LIAFLOX

Package leaflet: Information for the patient

LIAFLOX 3 mg/ml eye drops, solution

Ofloxacin
Please read all of 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LIAFLOX is and what it is used for

LIAFLOX contains the active substance ofloxacin. Ofloxacin is an antibiotic that 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.
LIAFLOX 3 mg/ml eye drops solution 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).
LIAFLOX is also indicated for the treatment of corneal ulcers caused by infections and to prevent infections following eye surgery.

2. What you should know before using LIAFLOX

Do not use LIAFLOX

• if you are allergic to the active substance (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 LIAFLOX.
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)
• you are a woman or an elderly patient
• you are taking other medicines that may cause abnormal changes in the ECG (see section “Other medicines and LIAFLOX”)
• 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 treated with quinolones administered orally or intravenously, including ofloxacin, severe and
occasional allergic (anaphylactic/anaphylactoid) reactions have been reported, some of which were fatal,
including after the first dose.
Some of these reactions were accompanied by a severe drop in blood pressure with weak and rapid heartbeat
(cardiovascular collapse), loss of consciousness, rapid swelling of the legs, arms, face, mucous membranes,
or tongue (angioedema), including swelling of the larynx, pharynx, 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.
Therefore, if an allergic reaction occurs during treatment with this medicine, stop treatment immediately and
consult your doctor without delay.
During treatment with LIAFLOX, avoid exposure to sunlight or ultraviolet (UV) rays, as you may develop
light sensitivity (photosensitivity).
LIAFLOX is for ophthalmic use only; do not use this medicine for intraocular injections.
Avoid wearing contact lenses during treatment with LIAFLOX.
Tendon swelling and rupture have been reported in people taking fluorquinolones orally or intravenously,
particularly in elderly patients and in those receiving concomitant corticosteroid therapy.
Stop using LIAFLOX if you begin to experience tendon pain or swelling (tendinitis).
Prolonged use of ofloxacin may lead to a new bacterial infection that cannot be adequately treated with
LIAFLOX.
When using LIAFLOX, consider the risk of the eye drops draining into the nose and back of the throat, which
may promote the development of bacterial resistance. As with any 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 precipitates (inflammatory deposits on the surface of the eye) have been reported in patients treated
with 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 have been observed 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 (NSAIDs). Nevertheless, caution is required regarding the risk of corneal perforation when using
LIAFLOX to treat patients with pre-existing corneal injury/wound or ulcer.

Children
The safety and efficacy of ofloxacin use in children under one year of age have not been established, and
therefore use of the product is not recommended.

Newborns (children up to 28 days of age)
Information on the use of ofloxacin in newborns for the treatment of conjunctivitis is very limited. Use of
ofloxacin is not recommended in newborns with ophthalmia neonatorum caused by Neisseria gonorrhoeae or
Chlamydia trachomatis, as the product has not been evaluated in such patients.
Your doctor will decide the most appropriate treatment for the newborn.

Other medicines and LIAFLOX
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, such as: antiarrhythmic agents (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antimicrobials (macrolide class), or certain antipsychotics used to treat mental and behavioral disorders.

Following systemic administration (into the body) of certain quinolones, altered metabolism of caffeine and theophylline (used to treat asthma) has been reported. However, systemic ofloxacin has been shown not to significantly affect their metabolism. Additionally, concomitant administration of quinolones and non-steroidal anti-inflammatory drugs (NSAIDs) has been associated with increased central nervous system toxicity. However, this toxicity has not been observed with concomitant systemic use of ofloxacin and NSAIDs.

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
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, the use of this medicine during pregnancy is
not recommended.
Therefore, the use of LIAFLOX during pregnancy is not advised.

Breastfeeding
Since quinolone antibiotics administered systemically pass into breast milk, there may be a risk to the
nursing infant.
Consult your doctor to evaluate whether to discontinue breastfeeding or the treatment, taking into account the
importance of the medicine for the mother.

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 LIAFLOX. If this occurs, do not drive or operate
machinery until your vision has cleared.

LIAFLOX “multidose” contains benzalkonium chloride
LIAFLOX in the multidose formulation 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 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
outermost transparent 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 LIAFLOX

Use this medicine exactly as prescribed 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), then over the
following 7 days the dose should be gradually reduced to 1-2 drops every hour, until completing
treatment with 1-2 drops 4 times a day.
Treatment with LIAFLOX should be limited to the period necessary to achieve clinical recovery.
LIAFLOX may only be used as an eye drop for ophthalmic use: do not use for injections or intraocular use.
Instructions for use
10 ml bottle

• Unscrew the cap, and the bottle is ready to use.
• Close the bottle immediately after use. To avoid any contamination, do not let the dropper tip touch any surface, nor come into direct contact with the eye.
  Single-dose container 0.5 ml
  1. Open the container by removing the cap.
  2. Gently squeeze the body of the container to apply one drop of solution onto the affected ocular surface.

If you use more LIAFLOX than you should
If you have used an excessive dose of LIAFLOX, rinse the eye with water.
In case of accidental ingestion of an excessive dose of LIAFLOX, contact your doctor immediately or go to the nearest hospital.
If you forget to use LIAFLOX
Do not use a double dose to make up for the missed dose.
If you stop using LIAFLOX
Continue treatment with the medicine as directed by your doctor in order to achieve complete recovery.
If you have any doubts about how to use 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 be having a severe allergic reaction.
Stop using LIAFLOX 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 rash, itching, or hives)
• sudden, severe life-threatening allergic reaction (anaphylactic reaction), presenting with 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 LIAFLOX (Stevens-Johnson syndrome, toxic epidermal necrolysis), which initially appear as reddish target-like spots or circular patches, often with central blisters, usually on the trunk.

The following side effects may also occur:
You should contact your doctor if any of these 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 frequency not known (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
• eye swelling
• sensation of having something in the eye
• increased tearing
• swelling around the eyes (including eyelid swelling)
• dry eye
• 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 (known as 'QT interval prolongation', visible on ECG, the heart's electrical activity).

To reduce the risk of side effects, use LIAFLOX 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store LIAFLOX

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 packaging after "Exp.".
The expiry date refers to the last day of that month.
The stated expiry date applies to the product when unopened and stored correctly.
Store the product in its original packaging.

LIAFLOX 10 ml bottle:
Discard the bottle 28 days after first opening, even if some solution remains.

LIAFLOX single-dose container:
Use the medicine immediately after opening the single-dose container; if only partially used, discard any remaining medicine, as it does not contain preservatives.
Use the medicine within 3 months after first opening the aluminium pouch.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What LIAFLOX contains
Multidose bottle of 10 ml
The active substance is: ofloxacin. 1 ml of eye drops solution contains 3.00 mg of ofloxacin.
The other components are: benzalkonium chloride, sodium chloride, hydrochloric acid, water for injections.

Single-dose containers of 0.5 ml
The active substance is: ofloxacin. 1 ml of eye drops solution contains 3.00 mg of ofloxacin.
The other components are: sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of LIAFLOX and package contents
Eye drops, solution.
Carton pack containing one 10 ml bottle with dropper.
Carton pack containing 20 single-dose containers of 0.5 ml each, divided into strips enclosed in an aluminium pouch.

Marketing Authorization Holder
Genetic S.p.A. Via G. Della Monica, 26 – 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)