Oftacilox 3 mg/ml eye drops in solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

OFTACILOX 3mg/ml eye drops solution

Ciprofloxacin

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What OFTACILOX eye drops are and what they are used for
2. What you need to know before using OFTACILOX eye drops
3. How to use OFTACILOX eye drops
4. Possible side effects
5. How to store OFTACILOX eye drops
6. Contents of the pack and other information

1. What OFTACILOX eye drops is and what it is used for

OFTACILOX eye drops contains an antibiotic (ciprofloxacin) that belongs to a group of medicines called fluoroquinolones, which acts against certain microorganisms that cause infections in the eyes.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via the drain or in household waste.

OFTACILOX eye drops is indicated for the treatment of corneal ulcers and superficial infections of the eye and surrounding tissues (such as eyelids, etc.).

2. What you need to know before using OFTACILOX eye drops

Do not use OFTACILOX eye drops

• If you are allergic to ciprofloxacin or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other antibiotics belonging to the quinolone group.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use OFTACILOX eye drops.

• Use this medicine only in your eye(s).

• If you experience early signs of a skin rash or any other hypersensitivity reaction, including rash, itching, or breathing problems, stop treatment and contact your doctor immediately. If you have a severe allergic reaction, you may require emergency treatment.

• If your symptoms worsen or return, consult your doctor. With use of this medicine, you may become more susceptible to other infections, particularly after prolonged use.

• If you are elderly or are taking medicines called corticosteroids used to treat conditions such as pain and inflammation, asthma, or skin problems, you have an increased risk of tendon problems during treatment with this medicine. If you experience any swelling or inflammatory condition, stop treatment and contact your doctor immediately.

• If you develop a skin reaction, consult your doctor. Skin photosensitivity has been observed with antibiotics. Similar reactions with ciprofloxacin are uncommon.

• If you experience pain, swelling, or inflammation of tendons during or shortly after using this eye drop, stop treatment and consult your doctor.

• Use this medicine in children under 1 year of age only if strictly indicated by your doctor.

• You may have an increased risk of tendon problems if you are in any of the following situations:

• Advanced age.

• Treatment with steroids.

  • If you wear contact lenses:

• Wearing contact lenses (rigid or soft) is not recommended during treatment of an eye infection.

• White ocular deposits (medication residues) have been observed in patients with corneal ulcer and after frequent administration of this medicine, which disappeared after continued application of this eye drop. The deposits do not prevent continued use of this medicine, nor negatively affect the clinical course of recovery.

Inform your doctor if you are currently or have previously been in any of the above situations.

Using OFTACILOX eye drops with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The use of this medicine is incompatible with alkaline solutions.

Using OFTACILOX eye drops with food and drink

No effect.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is not recommended during pregnancy. Do not use OFTACILOX eye drops during pregnancy or breast-feeding unless your doctor considers it necessary.

If you are breast-feeding, do not use this eye drop as it may pass into breast milk.

Driving and using machines

You may notice blurred vision for a short time immediately after applying the eye drops. Do not drive or operate machinery until these effects have disappeared.

OFTACILOX contains 0.06 mg of benzalkonium chloride per ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the colour of contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause ocular irritation, particularly if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use OFTACILOX eye drops

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults, newborns, children, and adolescents

Corneal abscesses:

OFTACILOX eye drops should be administered according to the following schedule, including during the night:

• On the first day, instill two drops into the affected eye every 15 minutes for the first six hours, then two drops every 30 minutes for the remainder of the day.
• On the second day, instill two drops into the affected eye every hour.
• From day three to day 14, instill two drops into the affected eye every 4 hours. If continued treatment with this medicine is required beyond day 14, your doctor will instruct you on the frequency of administration.

Other eye infections (purulent bacterial conjunctivitis, corneal ulcers, and keratitis):

During the first two days, instill one or two drops into the affected eye(s) every 2 hours during the day. From the third day onward, instill one or two drops every 4 hours during the day. Your doctor will determine the duration of treatment.

