Oflaton

Package leaflet: Information for the patient

OFLATON 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, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OFLATON is and what it is used for

OFLATON 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.
OFLATON 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 lining of the eye (conjunctivitis), or inflammation of the eyelid (blepharitis), simultaneous inflammation of the front lining of the eye and the eyelid (blepharoconjunctivitis), simultaneous inflammation of the cornea and the front lining of the eye (keratoconjunctivitis), inflammation of the tear sac (dacryocystitis), inflammation of the group of sebaceous glands present in the eyelid (meibomitis), or inflammation of the cornea (keratitis).
OFLATON is also indicated for the treatment of ulcers on the surface of the eye caused by infections and to prevent infections following surgical procedures.

2. What you need to know before using OFLATON

Do not use OFLATON

• 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 OFLATON.
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 OFLATON”)
• you have previously had an injury/wound or ulcer on the surface of your eye.

If you experience an allergic reaction to ofloxacin, stop using the medicine immediately.
Severe and occasionally fatal allergic (anaphylactic/anaphylactoid) reactions have been reported in patients treated with quinolones administered orally or intravenously, including ofloxacin, with some cases occurring after the first dose.
Some of these reactions were accompanied by severe drop in blood pressure with weak and rapid heartbeat (cardiovascular collapse), loss of consciousness, rapid swelling of the legs, face, mucous membranes or tongue (angioedema), including swelling of the larynx, pharynx or face, airway obstruction, shortness of breath, hives and itching. These reactions may occur because a small amount of ofloxacin may be absorbed into the bloodstream following ocular administration.
Therefore, if an allergic reaction occurs during treatment with this medicine, stop treatment immediately and contact your doctor without delay.
During treatment with LIAFLOX, avoid exposure to sunlight or 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 oral or intravenous fluorquinolones, particularly in elderly patients and those receiving concomitant corticosteroid therapy.
Stop using LIAFLOX if you develop tendon pain or swelling (tendinitis).
Prolonged use of ofloxacin may lead to a new bacterial infection that may not be adequately treated with OFLATON.
When using OFLATON, consider the risk of the eye drops draining into the nose and back of the throat, which may promote 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 precipitates (inflammatory deposits on the eye surface) have been reported in patients using 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 injuries/wounds or ulcers when treated with fluorquinolone antibiotic eye drops.
However, significant confounding factors have been noted 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 OFLATON to treat patients with pre-existing corneal injuries/wounds or ulcers.

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.
Neonates (children up to 28 days of age)
Information on the use of ofloxacin in neonates for the treatment of conjunctivitis is very limited. Use of ofloxacin is not recommended in neonates with neonatal ophthalmia 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 neonate.

Other medicines and OFLATON
Tell 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 affect heart rhythm, such as: drugs belonging to the antiarrhythmic class (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.

Cases of altered metabolism of caffeine and theophylline (used to treat asthma) have been reported with systemic administration (into the body) of certain quinolones. However, systemic ofloxacin has been shown not to significantly affect their metabolism.
Additionally, concomitant use of quinolones and non-steroidal anti-inflammatory drugs (NSAIDs) has been associated with increased central nervous system toxicity. However, such 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, use of this medicine during pregnancy is not recommended.
Therefore, 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 therapy, taking into account the importance of the drug for the mother.

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

OFLATON “multi-dose” contains benzalkonium chloride
OFLATON in the multi-dose 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 cause discoloration. 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 OFLATON

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 1-2 drops 4-6 times daily, or as prescribed by your physician.
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 waking hours), followed by a gradual reduction over the next 7 days to 1-2 drops every hour, until completing treatment with 1-2 drops 4 times daily.

Treatment with OFLATON should be limited to the period necessary to achieve clinical healing.
OFLATON must be used only as an ophthalmic solution: do not use for injections or intraocular administration.

Instructions for use
10 ml bottle

• Unscrew the cap; the bottle is ready for use.
• Close the bottle immediately after use. To avoid contamination, do not let the dropper tip touch any surface or 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 instill one drop of solution onto the affected ocular surface.

If you use more OFLATON than you should
If you have used an excessive dose of OFLATON, rinse the eye with water.
In case of accidental ingestion of an excessive dose of OFLATON, contact your doctor immediately or go to the nearest hospital.

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

If you stop using OFLATON
Continue treatment with the medicine as directed by your doctor in order to achieve complete healing.

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 be having a severe allergic reaction.
Stop using OFLATON 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 obstruct the airways, causing wheezing, difficulty swallowing, breathing difficulties, or shortness of breath
• potentially life-threatening skin rashes have been reported with the use of OFLATON (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 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 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
• sensitivity to light
• eye swelling
• 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 heart rate
• life-threatening irregular heart rhythm
• changes in heart rhythm (called 'QT interval prolongation', seen on ECG, the heart's electrical activity).

To reduce the risk of side effects, use OFLATON exactly as prescribed by your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website: 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 OFLATON

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.
The indicated expiry date applies to the product in its original, undamaged packaging, correctly stored.
Store the product in its original packaging.

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

OFLATON single-dose units:
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. Contents of the pack and other information

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

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

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)