Oftaquix

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

OFTAQUIX

5 mg/ml, eye drops, solution

Levofloxacin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist or nurse.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is OFTAQUIX and what is it 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 is OFTAQUIX and what is it 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 can cause infections.
Levofloxacin in the form of eye drops is used in children over 1 year of age, adolescents, and adults to treat bacterial infections of the front surface of the eye.
One type of infection in this area is bacterial conjunctivitis, which is an infection of the membrane covering the front part of the eye (conjunctiva).
OFTAQUIX should not be used in children under 1 year of age.
If there is no improvement or the patient feels worse after 5 days, they should consult a doctor.

2. Important information before using OFTAQUIX

When not to use OFTAQUIX:

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

In case of doubts, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before starting to use OFTAQUIX, the patient should discuss it with their doctor, pharmacist, or nurse

• if allergic reactions occur even after a single dose, the patient should stop using the medicine
• if the patient observes worsening of eye symptoms during treatment, they should contact their doctor immediately
• if after a certain period of treatment established by the doctor there are no signs of improvement, the patient should contact their doctor immediately
• as a rule, the patient should not wear any type of contact lenses during an eye infection.
• OFTAQUIX contains a preservative - benzalkonium chloride, which may cause eye irritation (see below for more information).

Swelling and tendon rupture have occurred in people taking fluoroquinolones orally or intravenously, especially in older patients and those treated with corticosteroids at the same time. The patient should stop using OFTAQUIX if they experience pain or swelling of the tendon (tendinitis).

Children and adolescents

The special warnings and precautions for using the medicine are the same for adults, adolescents, and children over 1 year of age.

OFTAQUIX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to use. In particular, the patient should tell their doctor or pharmacist if they are using any other eye drops or ointments before starting to use OFTAQUIX.
If the patient is using other eye drops, they should wait at least 15 minutes between administering OFTAQUIX and other eye drops.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
OFTAQUIX may be used in pregnant women only if the expected benefit outweighs the potential risk to the fetus.
Levofloxacin is excreted in very small amounts into the blood and breast milk after using eye drops; the likelihood of harming the developing child is very small. The doctor is informed about the potential risk and will advise the patient whether to use OFTAQUIX eye drops in such a situation.
OFTAQUIX may be used during breastfeeding only if the expected benefit outweighs the potential risk to the child.
When using OFTAQUIX according to the recommendations, fertility (the ability to become pregnant or father a child) is not affected.

Driving and using machines

OFTAQUIX has a negligible effect on the ability to drive and use machines. If the eye drops cause blurred vision, the patient should wait until their vision is clear before driving or operating machines.

OFTAQUIX contains benzalkonium chloride

This medicine contains about 0.002 mg of benzalkonium chloride per drop, which corresponds to 0.05 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before administering the drops and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or disorders affecting the cornea (the transparent layer on the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.

3. How to use OFTAQUIX

This medicine should always be used exactly as the doctor or pharmacist has told the patient. If the patient is not sure, they should ask their doctor or pharmacist.
OFTAQUIX eye drops are for use in the eye and must be applied to the outer surface of the eye.
For patients over 1 year of age, the recommended dose is:

DAYS 1-2

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

DAYS 3-5

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

For elderly patients, modification of the recommended dose is not necessary.
Treatment usually lasts for five days. The doctor will inform the patient how long they should use the drops.
If the patient is using any other eye medicine, they should wait at least 15 minutes between administering different types of eye drops.

Use in children and adolescents

There is no need to modify the dose in children over 1 year of age and adolescents.
OFTAQUIX should not be used in children under 1 year of age.

Before administering the drops:

If possible, the patient should ask another person to administer the drops. Before administering the drops, the patient should ask this person to read these instructions.

• 1) Wash your hands.
• 2) Open the bottle. Be careful not to touch the tip of the dropper to the eye or the surrounding areas or fingers.

3) Tilt your head back, hold the bottle upside down over the eye.

4) Pull the lower eyelid down and look up. Gently squeeze the container to release a single drop into the space between the lower eyelid and the eye.
5) Close your eye and press the inner corner of your eye with your finger for about one minute. This will prevent the drop from draining through the tear duct.

• 6) Wipe away any excess solution from the skin around the eyes.
• 7) Put the cap back on the bottle and close it tightly.

If it is necessary to administer another drop, or if both eyes are being treated, the patient should repeat the steps from 3 to 7.
OFTAQUIX eye drops should not be injected into the inner part of the eyeball.

Using more OFTAQUIX than recommended:

In case of using more than the recommended dose, the patient should rinse their eye(s) with clean water and inform their doctor or pharmacist.

Missing a dose of OFTAQUIX:

If the patient misses a dose of eye drops, they should use the next dose as soon as they remember. The patient should not use a double dose to make up for a missed dose.

Accidentally swallowing the eye drops:

The amount of levofloxacin in the bottle is too small to cause side effects. However, if the patient is unsure, they should inform their doctor or pharmacist, who will advise on the necessary measures.

Stopping the use of OFTAQUIX eye drops before the doctor recommended

may prolong the treatment process.
In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, OFTAQUIX can cause side effects, although not everybody gets them. They occur in about one in ten people using OFTAQUIX. Most of these side effects only affect the eye and may not last long. If the patient experiences any serious or prolonged side effects, they should stop using OFTAQUIX and seek urgent medical advice.
There is a possibility of an allergic reaction to this medicine.

Rarely, the following allergic reactions may occur (may affect up to 1 in 1000 people):

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

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

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

If the patient experiences any of the above side effects, they should stop using OFTAQUIX and contact their doctor or the Emergency Department of the nearest hospital immediately.
Additionally, the following may occur:

Common side effects (may affect up to 1 in 10 people)

• eye burning sensation,
• worsening of vision or mucous discharge in the conjunctival sac.

Uncommon side effects (may affect up to 1 in 100 people):

• headache,
• eye burning or irritation,
• swelling or redness (red eyes) of the conjunctiva (the front layer covering the eye),
• rash around the eyes,
• eye itching,
• eye pain,
• eye dryness or discomfort,
• increased sensitivity to light,
• eyelid sticking together,
• stuffy nose or runny nose.

Rare side effects (may affect up to 1 in 1000 people):

• allergic reactions, such as skin rash.

Additional side effects in children and adolescents

It is expected that the frequency, type, and severity of side effects in children and adolescents are the same as in adults.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland. Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store OFTAQUIX

This medicine should be kept out of the 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 month. The abbreviations "Lot" and "Lote" mean batch number.
Do not use this medicine if the new bottle does not have a plastic foil around the neck and dropper or if it is damaged.

To prevent contamination of the drops, the bottle should be discarded after 28 days of first opening and a new bottle should be used.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 with a light yellow to light yellow-green color, without visible particles of solid substance.
• 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 more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the 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 by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, Marketing authorization number in Portugal, the country of export: 4041786

Parallel import authorization number: 144/24

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

This medicinal product is authorized under the name OFTAQUIX in the following Member States of the European Economic Area:
Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Poland, Portugal, Romania, Slovakia, Sweden, United Kingdom

Date of revision of the leaflet: 08.04.2024

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