Oftaquix

Package Leaflet: Information for the User

Oftaquix, 5 mg/ml, eye drops, solution

Levofloxacin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist or nurse. See section 4.

Table of Contents of the Package 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 shortened to 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 one 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 outer layer of the front of the eye (conjunctiva).
Oftaquix should not be used in children under one year of age.
If there is no improvement or the patient feels worse after 5 days, the doctor should be consulted.

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 doubt, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use Oftaquix, the doctor, pharmacist, or nurse should be consulted

• if allergic reactions occur even after a single dose, the use of the medicine should be stopped
• if the patient observes worsening of eye symptoms during treatment, they should contact the doctor immediately
• if after a certain period of treatment set by the doctor, there are no signs of recovery, the doctor should be contacted immediately
• as a rule, 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 is provided below).

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.
Treatment with Oftaquix should be discontinued if pain or swelling of the tendon (tendinitis) occurs.

Children and adolescents

Special warnings and precautions for the use of the medicine are the same for adults, adolescents, and children over one year of age.

Oftaquix and other medicines

The patient should tell the 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 doctor or pharmacist should be informed about the use of 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 baby, they should consult a 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 administration of eye drops; the likelihood of causing harm to the developing child is very small.
The doctor will be 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 being breastfed.
When using Oftaquix according to the recommendations, fertility (the ability to become pregnant or father a child) is not impaired.

Driving and using machines

Oftaquix has a negligible influence 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 machinery.

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. Contact lenses should be removed before administering the drops and not put back for at least 15 minutes.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or disorders affecting the cornea (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, the doctor should be consulted.

3. How to use Oftaquix

This medicine should always be used exactly as the doctor or pharmacist has told you. If you are not sure, ask your 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 one 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.

No dose adjustment is necessary for elderly patients.
Treatment usually lasts for five days. The doctor will inform the patient how long to 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

No dose adjustment is necessary for children over one year of age and adolescents. Oftaquix should not be used in children under one year of age.

Before administering the drops:

If possible, ask another person to administer the drops. Before administering the drops to the patient, ask them 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 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 one drop into the space between the lower eyelid and the eye.
5) Close the eye and press the inner corner of the eye with your finger for about one minute. This helps prevent the drop from draining into the tear duct.

• 6) Wipe away any excess solution from the skin around the eyes.
• 7) Replace the cap and close the bottle.

If it is necessary to administer another drop, or if both eyes are being treated, 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 eye(s) should be flushed with clean water and the doctor or pharmacist should be informed.

Missing a dose of Oftaquix:

If a dose of eye drops is missed, the next dose should be administered as soon as possible. Do not use a double dose to make up for a missed dose.

Accidental ingestion of eye drops:

The amount of levofloxacin in the bottle is too small to cause side effects. However, in case of doubt, the doctor or pharmacist should be informed, who will recommend the necessary measures.
Stopping the use of Oftaquix eye drops, solution earlier than recommended by the doctormay prolong the treatment process.
In case of any further doubts about the use of this medicine, the doctor, pharmacist, or nurse should be consulted.

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 are only in the eye and may not last long. If the patient experiences any serious or prolonged side effect, they should stop using Oftaquix and seek urgent medical advice.
There is a possibility of developing 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 above side effects occur, the use of Oftaquix should be stopped and urgent medical advice should be sought.
In addition, 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 of side effects

If side effects occur, including any not listed in this leaflet, the doctor or pharmacist or nurse should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oftaquix

This medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of that month. The "Lot" abbreviation means 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.
Keep the container tightly closed.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Oftaquix contains

• The active substance is levofloxacin. 1 ml 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 the solid substance.
• The pack contains a white 5 ml solution bottle with a screw cap.

Marketing authorization holder and manufacturer

Marketing authorization holder

Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

Manufacturer

Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland

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 last revision of the leaflet: