Oftaquix sine

Package Leaflet: Information for the User

Oftaquix sine, 5 mg/ml, eye drops, solution in a single-dose container
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, 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet:

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

1. What Oftaquix sine is and what it is 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 from 1 year, 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 sine should not be used in children under one 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 sine

When not to use Oftaquix sine

• if the patient is allergic to levofloxacin, 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 sine, discuss it with a doctor, pharmacist, or nurse

• if allergic reactions occur even after a single dose, the use of the medicine should be stopped
• if during treatment the patient observes worsening of eye symptoms, they should immediately contact a doctor
• if after a certain period of treatment established by the doctor there are no signs of recovery, the patient should immediately contact a doctor
• as a rule, no type of contact lenses should be worn during an eye infection.

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 sine 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 sine and other medicines

Tell a doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines planned to be used.
Particularly, tell a doctor or pharmacist about using any other eye drops or ointments before starting to use Oftaquix sine.
If the patient is using other eye drops, wait at least 15 minutes between administering Oftaquix sine 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 a doctor or pharmacist before using this medicine.
Oftaquix sine may be used in pregnant women only if the expected benefit outweighs the potential risk to the fetus.
Levofloxacin penetrates into the blood and breast milk of women in very small amounts; after using eye drops, the likelihood of harming the developing child is very low.
The doctor is informed about the potential risk and will advise the patient whether to use Oftaquix sine eye drops in such a situation.
Oftaquix sine may be used during breastfeeding only if the expected benefit outweighs the potential risk to the breastfed child.
When using Oftaquix sine according to the recommendations, fertility (the ability to become pregnant or father a child) is not impaired.

Driving and using machines

Oftaquix sine 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 machines.

3. How to use Oftaquix sine

This medicine should always be used exactly as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oftaquix sine eye drops are intended 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.

In elderly patients, modification of the recommended dose is not necessary.
Treatment usually lasts for five days. A doctor will inform the patient how long to use the drops.
If the patient is using any other eye medicine, 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 one year of age and adolescents. Oftaquix sine 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 to the patient.

• 1) Wash your hands.
• 2) Tear the foil sachet along the line.
• 3) Remove one single-dose container from the blister.
• 4) Place the remaining blister back in the sachet and fold the edge to close the sachet.

5) Make sure the solution is in the lower part of the single-dose container.
6) Open the container by twisting its upper end.
7) Tilt your head back while sitting or lying on your back. 8) Bring the tip of the container close to the eye.

9) Pull the lower eyelid down and look up. 10) Gently squeeze the container to release a single drop into the space between the lower eyelid and the eye.
11) Close your eye for a moment. Press the inner corner of your eye with your index finger for about one minute. This helps prevent the drop from draining through the tear duct.

If an additional drop is needed, or if both eyes are being treated, repeat the steps from 8 to 11.
Do not inject Oftaquix sine into the inner part of the eyeball.
For single use only. Use the eye drops immediately after opening the single-dose container.
The contents of the single-dose container are sufficient for both eyes.
Discard the single-dose container with the remaining solution after single use.

Using more Oftaquix sine than recommended

In case of using more Oftaquix sine than recommended, rinse the eye(s) with clean water and inform a doctor or pharmacist.

Missing a dose of Oftaquix sine

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

Accidentally swallowing Oftaquix sine

The amount of levofloxacin in the single-dose container is too small to cause side effects. However, in case of doubt, inform a doctor or pharmacist, who will recommend the necessary measures.
Stopping the use of Oftaquix sine eye drops, solution earlier than recommended by the doctormay prolong the treatment process.
In case of further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Oftaquix sine can cause side effects, although not everybody gets them.
Most of these side effects affect only the eye and may not last long. If the patient experiences any severe or prolonged side effects, they should stop using Oftaquix sine 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 it.

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

• swelling or constriction in the throat,
• difficulty breathing.

These symptoms may occur even after a single dose of Oftaquix sine.

In case of the above side effects, stop using Oftaquix sine and contact a doctor or the Emergency Department of the nearest hospital immediately

In addition, the following may occur:

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

• eye burning sensation,
• impairment of 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 (red eyes) of the conjunctiva (the front layer covering the eye),
• rash around the eyes,
• itching of the eyes,
• eye pain,
• dryness or discomfort of the eyes,
• increased sensitivity to light,
• stickiness of the eyelids,
• 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 side effects occur, including any not listed in this leaflet, tell a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Oftaquix sine

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the single-dose container, foil sachet, and carton after "EXP". The expiry date refers to the last day of that month.
The "Lot" abbreviation means batch number.
Containers should be stored in a temperature below 25°C in the original packaging, protected from light.
After opening the sachet, single-dose containers can be stored in the original sachet for 3 months. After this time, discard all unused single-dose containers.
An opened single-dose container with the remaining solution should be discarded immediately after the first use.
Do not use this medicine if there are visible particles in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask a 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 sine contains

• The active substance of the medicine is levofloxacin. 1 ml contains 5.12 mg of levofloxacin hemihydrate, equivalent to 5 mg of levofloxacin. One single-dose container (0.3 ml) contains 1.5 mg of levofloxacin.
• The other ingredients of the medicine are sodium chloride, sodium hydroxide or hydrochloric acid, and water for injections.

What Oftaquix sine looks like and contents of the pack

• Oftaquix sine is a clear solution with a light yellow to light yellow-green color, without visible particles.
• Single-dose containers in blisters are packed in foil sachets. The sachets are packed in cardboard boxes.
• One single-dose container contains 0.3 ml of solution.
• Pack sizes: 10 x 0.3 ml, 20 x 0.3 ml, 30 x 0.3 ml, and 60 x 0.3 ml. Not all pack sizes may be marketed.

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:
Denmark, Finland, Iceland, Italy, Sweden: Oftaquix
Germany, Poland: Oftaquix sine
United Kingdom: Oftaquix Unit Dose

Date of last revision of the leaflet: