Levoftial

Package Leaflet: Information for the User

Levoftyal, 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.
• 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.

Table of Contents of the Package Leaflet

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

1. What is Levoftyal and what is it used for

Levofloxacin is an antibiotic belonging to the group of fluoroquinolones (sometimes shortened to quinolones). The action of the medicine involves destroying certain types of bacteria that can cause infections.
Levofloxacin in the form of eye drops is used in children from 1 year of age and older, as well as in 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 part of the eye (conjunctiva).
It is not recommended to use Levoftyal in children under 1 year of age.
If after 5 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using Levoftyal

When not to use Levoftyal:

• 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 doubts, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use Levoftyal, discuss it with your doctor, pharmacist, or nurse:

• if an allergic reaction occurs, even after a single dose, discontinue use of the medicine,
• if during treatment the patient observes worsening of eye symptoms, they should contact their doctor as soon as possible,
• if after a certain period of treatment, established by the doctor, there are no signs of improvement, the patient should contact their doctor as soon as possible,
• in general, during eye infections, contact lenses should not be worn,
• Levoftyal contains a preservative, benzalkonium chloride, which may cause eye irritation.

In patients taking fluoroquinolones orally or intravenously, especially in elderly patients and those treated with corticosteroids at the same time, tendon swelling and rupture have been observed. If tendon pain or inflammation (tendinitis) occurs, discontinue use of Levoftyal.

Children and adolescents

Special warnings and precautions for using this medicine are the same for adults, adolescents, and children from 1 year of age and older.

Levoftyal and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
It is especially important to tell your doctor or pharmacist about using any other eye drops or ointments before starting to use Levoftyal eye drops.
If you are using other eye drops, wait at least 15 minutes between using Levoftyal and other eye drops.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Levoftyal eye drops may be used in pregnant women only if the expected benefit justifies the potential risk to the fetus.
Breastfeeding
Although levofloxacin penetrates into the blood and breast milk in very small amounts after administration of eye drops, it is very unlikely to harm the developing child. The doctor is aware of the potential risks and will advise whether to use Levoftyal in such a situation.
Fertility
When using Levoftyal according to the recommendations, fertility (the ability to become pregnant in women or have offspring in men) is not impaired.

Driving and using machines

Levoftyal has a minor 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.

Levoftyal contains benzalkonium chloride

This medicine contains 0.05 mg of benzalkonium chloride in 1 mL of solution.
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 related to 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, consult a doctor.

3. How to use Levoftyal

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Levoftyal is 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 to two drops into the infected eye(s) every two hours, up to eight times a day, except during sleep.

DAYS 3-5

• One to two drops into the infected eye(s) four times a day.

No dose adjustment is necessary in 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 using different types of eye drops.

Patients wearing contact lenses

If the patient wears contact lenses, they should be removed before using Levoftyal. After using Levoftyal, wait at least 15 minutes before putting the contact lenses back in.

Use in children and adolescents

No dose adjustment is necessary in children from 1 year of age and older and adolescents. It is not recommended to use Levoftyal in children under 1 year of age.

Instructions for use

• 1. Wash your hands and sit or stand in a comfortable position.
• 2. Unscrew the cap from the bottle.

• 3. Hold the inverted bottle between your thumb and other fingers.
• 4. Gently pull down the lower eyelid of the affected eye.

• 5. Bring the tip of the bottle close to the eye. Do not touch the tip of the bottle to the eye or the surrounding area.
• 6. Gently squeeze the bottle until one drop of medicine falls into the eye, then release the lower eyelid.

• 7. Press the inner corner of the affected eye near the nose with your finger and hold for 1 minute, keeping the eye closed.

• 8. Immediately after use, tightly close the bottle with the cap.

If it is necessary to administer another drop, or if the treatment also involves the other eye, repeat the steps described in points 3 to 8.
Levoftyal must not be injected into the inner part of the eyeball.

Using more Levoftyal than recommended

In case of using more Levoftyal than recommended, rinse the eye(s) with water and consult a doctor or pharmacist.

Missing a dose of Levoftyal

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

Accidental ingestion of Levoftyal

The amount of levofloxacin in the bottle is too small to cause side effects. However, in case of doubts, inform a doctor or pharmacist, who will advise on the necessary actions.

Stopping use of Levoftyal earlier than recommended by the doctor

Stopping the use of the drops earlier than recommended by the doctor may prolong the recovery process.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Levoftyal can cause side effects, although not everybody gets them.
Side effects occur in about one in ten people using Levoftyal.
Most of these side effects affect only the eye and usually do not last long. If the patient experiences any severe or prolonged side effects, they should discontinue use of the eye drops and urgently consult a doctor.
In very rare cases, the medicine may cause severe allergic reactions.
The following symptoms may occur even after a single dose of Levoftyal:

• swelling and feeling of pressure in the throat,
• difficulty breathing.

In rare cases, other allergic reactions may occur. Their symptoms include:

• worsening of eye redness and itching,
• worsening or sudden onset of eyelid swelling.

If any of these symptoms occur, discontinue use of Levoftyal and contact a doctor immediately.

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

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

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

• eye stinging or irritation,
• eye pain,
• eye dryness or discomfort,
• swelling or redness (inflamed eyes) of the conjunctiva (the front layer covering the eye) or eyelids,
• increased sensitivity to light,
• eye itching,
• eyelid stickiness,
• headache,
• rash around the eyes,
• nasal congestion or discharge.

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

• allergic reactions, such as skin rash.

Very rare side effects (may affect up to 1 in 10,000 people):

• swelling and feeling of pressure in the throat,
• difficulty breathing.

Additional side effects in children and adolescents

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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 Levoftyal

Keep the medicine out of the sight and reach of children.
Do not store in the refrigerator or freeze. Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the label and carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
Do not use the medicine if, before starting to use a new bottle, the patient notices that the plastic seal around the cap and neck of the bottle has been broken or damaged.
Keep the bottle tightly closed.
After first opening: store below 25°C.
Shelf life after first opening the bottle: 28 days.
Medicines should 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 Levoftyal contains

• The active substance is levofloxacin. One mL of eye drops, solution, contains 5.12 mg of levofloxacin hemihydrate, equivalent to 5 mg of levofloxacin.
• The other ingredients are: benzalkonium chloride (preservative), sodium chloride, hydrochloric acid (to adjust pH), and water for injections.

What Levoftyal looks like and contents of the pack

Levoftyal is a clear, greenish-yellow solution, practically free from particles.
The medicine is supplied in a 5 mL white, opaque LDPE bottle with a dropper made of LDPE, and a PP cap with a PE tamper-evident seal.
The plastic bottle is packaged in a cardboard box.
Pack size: 1 bottle x 5 mL.

Marketing authorization holder and manufacturer

UNIMED PHARMA spol. s r.o.
Oriešková 11
82105 Bratislava
Slovakia
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Verco S.A.
Skwer kard. S. Wyszyńskiego 5, lok. 6U
01-015 Warsaw
Phone: +48 22 811 41 61

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

Estonia: Levofloxacin UNIMED PHARMA
Lithuania: Levofloxacin UNIMED PHARMA 5 mg/mL akinių lašai (tirpalas)
Latvia: Levofloxacin UNIMED PHARMA 5 mg/mL acu pilieni, šķīdums
Poland: Levoftyal
Slovenia: Levofloksacin UNIMED PHARMA 5 mg/mL kapljice za oko, raztopina
Hungary: Levofloxacin UNIMED PHARMA 5 mg/mL oldatos szemcsepp

Date of last revision of the package leaflet: