Oftaquix sine

Patient Information Leaflet

Oftaquix sine, 5 mg/ml, eye drops, solution in single-dose container
Levofloxacinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• 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 share it with 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.

Table of contents:

1. What Oftaquix sine is and what it is used for
2. What you need to know 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 known as fluorochinolones (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 from 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).
The use of Oftaquix sine is not recommended in children under 1 year of age.
If there is no improvement or if your condition worsens after 5 days, consult your 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).

If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Oftaquix sine, discuss this with a doctor, pharmacist, or
nurse

• if allergic reactions occur, even after a single dose, discontinue use of the medicine immediately
• if during treatment the patient notices worsening of eye-related symptoms, they should contact a doctor immediately
• if after the treatment period prescribed by the doctor there are no signs of improvement, the patient should contact a doctor immediately
• in general, wearing any type of contact lenses should be avoided during eye infection.

Tendon swelling and tendon rupture have occurred in patients taking oral or intravenous
fluoroquinolones, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy.
Treatment with Oftaquix sine 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 older.
Oftaquix sine and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
In particular, inform the doctor or pharmacist about the use of any other eye drops or ointments before starting treatment with Oftaquix sine.
If the patient is using other eye drops, wait at least 15 minutes between administration of Oftaquix sine 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 a doctor or pharmacist before using this medicine.
Oftaquix sine 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; following 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 sine eye drops in such circumstances.
Oftaquix sine may be used during breastfeeding only if the expected benefit justifies the potential risk to the breastfed child.
When used according to recommendations, Oftaquix sine does not affect fertility (ability to become pregnant or father a child).
Driving and using machines
Oftaquix sine 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.

3. How to use Oftaquix sine

This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oftaquix sine eye drops are intended for ocular use and must be applied to the external surface of the eye.
For patients over 1 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 daily.

DAYS 3–5

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

Dose 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 be waited between applications of different eye drops.
Use in children and adolescents
There is no need for dose adjustment in children over 1 year of age and adolescents. Oftaquix sine is not recommended for use in children under 1 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 hands.
2. Tear open the foil pouch along the line.
3. Remove one single-dose container from the blister.
4. Place the remaining blister back into the pouch and fold the edge to close the pouch.

5) Ensure that the solution is in the bottom of the single-dose container.
6) Open the container by twisting off the top end.
7) Tilt the head backward while sitting or lying down. 8) Bring the container tip close to the eye.
9) Pull the lower eyelid downward and look upward. 10) Gently squeeze the container to release a single drop into the space between the lower eyelid and the eye.
11) Close the eye briefly. Press the index finger against the inner corner of the eye for about one minute. This helps prevent the drop from draining through the tear duct.

If an additional drop is required, and also when treatment involves the other eye,
repeat the steps described in steps 8 to 11.
Do not inject Oftaquix sine into the inner part of the eyeball.
For single use only. The eye drops should be used immediately after first opening the single-dose container.
The content of the single-dose container is sufficient to administer to both eyes.
The container with any remaining solution should be discarded after single use.
Use of a higher than recommended dose of Oftaquix sine
If a higher than recommended dose of Oftaquix sine is used, rinse the eye(s) with clean water and inform your doctor or pharmacist.
Missed dose of Oftaquix sine
If a dose of eye drops is missed, apply the next dose as soon as you remember. Do not use a double dose to make up for the missed dose.
Accidental swallowing of Oftaquix sine
The amount of levofloxacin contained in the single-dose container is too small to cause adverse effects. However, if in doubt, inform your doctor or pharmacist, who will advise on necessary measures.
Stopping the use of Oftaquix sine eye drops, solution earlier than prescribed by the doctor may prolong the treatment process.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Most of these adverse reactions are confined to the eye and may not last long. If a patient experiences any severe or persistent adverse reaction, treatment with Oftaquix sine should be discontinued 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 sine.
If any of the above adverse reactions occur, stop using Oftaquix sine immediately and contact a doctor or go to the Emergency Department of the nearest hospital without delay.

Additionally, the following may occur:

Frequent adverse reactions (may occur in up to 1 in 10 people):

• burning sensation in the eye,
• blurred vision or mucus discharge in the conjunctival sac.

Uncommon adverse reactions (may occur in 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 the eyelids,
• nasal congestion or runny nose.

Rare adverse reactions (may occur in 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide 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,
aluminum pouch, and carton after “EXP”. The expiry date refers to the last day of the specified month.
The abbreviation "Lot" indicates the batch number.
Store the containers below 25°C in the original packaging, protected from light.
After first opening the pouch, the single-dose containers may be stored in the original aluminum pouch for 3 months. After this period, all unused single-dose containers must be discarded.
The opened single-dose container with any remaining solution must be immediately discarded after first use.
Do not use this medicine if insoluble particles are visible in the solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Oftaquix sine contains

• The active substance is levofloxacin. 1 ml contains 5.12 mg of levofloxacin hemihydrate, equivalent to 5 mg of levofloxacin. Each single-dose container (0.3 ml) contains 1.5 mg of levofloxacin.
• Other ingredients 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, ranging from pale yellow to pale greenish-yellow, without visible solid particles.
• Single-dose containers are packed in blisters of ten units per laminated sachet. The sachets are packed into cardboard boxes.
• Each 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 types may be marketed.

Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland
This medicinal product is authorised for marketing in the European Economic Area under the following names:
Denmark, Finland, Iceland, Italy, Sweden: Oftaquix
Germany, Poland: Oftaquix sine
United Kingdom: Oftaquix Unit Dose