OFLATON 3 mg /Ml Eye Drops, Solution

Зміст інструкції

1. OFLATON 3 mg/ml eye drops, solution
   1. What is OFLATON and what is it 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

OFLATON 3 mg/ml eye drops, solution

Ofloxacin

Read this leaflet carefully before you start 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 OFLATON is and what it is used for
• 2. What you need to know before you use 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 is OFLATON and what is it used for

OFLATON contains the active substance ofloxacin. Ofloxacin is an antibiotic that belongs to a
group of drugs called fluoroquinolones.
Consult your doctor if you do not feel better or if you feel worse after 10 days.
OFLATON 3 mg/ml eye drops are used for the treatment of external eye infections caused by germs sensitive
to ofloxacin, which lead to inflammation of the anterior lining of the eye (conjunctivitis), or to
inflammation of the eyelid (blepharitis), to simultaneous inflammation of the anterior lining of the eye and
the eyelid (blepharoconjunctivitis), to simultaneous inflammation of the cornea and the anterior lining
of the eye (keratoconjunctivitis), to inflammation of the lacrimal sac (dacryocystitis), to inflammation of the
group of sebaceous glands present in the eyelid (meibomitis) to 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 ingredient (or to other antibacterial quinolone agents) or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using OFLATON
Tell your doctor if:

• you have experienced an allergy to other quinolones
• you wear contact lenses
• you were born with or have a family history of prolonged QT interval (displayed on an ECG, an electrical recording of the heart)
• you have an imbalance of certain minerals in the blood (especially a low level 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 a woman or an elderly patient;
• you are taking other medicines that can cause abnormal changes in the ECG (see section “Other medicines and OFLATON”).
• you have had a lesion/wound or an ulcer on the surface of the eye in the past.

If you experience an allergic reaction to ofloxacin, stop taking the medicine.
Serious and rare allergic (anaphylactic/anaphylactoid) reactions, sometimes fatal, have been reported in patients who have taken quinolones orally or intravenously, including ofloxacin, some following the first dose.
Some reactions were accompanied by a severe decrease in blood pressure with a weak and accelerated 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 after ocular administration.
Therefore, if you experience an allergic reaction during therapy with the medicine, stop treatment and seek immediate medical attention.
During the use of LIAFLOX avoid exposure to sunlight or UV rays as you may develop sensitivity to light (photosensitivity).
LIAFLOX is for ophthalmic use only, do not use this medicine for injections inside the eye.
Avoid using contact lenses during therapy with LIAFLOX.
Swelling and rupture of tendons have occurred in people taking fluoroquinolones orally or intravenously, especially in elderly patients and those treated concurrently with corticosteroids.
Stop taking LIAFLOX if you begin to experience pain or swelling of the tendons (tendinitis).
Prolonged use of ofloxacin may cause a new bacterial infection that cannot be adequately treated with OFLATON.
When using OFLATON, consider the risk of the eye drops passing into the nose and the back of the throat, which may cause the development of bacterial resistance. Like any other antibiotic, prolonged use can cause an excessive growth of microorganisms that do not respond to ofloxacin; therefore, if you do not notice an improvement after 10 days, stop using it and consult an ophthalmologist.
Corneal precipitates (inflammatory deposits on the surface of the eye) have been reported in patients who have received ofloxacin eye drops, but it is not clear whether the eye drops were the cause.
Damage to the front of the eye has been reported in patients with pre-existing lesions/wounds or ulcers on the surface of the eye when treated with fluoroquinolone antibiotic eye drops.
However, significant elements of confusion have been found in many of these reports, such as advanced age, the presence of large ulcers, concomitant eye 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. However, caution should be exercised regarding the risk of corneal perforation when using OFLATON to treat patients with pre-existing lesions/wounds or ulcers on the surface of the eye.

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

Infants (Children up to 28 days of age)
Information on the use of ofloxacin in infants in the treatment of conjunctivitis is very limited. The use of ofloxacin in infants with ophthalmia neonatorum caused by Neisseria gonorrhoeae or Chlamydia trachomatis is not recommended as the use of the product has not been evaluated in these patients.
Your doctor will decide the best treatment for the infant.

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

• you are taking other medicines that can alter the heart rate such as: medicines that belong to the class of antiarrhythmics (for example quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the class of macrolides), some antipsychotics used to treat mental and behavioral disorders.

