Oftaquix

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
OFTAQUIX
5 mg/ml, eye drops, solution
Levofloxacinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Table of 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 referred to simply 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 one year of age.
If there is no improvement after 5 days of treatment, or if the patient feels worse, consult a doctor.

2. Important information before using OFTAQUIX medicine

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)

If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with OFTAQUIX, discuss it with your doctor, pharmacist, or
nurse.

• If allergic reactions occur, even after a single dose, use of the medicine should be discontinued immediately.
• If during treatment the patient notices worsening of eye-related symptoms, they should contact a doctor immediately.
• If after a period of treatment prescribed by the doctor there are no signs of improvement, the patient should contact a doctor immediately.
• Generally, no type of contact lenses should be worn during an eye infection.
• OFTAQUIX contains a preservative – benzalkonium chloride, which may cause eye irritation (additional information below).

Swelling and tendon rupture have occurred in patients taking oral or intravenous fluorochinolones, particularly in elderly patients and patients receiving concomitant corticosteroid therapy. Treatment with OFTAQUIX should be discontinued if pain or swelling of the tendon (tendonitis) occurs.
Children and adolescents
Special warnings and precautions for use are the same for adults, adolescents, and children aged one year and above.
Interaction of OFTAQUIX with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to 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 is using 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 may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
OF TAQUIX may be used in pregnant women only if the expected benefit justifies the potential risk to the fetus.
Levofloxacin passes into blood 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 informed about the potential risk and will advise the patient whether to use OFTAQUIX eye drops in such circumstances.
OF TAQUIX may be used during breastfeeding only if the expected benefit justifies the potential risk to the breastfed child.
When used according to recommendations, OFTAQUIX does not impair fertility (ability to conceive or father a child).
Driving and operating machinery
OF TAQUIX 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.
OF TAQUIX 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 of the drops 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 (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, contact a doctor.

3. How to use OFTAQUIX medicine

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
OFOTAPIX eye drops are intended for ocular use and must be administered 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 a maximum of eight times per day.

DAYS 3–5

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

In elderly patients, modification of the recommended dose is not necessary.
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 after the first year of life and adolescents.
OFOTAPIX 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 administering the drops,
ask these individuals to read these instructions in the patient's presence.

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

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

6. Wipe off any excess solution from the skin around the eyes.
7. Replace the cap and close the bottle.
   If an additional drop is required, and when treatment involves both eyes, repeat the steps described in steps 3 to 7.
   Do not inject OFTAQUIX eye drops into the interior of the eyeball.

Use of a higher than recommended dose of OFTAQUIX:
If a higher dose is used, rinse the eye(s) with clean water and inform your doctor or pharmacist.

Missed dose of OFTAQUIX eye drops:
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 recommended by your doctor may prolong the healing process.

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

4. Possible side effects

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

• worsening of redness and itching of the eyes
• sudden swelling of the eyelids or worsening of existing swelling

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

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

If any of the above side effects occur, treatment with OFTAQUIX should be stopped and
immediate contact should be made with a doctor or the nearest hospital Emergency Department.
In addition, the following may occur:
Common side effects (may affect up to 1 in 10 people)

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

Uncommon side effects (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)
• rash around the eyes
• itching of the eyes
• eye pain
• dryness or soreness of the eyes
• sensitivity to light
• sticking together of eyelids
• blocked nose or runny nose

Rare side effects (may affect up to 1 in 1,000 people):

• allergic reactions such as skin rash

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

5. How to store OFTAQUIX

Keep this medicine out of sight and reach of children.
Store the bottle tightly closed.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month. The abbreviations "Lot" and "Lote" indicate the batch number.
Do not use this medicine if, in a new bottle, there is no plastic seal around the dropper tip and cap, or if the seal is damaged.
To prevent contamination of the drops, discard the bottle 28 days after first opening and use a new bottle.
Medicines must 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. Contents of the pack and other information

What OFTAQUIX contains

• The active substance is levofloxacin. 1 ml of eye drops, solution contains 5.12 mg of levofloxacin hemihydrate, equivalent to 5 mg of levofloxacin.
• The other ingredients are benzalkonium chloride, sodium chloride, sodium hydroxide or hydrochloric acid, water for injections.

What OFTAQUIX looks like and contents of the pack

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

For further information, please contact the responsible party or parallel importer.
Responsible party in Portugal, 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
Portugal, country of export, marketing authorisation number: 4041786
Parallel import authorisation number: 144/24
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
This medicinal product is authorised for sale 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