or as prescribed by your doctor.
For the treatment of bacterial keratitis and infectious corneal ulcers, administration during the first two days of treatment may be more frequent (1–2 drops every 30 minutes during daytime), followed by a gradual reduction over the next 7 days to 1–2 drops every hour, completing treatment with 1–2 drops 4 times a day.
Treatment with EXOCIN should be limited to the period necessary to achieve clinical recovery.
EXOCIN may only be used as an ophthalmic solution: do not use for injections or intraocular administration.
If you use more EXOCIN than you should
Rinse the eye with water.
In case of accidental ingestion of an excessive dose of EXOCIN, contact your doctor immediately or go to the nearest hospital.
If you forget to use EXOCIN
Do not use a double dose to make up for the missed dose.
If you stop using EXOCIN
If you have any questions 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.
Serious side effects:
If you experience one or more of the following side effects, you may have had a severe allergic
reaction . Stop using Exocin immediately and contact your doctor.
Allergic reactions:
Frequency not known (cannot be estimated from the available data)

• Allergic reactions in the eye (including eye or eyelid itching)
• Skin inflammation due to allergy (including rash, itching or hives)
• Sudden, severe, life-threatening allergic reaction (anaphylactic), presenting with swelling under the skin which may occur in areas such as the face, lips or other body parts; swelling of the mouth, tongue or throat that may block the airways, causing wheezing, difficulty swallowing, breathing difficulties or shortness of breath
• Potentially life-threatening skin rashes have been reported with the use of EXOCIN (Stevens-Johnson syndrome, toxic epidermal necrolysis), which initially appear as red spots resembling a target or circular patches, often with central blisters, on the trunk.

The following side effects may also occur:
You should contact your doctor if any of the following side effects bother you or persist.
Common side effects (may affect up to 1 in 10 people)
Eye-related side effects

• Eye irritation
• Eye discomfort

Side effects with unknown frequency (cannot be estimated from the available data)
Eye-related side effects

• Inflammation of the clear front part of the eye
• Redness and inflammation of the thin layer covering the white part of the eye
• Blurred vision
• Sensitivity to light
• Swelling of the eyes
• Sensation of having something in the eye
• Increased tearing
• Swelling around the eyes (including eyelid swelling)
• Dry eyes
• Eye pain
• Eye redness

Body-related side effects

• Dizziness
• Nausea

Heart-related side effects

• Abnormally fast heartbeat
• Life-threatening irregular heartbeat
• Changes in heart rhythm (called 'QT interval prolongation', seen on ECG, the electrical activity of the heart).

To reduce the risk of side effects, use EXOCIN exactly as prescribed by your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 EXOCIN

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 "Expiry".
The expiry date refers to the last day of that month.
The stated expiry date applies to the product when kept in its original, undamaged packaging and
correctly stored.
Discard the bottle 28 days after first opening, even if some solution remains.
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.

6. Package contents and other information

What EXOCIN contains

• The active substance is ofloxacin 3 mg/ml
• The other components are benzalkonium chloride, sodium chloride, purified water.

Description of the appearance of EXOCIN and contents of the pack
EXOCIN is an eye drop solution packaged in a 10 ml bottle.
Marketing Authorization Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy
Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport, County Mayo, Ireland

Patient Information Leaflet

EXOCIN 3 mg/g ophthalmic ointment

Ofloxacin
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, consult 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What EXOCIN is and what it is used for
2. What you need to know before using EXOCIN
3. How to use EXOCIN
4. Possible side effects
5. How to store EXOCIN
6. Package contents and other information

1. What EXOCIN is and what it is used for

EXOCIN contains ofloxacin, which belongs to a group of medicines called fluoroquinolones.
Contact your doctor if you do not feel better or if you feel worse after 10 days.
EXOCIN 3 mg/g ophthalmic ointment is used to treat external eye infections
caused by germs sensitive to ofloxacin, leading to inflammation of the front covering
of the eye (conjunctivitis), or inflammation of the eyelid (blepharitis), or simultaneous
inflammation of the front covering of the eye and the eyelid (blepharoconjunctivitis), or
simultaneous inflammation of the cornea and the front covering of the eye
(keratoconjunctivitis), or inflammation of the tear sac (dacryocystitis), or inflammation of the
group of sebaceous glands present in the eyelid (meibomitis), or inflammation of the cornea
(keratitis). EXOCIN is also indicated for the prevention of infections following surgical procedures.

