OFTACILOX 3 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

OFTACILOX 3mg/ml eye drops solution

Ciprofloxacin

Read the entire package leaflet carefully before starting to usethismedication,as it contains important information for you.

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

Contents of the package leaflet:

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. Storage of OFTACILOX eye drops
   1. Package contents and additional information

1. What OFTACILOX eye drops are and what they are used for

OFTACILOX eye drops contain an antibiotic (ciprofloxacin) that belongs to a group of medications called fluoroquinolones, which acts against certain microorganisms that cause eye infections.

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

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

OFTACILOX eye drops are indicated for the treatment of corneal ulcers and superficial eye infections and surrounding areas (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 any other component of this medication (listed in section 6).
• If you are allergic to other antibiotics in the quinolone group.

Warnings and precautions

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

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

• If you experience the first signs of a skin rash or any other hypersensitivity reaction, including hives, itching, or respiratory problems, discontinue treatment and consult your doctor immediately. If you experience a severe allergic reaction, you may need emergency treatment.
• If your symptoms worsen or return, consult your doctor. With the use of this medication, you may become more susceptible to other infections, especially after using it for an extended period.
• If you are an elderly person or are using medications called corticosteroids, which are used to treat conditions such as pain and inflammation, asthma, or skin problems, you have a higher risk of tendon problems during treatment with this medication. If you experience any inflammation or inflammatory condition, discontinue treatment and consult your doctor immediately.
• If you experience a skin reaction, consult your doctor. Skin sensitivity to light has been observed with antibiotics. Similar reactions with ciprofloxacin are rare.
• If you experience pain, swelling, or inflammation of the tendons during or shortly after using this eye drop, discontinue treatment and consult your doctor.
• Use this medication in children under 1 year of age only if strictly indicated by your doctor.
• If you are in one of these situations, you may have a higher risk of tendon problems:

• Advanced age.
• Corticosteroid treatment.
• • If you wear contact lenses:

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

• White ocular precipitates (medication residues) have been observed in patients with corneal ulcers and after frequent administration of this medication, which disappeared after continuous application of this eye drop. The precipitate does not prevent continued use of this medication and does not negatively affect the clinical course of the recovery process.

Inform your doctor if you are or have been in the past in one of the above situations.

Using OFTACILOX eye drops with other medications

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medication.

The use of this medication is incompatible with alkaline solutions.

Using OFTACILOX eye drops with food and beverages

It has no influence.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended during pregnancy. Do not use OFTACILOX eye drops during pregnancy or breastfeeding, unless your doctor considers it necessary.

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

Driving and using machines

You may notice that your vision becomes blurry for a moment immediately after applying the eye drop. Do not drive or use machines until these effects have disappeared.

OFTACILOX contains 0.06 mg of benzalkonium chloride in each ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove contact lenses before using this medication and wait 15 minutes before putting them back.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medication.

3. How to use OFTACILOX eye drops

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults, newborns, children, and adolescents

Corneal abscesses:

OFTACILOX eye drops should be administered at the following intervals, even during the night:

• On the first day, instill two drops in the affected eye every 15 minutes for the first six hours, and then two drops every 30 minutes for the rest of the day.
• On the second day, instill two drops in the affected eye every hour.
• From the third day to the 14th, instill two drops in the affected eye every 4 hours. If it is necessary to continue treatment with this medication after the 14th day, your doctor will indicate the administration frequency.

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

For the first two days, instill one or two drops in the affected eye(s) every 2 hours during the day, and from the third day on, instill one or two drops every 4 hours during the day. Your doctor will indicate the treatment duration.

It is not recommended to use this product for more than 21 days, unless your doctor has given you different instructions.

Recommendations for use:

1 2 3 4

To correctly apply OFTACILOX eye drops, follow the indicated 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 ring from the seal.
4. Hold the bottle, upside down, between your thumb and the rest of your fingers (figure 1).
5. Tilt your head back. Gently separate the eyelid from the eye with a finger until a pocket forms between the eyelid and your eye, where the drop should fall (figure 2).
6. Bring the bottle tip close to the eye. You may find it helpful to use a mirror.
7. Do not touch the eye or eyelid, or nearby areas, with the dropper. The drops may 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 drop, press the edge of the eye near the nose with your finger. This helps prevent the eye drop from entering the rest of the body (figure 4).
10. If you are applying drops in both eyes, repeat all the previous steps with the other eye.
11. Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

If you are using other eye medications, wait at least 5 minutes between the administration of this eye drop and other eye medications. Ophthalmic ointments should be administered last.

If you use more OFTACILOX eye drops than you should, you can eliminate it by rinsing your eyes with warm water. Do not apply more drops until the next dose.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you stop using OFTACILOX eye drops, do not stop using this medication before time, even if the symptoms have disappeared. If you stop using this medication too soon, the symptoms may return.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, OFTACILOX eye drops can cause side effects, although not everyone experiences them.

Side effects that may occur after use in the eye:

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

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

General effects: bad taste.

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

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

General effects: nausea, headache.

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

Eye effects: eye injury, corneal disorder, double vision, decreased eye stimulation, tired vision, eye inflammation, eye irritation, hordeolum.

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

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

General side effects: tendon disorder.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of OFTACILOX eye drops

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle and carton after EXP. The expiration date is the last day of the month indicated.

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

To avoid infections, discard the bottle 4 weeks after opening it for the first time.

Write the opening date of the bottle in the space provided on the carton.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

OFTACILOX eye drops composition

• The active ingredient is ciprofloxacin. Each ml of solution contains 3 mg of ciprofloxacin (as hydrochloride).
• The other ingredients are benzalkonium chloride, disodium edetate, mannitol, 6N/1N acetic acid, sodium acetate trihydrate, hydrochloric acid, and/or sodium hydroxide (to adjust pH) and purified water/injectable water.

Appearance of the product and package contents

OFTACILOX eye drops are an eye drop solution presented in 5 ml plastic bottles with a cap.

Marketing authorization holder

NTC s.r.l.,

via Luigi Razza 3,

20124 Milan, Italy

Manufacturer

EXCELVISION S.A.

Rue de la Lombardière, 27

07100 Annonay

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

NTC Ophthalmics Iberica SL,

Calle Pinar, 5,

28006 Madrid, Spain

Date of the last revision of this package leaflet: June 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/