Cases of altered metabolism of caffeine and theophylline (used to treat asthma) have been reported with the administration of some Quinolones in the body (systemically). However, it has been shown that ofloxacin via systemic route (in the body) does not significantly affect its metabolism.
In addition, with the concomitant administration of Quinolones and non-steroidal anti-inflammatory drugs (NSAIDs), an increase in toxicity at the central nervous system level has been reported. However, this toxicity has not occurred with the concomitant systemic use of ofloxacin and non-steroidal anti-inflammatory drugs (NSAIDs).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
As there are no adequate and well-controlled clinical studies in pregnant women and since systemic use of quinolones has caused problems with the joints in immature animals, the use of the medicine is not recommended during pregnancy.
Therefore, the use of LIAFLOX during pregnancy is not recommended.
Breastfeeding
Since quinolone antibiotics administered in the body (systemically) pass into breast milk, there may be a risk to the infant.
Consult your doctor to assess whether to discontinue breastfeeding or therapy, taking into account the importance of the medicine for the mother.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and operate machinery.
Transient blurred vision may occur immediately after using OFLATON. In this case, do not drive vehicles or use machinery until vision returns to normal.

OFLATON “multidose” contains benzalkonium chloride
OFLATON in the multidose formulation contains 0.05 mg of benzalkonium chloride in 1 ml of solution, equivalent to 0.05 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their color. Remove 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 OFLATON

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have 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 infectious keratitis and corneal ulcers of bacterial origin, administration in the
first two days of treatment may be more frequent (1-2 drops every 30 minutes, during the day), then
in the following 7 days the dose must be gradually reduced to 1-2 drops every hour until completing
the treatment with 1-2 drops 4 times a day.
Treatment with OFLATON should be limited to the period necessary to achieve clinical healing.
OFLATON can 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 for use.
• Close the bottle immediately after use. To avoid any contamination, do not bring the dropper into contact with any surface, nor into direct contact with the eye. 0.5 ml single-dose container
• 1. Open the container by detaching the cap.
• 2. Apply gentle pressure to the body of the container to apply one drop of solution to the affected ocular surface.

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

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

If you stop using OFLATON
Continue treatment with the medicine as indicated by your doctor in order to achieve
complete healing.
If you have any doubts about the use of this medicine, ask 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 serious allergic reaction.
Stop using OFLATON immediately and contact your doctor.
Allergic reactions:
Frequency not known (cannot be estimated from available data)

• allergic reactions in the eye (including itchy eyes and/or eyelids)
• skin inflammation due to allergy (including: rash, itching or hives)
• sudden, severe allergic reaction (anaphylactic) that is life-threatening, presenting with swelling under the skin that can occur in areas such as the face, lips or other parts of the body; swelling of the mouth, tongue or throat that can obstruct the airways, which can cause wheezing, difficulty swallowing, breathing or shortness of breath
• with the use of OFLATON, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, which initially appear as reddish 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 these side effects cause you problems or persist.

Common side effects(may affect up to 1 in 10 people)
Side effects affecting the eye

• eye irritation
• eye discomfort

Side effects with frequency not known(cannot be estimated from available data)
Side effects affecting the eye

• 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
• feeling that something is in the eye
• increased tearing
• swelling around the eyes (including eyelid swelling)
• dry eye
• 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,
• alteration of the heart rhythm (called ‘prolongation of the QT interval’, seen on ECG, heart electrical activity).

To reduce the risk of side effects, use OFLATONas prescribed by your doctor.

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 OFLATON

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.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Keep 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:
Use the medicine immediately after opening the single-dose container; if partially used,
discard any remaining medicine as it does not contain preservatives.
Use the medicine within 3 months after first opening the aluminium sachet.
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 OFLATON contains
Multidose bottle of 10 ml
The active ingredient is: ofloxacin. 1 ml of eye drops contains 3.00 mg of ofloxacin.
The other ingredients are: benzalkonium chloride, sodium chloride, hydrochloric acid, water for injections.
Single-dose containers of 0.5 ml
The active ingredient is: ofloxacin. 1 ml of eye drops contains 3.00 mg of ofloxacin.
The other ingredients are: sodium chloride, hydrochloric acid, water for injections.

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

Marketing Authorisation 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)