Petas

Patient Information Leaflet

Petas 5 mg/ml eye drops, solution, 5 mg/ml eye drops, solution in single-dose container

Levofloxacin
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Petas is and what it is used for

Levofloxacin is an antibiotic belonging to the Fluoroquinolones class (also commonly referred to as Quinolones).
The antibiotic works by killing certain types of bacteria that can cause infections.
Levofloxacin in the form of eye drops is indicated for the treatment of bacterial infections affecting
the front surface of the eye in children aged 1 year and older, and in adults.
One type of infection in this part of the eye is bacterial conjunctivitis, an infection of the eye's
front covering (conjunctiva).
The use of Petas is not recommended in children under 1 year of age.
Consult your doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before using Petas

Do not use Petas
‐ if you are allergic to levofloxacin, to other quinolones, or to any of the other ingredients of this
medicinal product (listed in section 6).
If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Petas if:
‐ you experience an allergic reaction even after a single dose, do not use this medicine anymore;
‐ during treatment you notice worsening of eye symptoms, contact your doctor as soon as possible;
‐ you do not notice any improvement within the treatment period agreed with your doctor, contact your doctor as soon as possible;
‐ in general, the use of any type of contact lenses is not recommended while an eye infection is present.

Petas in the multidose formulation contains the preservative benzalkonium chloride, which may cause eye irritation. In such a case, you may use Petas in the single-dose formulation, which does not contain preservatives.

Swelling and rupture of tendons have occurred in people taking oral or intravenous fluorochinolones, particularly in elderly patients and in those being treated concomitantly with corticosteroids.
Discontinue treatment with Petas if you develop tendon pain or swelling (tendinitis).

Children and adolescents
Special warnings and precautions for use of this medicine are the same in adults, adolescents, and children aged 1 year and older.

Other medicines and Petas
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

In particular, inform your doctor or pharmacist if you are using any other type of eye drops or ophthalmic ointment before starting to use Petas.

If you are using other eye drops, wait at least 15 minutes between the application of Petas and any other eye drops.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Petas eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Although very small amounts of levofloxacin may pass into the bloodstream and breast milk following administration of the eye drops, it is very unlikely that the medicine could harm the baby.

Your doctor is aware of the potential risks and will advise you whether you can use Petas eye drops.

Your fertility (the ability to conceive or father a child) is not affected when applying Petas as directed.

Driving and using machines
Petas may slightly affect the ability to drive or use machinery.

If use of the eye drops causes blurred vision, wait until this effect has passed before driving or using machinery.

Petas “multidose bottle” contains benzalkonium chloride
This medicine contains 0.05 mg of benzalkonium chloride per ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If you experience an unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use Petas

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Petas eye drops are for ophthalmic use and must be applied to the external surface of the eye.

For patients over 1 year of age, the recommended dosage is as follows:

DAYS 1–2

• Apply one or two drops into the affected eye(s) every two hours.
• Apply a maximum of eight times per day.

DAYS 3–5

• Apply one or two drops into the affected eye(s).
• Apply a maximum of four times per day.

No dose adjustment is required in elderly patients.

The total duration of treatment is five days. Your doctor will advise you on how long you should use the eye drops.

If you are using any other eye medications, wait at least 15 minutes between each application of different eye drops.

Use in children and adolescents

No dosage adjustments are necessary in children aged 1 year and older and in adolescents.

The use of Petas is not recommended in children under 1 year of age.

Instructions for use

If possible, ask someone to help you apply the eye drops. Before applying the drops, ask the person assisting you to read these instructions together with you.

Use of the multidose bottle

1. Wash your hands.
   2) Open the bottle. Take particular care to avoid touching the tip of the bottle to the eye, the skin around the eyes, eyelashes, or fingers.
2. Tilt your head backwards and invert the bottle over the eye.
3. Pull down the lower eyelid and look upwards. Gently press the bottle to release one drop into the space between the lower eyelid and the eye.
4. Close the eye and press with a finger on the inner corner of the eye for about one minute. This helps prevent the eye drop from draining into the tear duct.
5. Wipe away any excess solution from the skin around the eye.
6. Replace the cap and close the bottle tightly.

If you need to apply another drop or treat both eyes, repeat steps 3 to 7.

Use of single-dose containers

1. Wash your hands.
2. Open the aluminum pouch containing the single-dose containers.
3. Remove one vial from the strip and store the remaining vials back in the aluminum pouch.
4. Open the container by removing the cap. Take particular care to avoid touching the tip of the container to the skin around the eyes, eyelashes, or fingers.
5. Sit with your head tilted backwards or lie down in a supine position.
6. Hold the tip of the vial close to the eye without touching it.
7. Pull down the lower eyelid and look upwards.
8. Gently press the container to release one drop into the space between the lower eyelid and the eye.
9. Close the eye and press with a finger on the inner corner of the eye for about one minute. This helps prevent the drop from draining into the tear duct.

If you need to apply another drop or treat both eyes, repeat steps 6 to 9.

Petas eye drops are for ophthalmic use only. Do not use this medicine for injections into the eyeball.

For single-dose containers only.

Use the eye drops immediately after first opening the single-dose container.

A single-dose container contains enough solution for both eyes.

After use, discard the container, including any remaining solution.

If you use more Petas than you should

If you use more Petas than recommended, rinse the eye(s) with water and consult your doctor or pharmacist.

If you forget to use Petas

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

If you accidentally swallow Petas

The amount of levofloxacin contained in either the multidose bottle or the single-dose containers is too small to cause adverse effects. However, if you are concerned, consult your doctor or pharmacist, who will advise you on any necessary measures.

If you have any doubts about how to use this product, consult your doctor or pharmacist.

If you stop using Petas before the recommended time, it may delay the healing process.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
In about 1 out of 10 people using Petas, a side effect occurs. Most side effects affect only the eye and do not last long. If you experience any severe or persistent side effect, stop using the eye drops and consult your doctor urgently.
Very rarely, this medicine may cause serious allergic reactions.
The following symptoms may occur even after applying just a single dose of Petas:

• swelling and tightness sensation in the throat
• difficulty breathing. In rare cases, other allergic reactions may occur. Symptoms of these reactions include:
• worsening of eye redness and itching
• increase or sudden onset of swelling of the eyelids.

If any of these symptoms occur, stop using Petas immediately and consult a doctor without delay.
The side effects that may occur with the use of Petas are:
Common (may affect up to 1 in 10 users):

• burning sensation in the eye
• blurred vision or mucus in the eye

Uncommon (may affect up to 1 in 100 users):

• stinging pain or eye irritation
• painful eyes
• dry or inflamed eyes
• swelling or redness (bloodshot eyes) of the conjunctiva (the front covering of the eye) or eyelids
• light sensitivity
• eye itching
• sticky eyelids
• headache
• skin rash around the eyes
• nasal congestion or runny nose

Rare (may affect up to 1 in 1,000 users):

• allergic reactions, e.g. skin rash

Very rare (may affect less than 1 in 10,000 users):

• swelling and tightness sensation in the throat
• difficulty breathing

Additional side effects in children and adolescents
The frequency, type, and severity of side effects in children and adolescents are expected to be the same as in adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Petas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "EXP.". The expiry date refers to the last day of that month.
Multi-dose bottle
Store the medicine in its original packaging to protect it from light.
After first opening the bottle, use the medicine within 28 days; after this period, discard the bottle and, if needed, use a new one.
Single-dose containers
The medicine does not contain preservatives: after opening a single-dose container, use the medicine immediately; if partially used, discard any remaining solution.
After first opening the aluminium sachet, use the medicine within three months; after this period, discard the medicine.
Store any remaining single-dose containers in the aluminium sachet to protect them from light. Do not use Petas eye drops, single-dose, if you notice insoluble particles in the solution.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Petas contains
The active substance is levofloxacin. 1 ml contains 5 mg of levofloxacin (equivalent to 5.12 mg of levofloxacin hemihydrate).
The other components are:
Multiple-dose vial of 5.0 ml
benzalkonium chloride, sodium chloride, hydrochloric acid, water for injections.
Single-dose containers of 0.5 ml
sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of Petas and the contents of the pack
Carton containing 1 dropper bottle in LDPE of 5.0 ml.
Carton containing 20 single-dose containers in LDPE of 0.5 ml divided into strips, enclosed in an aluminum sachet.

Marketing Authorization Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)

This leaflet was last approved on