Use of this product for longer than 21 days is not recommended unless your doctor has given you different instructions.

Instructions for use:

1 2 3 4

To correctly administer OFTACILOX eye drops, follow these steps:

1. Wash your hands.
2. Take the eye drop bottle and a mirror.
3. After opening the bottle for the first time, remove the plastic seal ring.
4. Hold the bottle upside down between your thumb and the other fingers (Figure 1).
5. Tilt your head backward. Gently pull down the eyelid to create a pouch between the eyelid and your eye, where the drop should fall (Figure 2).
6. Bring the tip of the bottle close to the eye. Using a mirror may be helpful.
7. Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip. The drops could become contaminated.
8. Gently squeeze the base of the bottle with your index finger to release one drop at a time (Figure 3).
9. After using the eye drops, press with your finger on the inner corner of the eye next to the nose. This helps prevent the eye drops from passing into the rest of the body (Figure 4).
10. If applying drops to both eyes, repeat all the previous steps for the other eye.
11. Close the bottle tightly immediately after use.

If a drop misses the eye, try again.

If you are using other ophthalmic medicines, wait at least 5 minutes between administering OFTACILOX eye drops and other eye medications. Ophthalmic ointments should be applied last.

If you use more OFTACILOX eye drops than you should, flush the eyes with lukewarm water. Do not administer additional drops until the next scheduled dose.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use OFTACILOX eye drops, administer a single dose as soon as you remember, and then continue with the next scheduled dose. However, if it is almost time for the next dose, do not administer the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed dose.

If you stop treatment with OFTACILOX eye drops, do not discontinue this medicine prematurely, even if symptoms have disappeared. Stopping treatment too early may cause symptoms to return.

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

4. Possible adverse effects

Like all medicines, OFTACILOX eye drops may cause adverse effects, although not everyone experiences them.

Adverse effects that may occur after use in the eye:

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

Eye effects: white deposits on the surface (cornea), discomfort, redness.

General effects: bad taste.

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

Eye effects: injury or spots on the surface of the eye (cornea), light sensitivity, blurred or reduced vision, eyelid swelling, eye pain, dry eye, eye swelling, eye itching, abnormal sensation in the eye, increased tear production, eye discharge, crusting of the eye, eyelid scaling, eyelid redness.

General effects: nausea, headache.

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

Eye effects: eye injury, corneal disorder, double vision, decreased perception of stimuli in the eye, eye strain, eye inflammation, eye irritation, stye.

General effects: inflammation inside the nose, runny nose (rhinorrhea), allergy, dizziness, ear pain, diarrhea, abdominal pain, skin inflammation, drug intolerance, abnormal laboratory test.

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

General adverse effects: tendon disorder.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of OFTACILOX eye drops

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle and the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions. Do not refrigerate or freeze.

To prevent infection, discard the bottle 4 weeks after first opening.

Record the date when the bottle was first opened in the space provided for this purpose on the carton.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of OFTACILOX eye drops

• The active substance is ciprofloxacin. Each ml of solution contains 3 mg of ciprofloxacin (as hydrochloride).
• The other components are benzalkonium chloride, disodium edetate, mannitol, 1N acetic acid, sodium acetate trihydrate, hydrochloric acid and/or sodium hydroxide (to adjust pH), and water for injections.

Appearance of the medicinal product and contents of the container

OFTACILOX eye drops is an eye drop solution supplied in 5 ml plastic bottles with a cap.

Marketing Authorization Holder

NTC s.r.l.,

via Luigi Razza 3,

20124 Milan, Italy

Manufacturer responsible for production

EXCELVISION S.A.

Rue de la Lombardière, 27

07100 Annonay

France

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder:

NTC Ophthalmics Iberica SL,

Calle Pinar, 5,

28006 Madrid, Spain

Date of the most recent revision of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/