Ciloxan

Package Leaflet: Information for the Patient

Ciloxan, 3 mg/ml, Eye Drops, Solution

(Ciprofloxacin)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this 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.
• The medicine may harm others, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 infections (of the eyes) and surrounding tissues.
Ciloxan belongs to a group of medicines used in infections. It contains ciprofloxacin - a medicine from the quinolone group, which is active against many species of microorganisms that can cause eye infections.

2. Important information before using Ciloxan

When not to use Ciloxan:

• If you are allergic (hypersensitive) to ciprofloxacin or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to other antibiotics called quinolones.

Warnings and precautions

• Ciloxan eye drops should only be used for the eyes.
• If your symptoms worsen or suddenly return, you should contact your doctor. With the use of this medicine (especially long-term), you may be more susceptible to other infections.
• If you experience the first symptoms of a skin rash or other hypersensitivity reaction, including chills, itching, breathing problems, throat or face swelling, you should discontinue treatment and contact your doctor immediately. In case of a severe allergic reaction, immediate emergency treatment may be necessary.
• If you experience pain, or swelling or inflammation of the tendons during or immediately after using this medicine, you should discontinue treatment and contact your doctor.
• If you are elderly or if you are also taking medicines called corticosteroids (used, among other things, to treat pain, inflammation, asthma, and skin diseases), you are more likely to have tendon problems with Ciloxan eye drops.

If you develop tendonitis or tendon disease, you should discontinue treatment and contact your doctor immediately.

• Avoid excessive exposure to sunlight due to the risk of photosensitivity reactions. If symptoms of photosensitivity occur, you should discontinue the use of the medicine and contact your doctor.
• If you are using other medicines, you should also read the section: "Ciloxan and other medicines".
• Do not wear contact lenses(hard or soft) while using Ciloxan. Patients who are allowed by their doctor to wear contact lenses must remove them before using Ciloxan eye drops and wait at least 15 minutes before putting the contact lenses back in.
• In patients with corneal ulcers using Ciloxan eye drops frequently, white drug residues have been observed, which disappeared during uninterrupted use of Ciloxan eye drops. The presence of sediment does not preclude the use of the medicine or adversely affect the treatment process.

Before starting to use Ciloxan eye drops, you should discuss it with your doctor or pharmacist.

Children and adolescents

Clinical experience with the use of Ciloxan in children under one year of age, especially in newborns, is limited.

Ciloxan and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
If you are also using other eye medicines, you should wait 5 minutes before administering each of them. If you are also using eye ointment, you should apply it last.

Ciloxan with food and drink

Food and drink do not affect the action of Ciloxan.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
You should not use Ciloxan during pregnancy or breastfeeding unless your doctor considers it necessary.

Driving and using machines

For some time after using Ciloxan, your vision may be blurred. You should not drive or operate machinery until your vision is clear.

Ciloxan contains benzalkonium chloride

The medicine contains 0.06 mg of benzalkonium chloride per milliliter (0.06 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. You should remove contact lenses before instilling the drops and wait at least 15 minutes before putting the contact lenses back in.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or pain in the eye after using the medicine, you should contact your doctor.

3. How to use Ciloxan

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The medicine is for use in the eye only.

Recommended dose:

In cases of corneal ulcers, Ciloxan must be administered at the following intervals, even at night:

• first day - the dose is two drops into the eye (eyes) every 15 minutes for the first six hours, and then two drops into the eye (eyes) every 30 minutes for the rest of the day.
• second day - the dose is two drops into the eye (eyes) every hour.
• from the third to the fourteenth day - the dose is two drops into the eye (eyes) every four hours.

In the case of superficial eye infections and surrounding tissues, the dose is one or two drops into the eye (eyes) every six hours.
In the case of severe infections, the dosage during the first two days may be one or two drops every two hours during waking hours.
Treatment usually lasts 7-14 days. You should use the medicine for as long as your doctor has prescribed. The treatment time for corneal ulcers may be longer than 14 days.
It is recommended to gently close the eyelid and tear duct after instillation. This can help reduce the systemic absorption of eye drops and their systemic effects.
If you are using other eye medicines, you should leave a 5-minute interval between administering the medicines. If you are also using eye ointment, you should apply it last.

