Ciloxan

Package leaflet: Information for the patient

Ciloxan, 3 mg/ml, eye drops, solution
(Ciprofloxacinum)
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others.
• This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Ciloxan is and what it is used for

Ciloxan is used to treat corneal ulcers and superficial eye (ocular) infections and infections of the surrounding eye tissues.
Ciloxan belongs to a group of medicines used to treat infections. It contains ciprofloxacin, a member of the quinolone group of antibiotics, which are active against many species of microorganisms that can cause eye infections.

2. Important information before using Ciloxan

When not to use Ciloxan:

• If the patient is allergic (hypersensitive) to ciprofloxacin or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic (hypersensitive) to other antibiotics known as quinolones.

Warnings and precautions

• Ciloxan eye drops should be used for the eyes only.

• If symptoms worsen or suddenly return, contact your doctor. Due to the use of this medicine (especially long-term), there may be an increased susceptibility to other infections.

• If the first signs of a skin rash or other allergic reaction occur, including chills, itching, breathing difficulties, throat swelling or facial swelling, treatment should be stopped immediately and the patient should contact their doctor without delay. In the case of a severe allergic reaction, immediate emergency treatment may be necessary.

• If the patient experiences pain, swelling or inflammation of tendons during or immediately after using this medicine, treatment should be discontinued and the patient should contact their doctor.

• If the patient is elderly or is concurrently using medicines called corticosteroids (used, among others, to treat pain, inflammation, asthma and skin disorders), they are at higher risk of tendon problems associated with treatment with Ciloxan eye drops. If inflammation or a disease of inflammatory nature occurs, the patient should discontinue treatment and contact their doctor immediately.

• Avoid excessive exposure to sunlight due to the risk of photosensitivity reactions. If symptoms of photosensitivity occur, discontinue use of the medicine and contact your doctor.

• If the patient is using other medicines concurrently, please also read the section: "Ciloxan and other medicines".

• Contact lenses (hard or soft) must not be used during treatment with Ciloxan. Patients who have been permitted by their doctor to use contact lenses must remove them before applying Ciloxan eye drops and wait at least 15 minutes before reinserting the contact lenses.

• In patients with corneal ulceration using Ciloxan eye drops frequently, white deposits of the medicine have been observed, which disappear during continued uninterrupted use of Ciloxan eye drops. The presence of such deposits does not preclude the use of the medicine nor adversely affect the course of treatment.

Before starting treatment with Ciloxan eye drops, please discuss this with your doctor or pharmacist.
Children and adolescents
Clinical experience with use in children under one year of age, and especially in newborns, is limited.
Ciloxan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
If the patient is also using other eye medicines, they should wait at least 5 minutes before administering each one. If an eye ointment is also being used, it should be applied last.
Ciloxan with food and drink
Food and drink do not affect the action of Ciloxan.
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 her doctor or pharmacist before using this medicine.
Ciloxan should not be used during pregnancy or breastfeeding unless considered necessary by a doctor.
Driving and using machines
Vision may be blurred for a short time after using Ciloxan. Do not drive or operate machinery until clear vision returns.
Ciloxan contains benzalkonium chloride
The medicine contains 0.06 mg of benzalkonium chloride per millilitre (0.06 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses must be removed before instillation and at least 15 minutes should be waited before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging or pain in the eye occur after using the medicine, contact your doctor.

3. How to use Ciloxan

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
This medicine is for ocular use only.
Recommended dosage:
In cases of corneal ulcers, Ciloxan should be administered at the following intervals, including during nighttime hours:

• First day – two drops into the eye(s) every 15 minutes for the first six hours, then two drops into the eye(s) every 30 minutes for the remainder of the day.
• Second day – two drops into the eye(s) every hour.
• From the third to the fourteenth day – two drops into the eye(s) every four hours.

For superficial eye infections and surrounding tissues, the dosage is one or two drops into the eye(s) every six hours.
In severe infections, dosing during the first two days may be one or two drops every two hours while awake.
Treatment usually lasts 7–14 days. The medicine should be used for as long as your doctor has instructed. In cases of corneal ulcers, treatment may last longer than 14 days.
It is recommended to gently close the eyelid and nasolacrimal duct after instillation of the medicine. This helps reduce systemic absorption and systemic effects of ophthalmic medications.
If other eye medications are used simultaneously, a 5-minute interval should be maintained between the administration of each product. If an eye ointment is also used, it should be applied last.