2. What you should know before using EXOCIN

Do not use EXOCIN

• if you are allergic to ofloxacin (or to other quinolone antibacterial agents) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using EXOCIN.
Inform your doctor if:

• you have had an allergic reaction to other quinolones,
• you wear contact lenses,
• you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart),
• you have an imbalance of certain minerals in your blood (especially low levels of potassium or magnesium),
• you have a very slow heart rate (called 'bradycardia'),
• you have weak heart function (heart failure),
• you have a history of heart attack (myocardial infarction),
• if you are female or elderly,
• you are taking other medicines that may cause abnormal changes in the ECG (see section 'Other medicines and EXOCIN'),
• you have previously had an injury/wound or ulcer on the surface of the eye.

If you experience an allergic reaction to ofloxacin, stop using the medicine.
Severe and occasionally fatal allergic (anaphylactic/anaphylactoid) reactions have been reported in patients treated with quinolones administered orally or intravenously, including ofloxacin, some occurring after the first dose.
Some of these reactions were accompanied by circulatory collapse, loss of consciousness, rapid swelling of tissues (including swelling of the larynx, throat or face), airway obstruction, shortness of breath, urticaria and itching. These reactions may occur because a small amount of ofloxacin may be absorbed into the bloodstream following ocular administration.
Prolonged use may lead to a new bacterial infection that may not be adequately treated with EXOCIN.
When using EXOCIN, consider the risk of the product draining into the nose and back of the throat, which may promote the development of bacterial resistance. As with any antibiotic, prolonged use may result in overgrowth of microorganisms not susceptible to ofloxacin; therefore, if no improvement is observed after 10 days, discontinue use and consult your ophthalmologist.
Corneal deposits (inflammatory deposits on the eye surface) have been reported in patients receiving ofloxacin eye drops, although it is unclear whether the eye drops were the cause.
Anterior eye damage has been reported in patients with pre-existing corneal injury/wound or ulcer when treated with fluorquinolone antibiotic eye drops. However, significant confounding factors were present in many of these reports, such as advanced age, presence of large ulcers, concomitant ocular conditions (e.g. severe dry eye), systemic inflammatory diseases (e.g. rheumatoid arthritis), and concomitant use of ocular steroids or non-steroidal anti-inflammatory drugs. Nevertheless, caution is required regarding the risk of corneal perforation when using EXOCIN to treat patients with pre-existing corneal injury/wound or ulcer.
EXOCIN may potentially increase sensitivity to sunlight. During treatment with EXOCIN, avoid exposure to sunlight or direct sun light.

Children
The safety and efficacy of this product in infants under one year of age have not been established; therefore, use is not recommended.
Neonates (children up to 28 days of age)
Information on the use of EXOCIN in neonates for the treatment of conjunctivitis is very limited.
Use of EXOCIN in neonates with ophthalmia neonatorum caused by Neisseria gonorrhoeae or Chlamydia trachomatis is not recommended, as the product has not been evaluated in such patients.
Your doctor will decide the most appropriate treatment for the neonate.

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

• you are taking other medicines that may alter heart rhythm: drugs belonging to the antiarrhythmic class (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (macrolide class), some antipsychotics.

It has been shown that administration of drugs belonging to the same class as ofloxacin, when taken orally or by injection, may affect how drugs such as theophylline or caffeine are absorbed by the body. However, studies have shown that ofloxacin does not have this effect.
Although there have been increased reports of drowsiness, depression, and seizures when drugs of the same class as ofloxacin are taken concomitantly with non-steroidal anti-inflammatory drugs (such as aspirin, ibuprofen, diclofenac, etc.), these have not been reported with ofloxacin use.

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.
Due to the lack of adequate and well-controlled clinical studies in pregnant women and because systemic use of quinolones has caused joint problems in immature animals, use of this medicine during pregnancy is not recommended.
Use of this medicine during pregnancy and breastfeeding is not recommended. Your doctor will decide whether to discontinue breastfeeding or treatment, taking into account the importance of the medicine for you.

Driving and using machines
No studies on the ability to drive vehicles or use machines have been conducted.
Transient blurred vision may occur immediately after using EXOCIN. If this happens, do not drive or operate machinery until your vision has cleared.

EXOCIN eye ointment contains purified lanolin, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use EXOCIN

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 application 3–4 times daily, or as prescribed by your doctor.
Treatment with EXOCIN should be limited to the period necessary to achieve clinical healing.
EXOCIN may only be used as an ointment for ophthalmic use.

If you use more EXOCIN than you should
Cases of overdose have not been reported.
In case of overdose, rinse the eye with water.
In case of accidental ingestion of an excessive dose of EXOCIN, contact your doctor immediately or go to the nearest hospital.

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

If you stop using EXOCIN
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.
Serious side effects:
If you experience one or more of the following side effects, you may have had a severe allergic
reaction . Stop using EXOCIN immediately and contact your doctor.
Allergic reactions:
Frequency not known (cannot be estimated from the available data)

• Allergic reactions in the eye (including eye and/or eyelid itching)
• Skin inflammation due to allergy (including: skin rash, itching or hives)
• Sudden, severe, life-threatening allergic reaction (anaphylactic reaction) causing swelling under the skin, which may occur in areas such as the face, lips or other parts of the body; swelling of the mouth, tongue or throat that may block the airways, causing wheezing, difficulty swallowing, breathing difficulties or shortness of breath
• Potentially life-threatening skin rashes have been reported with the use of EXOCIN (Stevens-Johnson syndrome, toxic epidermal necrolysis), which initially appear as red, target-like spots or circular patches, often with central blisters, on the trunk.

The following side effects may also occur:
You should contact your doctor if any of the following side effects cause you problems or persist.
Common side effects (may affect up to 1 in 10 people)
Eye-related side effects

• Eye irritation
• Eye discomfort

Side effects with unknown frequency (cannot be estimated from the available data)
Eye-related side effects

• Inflammation of the clear front part of the eye
• Redness and inflammation of the thin layer covering the white part of the eye
• Blurred vision
• Light sensitivity
• Swelling of the eyes
• Feeling of a foreign body in the eye
• Increased tearing
• Dry eyes
• Eye pain
• Eye redness

Side effects affecting the body

• Dizziness
• Nausea

Side effects affecting the heart

• Abnormally fast heart rate
• Life-threatening irregular heart rhythm
• Changes in heart rhythm (known as QT interval prolongation, seen on ECG, the heart's electrical activity)

To reduce the risk of side effects, use EXOCIN exactly as prescribed by your doctor.
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 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 EXOCIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.
The expiry date refers to the last day of that month.
The stated expiry date applies to the product while it is unopened and stored correctly.
Discard the container 28 days after first opening, even if there is still ophthalmic ointment remaining.
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.

6. Package contents and other information

What EXOCIN contains

• The active substance is ofloxacin 3 mg/g.
• The other ingredients are purified lanolin, liquid paraffin, white soft paraffin.

Description of the appearance of EXOCIN and contents of the pack
EXOCIN is an ophthalmic ointment supplied in a 3.5 g tube.
Marketing Authorization Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy
Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22
Pomezia (Rome)