Use in children and adolescents

Clinical experience with the use of Ciloxan in children under one year of age, especially in newborns, is limited.

Method of administration

To avoid infecting the dropper tip and solution, be careful not to touch the dropper tip to the eyelids, surrounding tissues, or any other surfaces.

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• 1. Prepare the Ciloxan eye drops bottle and a mirror.
• 2. Wash your hands.
• 3. Unscrew the cap.
• 4. If the protective collar becomes loose after removing the cap, it should be discarded before using the medicine.
• 5. Hold the bottle in your hand and turn it upside down, holding it with your thumb and middle finger (Figure 1).
• 6. Tilt your head back. With a clean finger, pull the lower eyelid down to form a "pocket"; the drop should fall into it (Figure 2).
• 7. Bring the dropper tip close to the eye. You can use a mirror to help.
• 8. Do not touch the dropper tip to the eye, eyelid, or surrounding tissues. This may cause infection.
• 9. To release a single drop of Ciloxan, gently squeeze the bottom of the bottle (Figure 3).
• 10. After using the eye drops, remove the finger that held the lower eyelid. After instillation, gently close your eyes and press the corner of your eye near your nose with your finger. This will help prevent the medicine from entering the rest of your body (Figure 4).
• 11. If you are using the drops in both eyes, you should repeat the above steps to instill the drops into the other eye.
• 12. Immediately after use, screw the cap back on the bottle.
• 13. Only use one bottle at a time.

If the drop does not get into the eye, try again.

Using more Ciloxan than recommended

In case of local overdose of Ciloxan, it can be rinsed out of the eye with lukewarm water.
In case of accidental ingestion of the medicine, you should contact your doctor. However, no serious complications are expected.

Missing a dose of Ciloxan

If you miss a dose, use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping the use of Ciloxan

Do not stop treatment too early, even if your symptoms have improved. Stopping the use of Ciloxan against your doctor's advice may cause the infection symptoms to return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ciloxan can cause side effects, although not everybody gets them.
If you experience the first symptoms of a skin rash or any other symptoms of hypersensitivity, you should stop using Ciloxan immediately and contact your doctor or the Emergency Department of the nearest hospital.
Side effects that may occur after using Ciloxan:
Common(may affect up to 1 in 10 people)
Eye symptoms: white deposits on the surface of the eye (in the cornea), eye discomfort, redness of the eyes.
Systemic symptoms: taste disturbances.
Uncommon(may affect up to 1 in 100 people)
Eye symptoms: damage or infiltrate on the surface of the eye (cornea), punctate keratitis, photophobia, decreased visual acuity or blurred vision, eye or eyelid swelling, eye pain, dry eye, eye itching, increased tearing, eye discharge, crusts on the eyelid margins, eyelid scaling, eyelid redness, conjunctival swelling.
Systemic symptoms: headaches, nausea.
Rare(may affect up to 1 in 1,000 people)
Eye symptoms: eye damage, eye inflammation or irritation, double vision, decreased corneal sensitivity, keratitis or conjunctivitis, hordeolum, decreased visual acuity.
Systemic symptoms: hypersensitivity, dizziness, ear pain, nasal inflammation, increased nasal discharge, diarrhea, abdominal pain, skin inflammation.

Frequency not known (cannot be estimated from the available data):

Systemic symptoms: tendon disorders.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, 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. By reporting side effects, you can help provide more information on the safety of this 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 infection of the drops, the bottle should be discarded 4 weeks after first opening.You should write the date of opening on the space 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 that 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 pack 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 the pH, purified water.

What Ciloxan looks like and contents of the pack

Ciloxan is a liquid (clear, colorless or pale yellow solution) supplied in a 5 ml plastic bottle.
Packaging: 1 bottle of 5 ml.

Marketing authorization holder

Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
tel. +48 22 37 54 888

Manufacturer/Importer

Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Siegfried El Masnou, S.A.
Camil Fabra,58
El Masnou, 08320
Barcelona
Spain
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Date of last revision of the leaflet: 10/2024