Use in children and adolescents
Clinical experience with use in children under one year of age, especially in newborns, is limited.

Instructions for use
To prevent contamination of the dropper tip and solution, exercise caution and do not let the dropper tip touch the eyelids, surrounding tissues, or any surface.

1 2 3 4

1. Prepare the Ciloxan medicine bottle, eye drops, and a mirror.
2. Wash your hands.
3. Unscrew the cap.
4. If the safety collar becomes loose after removing the cap, discard it before using the medicine.
5. Hold the bottle in your hand with the bottom facing upward, using your thumb and middle finger (Fig. 1).
6. Tilt your head backward. Gently pull down the lower eyelid with a clean finger to form a "pouch"; the drop should be instilled into this pouch (Fig. 2).
7. Bring the dropper tip close to the eye. A mirror may be helpful.
8. Do not let the dropper touch the eye, eyelid, surrounding area, or any other surface. This may lead to contamination of the drops.
9. To release a single drop of Ciloxan, gently squeeze the base of the bottle (Fig. 3).
10. After instilling Ciloxan eye drops, remove the finger from the lower eyelid. Gently close the eyes and press with a finger on the inner corner of the eye near the nose for about one minute. This helps prevent the medicine from draining into the rest of the body (Fig. 4).
11. If drops are to be used in both eyes, repeat the above steps for the second eye.
12. Immediately after use, replace the cap on the bottle.
13. Only one bottle should be used at a time.

If the drop misses the eye, repeat the instillation procedure.

Accidental overdose of Ciloxan
In case of local overdose, the eye may be rinsed with lukewarm water.
If the medicine is accidentally swallowed, contact a doctor. However, serious complications are not expected.

Missed dose of Ciloxan
If a dose is missed, administer it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not double the dose to make up for a missed one.

Stopping Ciloxan treatment
Do not stop treatment too early, even if symptoms improve. Premature discontinuation of Ciloxan, contrary to medical advice, may result in recurrence of eye infection symptoms.

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

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
If the first signs of skin rash or any other symptoms of hypersensitivity occur, stop using Ciloxan immediately and contact your doctor or the nearest hospital's Emergency Department.

Adverse reactions that may occur after using the medicine:

Common (may occur in 1 to 10 out of 100 people)
Eye symptoms: white deposits on the surface of the eye (in the cornea), eye discomfort, redness of the eye.
General systemic symptoms: taste disturbances.

Uncommon (may occur in about 1 to 10 out of 1,000 people)
Eye symptoms: damage or infiltration on the surface of the eye (cornea), punctate keratitis, photophobia, decreased visual acuity or blurred vision, swelling of the eye or eyelid, eye pain, dry eye, eye itching, excessive tearing, eye discharge, crusts at the eyelid margins, eyelid desquamation, eyelid redness, conjunctival swelling.
General systemic symptoms: headache, nausea.

Rare (may occur in about 1 to 10 out of 10,000 people)
Eye symptoms: eye damage, inflammation or irritation of the eye, double vision, decreased eye sensitivity, keratitis or conjunctivitis, stye, reduced visual strength.
General systemic symptoms: hypersensitivity, dizziness, ear pain, nasal inflammation, increased nasal sinus secretion, diarrhoea, abdominal pain, skin inflammation.

Frequency unknown (cannot be estimated from available data):
General systemic symptoms: tendon disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ciloxan

Keep the medicine out of the sight and reach of children.
Do not store in the refrigerator or freeze.
Keep the bottle tightly closed.
To prevent contamination of the drops, the bottle must be discarded 4 weeks after first opening.
Enter the date of first opening in the space provided below.
Opened (date): …………….
Do not use this medicine after the expiry date (EXP) stated on the carton and bottle.
The expiry date refers to the last day of the stated month.
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 package and other information

What Ciloxan contains

• The active substance is ciprofloxacin 3 mg/ml (as hydrochloride)
• The other ingredients are: benzalkonium chloride, sodium acetate (trihydrate), acetic acid, mannitol, disodium edetate, sodium hydroxide and (or) hydrochloric acid (to adjust pH), purified water.

What Ciloxan looks like and contents of the pack
Ciloxan is a clear, colourless or slightly yellow solution supplied in a plastic bottle containing 5 ml, with a safety seal cap, packed in a cardboard box.
Marketing Authorisation Holder
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel. +48 22 37 54 888
Manufacturer/Importer
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain