Oftaquix

Patient Information Leaflet

Keep this leaflet! Information on the immediate packaging is in a foreign language.
Oftaquix, 5 mg/ml, eye drops, solution
Levofloxacinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

1. What Oftaquix is and what it is used for

Levofloxacin is an antibiotic belonging to a group called fluoroquinolones (sometimes abbreviated as quinolones). The medicine works by killing certain types of bacteria that may cause infections.
Levofloxacin in the form of eye drops is used in children over 1 year of age, adolescents, and adults for the treatment of bacterial infections affecting the front part of the eye.
One such infection is bacterial conjunctivitis, which is an infection of the outer membrane of the eye (conjunctiva).
Use of Oftaquix is not recommended in children under 1 year of age.
If there is no improvement after 5 days of treatment, or if symptoms worsen, consult your doctor.

2. Important information before using Oftaquix

When not to use Oftaquix:

• If the patient is allergic to levofloxacin or other quinolones, or to any of the other ingredients of this medicine (listed in section 6)

In case of doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Oftaquix, discuss this with your doctor, pharmacist, or
nurse

• if allergic reactions occur, even after a single dose, the use of the medicine should be discontinued
• if during treatment the patient notices worsening of eye-related symptoms, they should contact a doctor immediately
• if after a period of treatment determined by the doctor there are no signs of recovery, the patient should contact a doctor immediately
• in general, wearing any type of contact lenses is not allowed during eye infection.
• Oftaquix contains a preservative - benzalkonium chloride, which may cause eye irritation (additional information is provided below).

Swelling and tendon rupture have occurred in patients taking oral or intravenous
fluoroquinolones, particularly in elderly patients and patients concurrently treated
with corticosteroids. Treatment with Oftaquix should be discontinued if tendon pain or
swelling (tendonitis) occurs.
Children and adolescents
Special warnings and precautions for use are the same for adults, adolescents, and children aged one year and above.
Oftaquix and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for use. In particular, inform your doctor or pharmacist about the use of any other eye drops or ointments before starting treatment with Oftaquix.
If the patient uses other eye drops, at least 15 minutes should elapse between administration of Oftaquix and other eye drops.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Oftaquix may be used in pregnant women only if the expected benefit justifies the potential risk to the fetus.
Levofloxacin passes into the bloodstream and breast milk in very small amounts after administration of eye drops; the likelihood of causing harm to the developing child is very low.
The doctor is aware of the potential risks and will advise the patient whether to use Oftaquix eye drops in such circumstances.
Oftaquix may be used during breastfeeding only if the expected benefit justifies the potential risk to the breastfed infant.
When used as directed, Oftaquix does not impair fertility (the ability to conceive or father a child).
Driving and operating machinery
Oftaquix has negligible influence on the ability to drive and operate machinery.
If the eye drops cause blurred vision, the patient should wait until full visual acuity is restored before driving or operating machinery.
Oftaquix contains benzalkonium chloride
This medicine contains approximately 0.002 mg of benzalkonium chloride per drop, corresponding to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (transparent layer at the front of the eye). If abnormal sensations in the eye, such as stinging or eye pain, occur after using the medicine, contact a doctor.

3. How to use Oftaquix

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Oftaquix eye drops are intended for ocular use and must be applied to the external surface of the eye.
For patients over one year of age, the recommended dosage is:
DAYS 1–2

• one or two drops into the conjunctival sac of the infected eye(s) every two hours
• up to eight times per day.

DAYS 3–5

• one or two drops into the conjunctival sac of the infected eye(s)
• up to four times per day.

Dosage adjustment is not necessary in elderly patients.
Treatment usually lasts five days. The doctor will inform the patient how long the drops should be used. If
the patient is using any other eye medication, at least 15 minutes should elapse between the administration of
different types of eye drops.
Use in children and adolescents
There is no need to adjust the dose in children over one year of age and adolescents.
Oftaquix is not recommended for use in children under one year of age.
Before administering the drops:
If possible, ask another person to administer the drops. Before giving the drops,
patients should ask these individuals to read this instruction leaflet while the patient is present.

1. Wash hands thoroughly.
2. Open the bottle. Take special care not to touch the eyelid, surrounding eye area, or fingers with the dropper tip.

3) Tilt your head backward, hold the bottle upside down over the eye.
4) Gently pull the lower eyelid downward and look upward. Squeeze the container gently to release a single drop into the space between the lower eyelid and the eye.
5) Close the eye and press the inner corner of the eye with a finger for about one minute. This helps prevent the drop from draining through the tear duct.

6. Wipe away any excess solution from the skin around the eyes.
7. Replace the cap and close the bottle.
   If an additional drop is required, and also when treatment involves both eyes, repeat the steps described in steps 3 to 7.
   Oftaquix eye drops must not be injected into the inner part of the eyeball.

Use of a higher than recommended dose of Oftaquix:
In case of overdose, rinse the eye(s) with clean water and inform your doctor or pharmacist.

Missed dose of Oftaquix:
If you forget to use the eye drops, apply the next dose as soon as you remember. Do not use a double dose to make up for a missed dose.

Accidental swallowing of eye drops:
The amount of levofloxacin contained in the bottle is too small to cause adverse effects. However, if in doubt, consult your doctor or pharmacist, who will advise on necessary measures.

Stopping treatment with Oftaquix eye drops, solution, earlier than prescribed by your doctor may prolong the healing process.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
They occur in approximately one out of ten people using Oftaquix. Most of these adverse reactions
affect only the eye and may not last long. If a patient experiences any severe or persistent adverse
reaction, treatment with Oftaquix should be discontinued and immediate medical advice should be sought.
There is a possibility of developing an allergic reaction to this medicine.
The following allergic reactions may rarely occur (may affect up to 1 in 1,000 people):

• worsening of eye redness and itching
• sudden eyelid swelling or worsening of existing swelling

The following allergic reactions may very rarely occur (may affect up to 1 in 10,000 people):

• swelling or tightness in the throat
• breathing difficulties. The above symptoms may occur even after a single dose of Oftaquix.

If any of the above adverse reactions occur, treatment with Oftaquix should be discontinued and
immediate contact should be made with a doctor or the nearest hospital Emergency Department.
Additionally, the following may occur:
Common adverse reactions (may affect up to 1 in 10 people)

• burning sensation in the eye
• blurred vision or mucous discharge in the conjunctival sac

Uncommon adverse reactions (may affect up to 1 in 100 people)

• headache
• burning or irritation of the eyes
• swelling or redness (bloodshot eyes) of the conjunctiva (the front layer covering the eye)
• skin rash around the eyes
• itchy eyes
• eye pain
• dryness or discomfort in the eyes
• light sensitivity
• eyelid sticking together
• nasal congestion or runny nose

Rare adverse reactions (may affect up to 1 in 1,000 people)

• allergic reactions such as skin rash

Additional adverse reactions in children and adolescents
The frequency, type, and severity of adverse reactions in children and adolescents are expected to be the same as in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Oftaquix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label after "Felh." and on the carton after "EXP". The expiry date refers to the last day of the stated month. The code "Lot" on the carton and "Gy.sz." on the bottle label refers to the batch number.
Do not use this medicine if, in a new bottle, the plastic seal around the dropper and nozzle is missing or damaged.
Keep the bottle tightly closed.
To prevent contamination of the drops, discard the bottle 28 days after first opening and use a new bottle.
Medicines should not be disposed of 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 the medicine contains Oftaquix

• The active substance is levofloxacin. 1 ml contains 5.12 mg of levofloxacin hemihydrate, equivalent to 5 mg of levofloxacin.
• Other components of the medicine are: benzalkonium chloride, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

What Oftaquix looks like and contents of the pack

• Oftaquix is a clear solution, pale yellow to pale greenish-yellow in colour, without visible solid particles.
• The pack contains a white bottle with 5 ml of solution. The bottle is made of LDPE with an LDPE dropper and an HDPE cap, in a cardboard box.

For further information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Hungary, country of export:
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer:
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Hungary, country of export Marketing Authorisation Number: OGYI-T-10257/01
Parallel Import Marketing Authorisation Number: 254/25
This medicinal product is authorised for marketing in the European Economic Area under the following names:
This medicinal product is authorised under the name Oftaquix in the following European Economic Area member states:
Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Poland, Portugal, Romania, Slovakia, Sweden, United Kingdom