Label: information for the user

OFTACILOX 3mg/ml eye drop solution

Ciprofloxacin

Read this label carefully before starting to usethismedicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

2.What you need to know before starting to use OFTACILOX eye drop

3.How to use OFTACILOX eye drop

4.Possible adverse effects

5.Storage of OFTACILOX eye drop

1. Contents of the package and additional information

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

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

Do not use OFTACILOX eye drops

• If you are allergic to ciprofloxacin or any of the other ingredients in 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.

• Only use this medication in your eye(s).

• If you experience the first signs of a skin rash or any other hypersensitivity reaction, including itching, hives, or respiratory problems, stop treatment and consult your doctor immediately. If you have 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 sensitive to other infections, especially after using it for a long period of time.
• If you are an elderly person or are using medications called corticosteroids that are used to treat conditions such as pain and inflammation, asthma, or skin problems, then you have a higher risk of developing tendon problems during treatment with this medication. If you experience any inflammation or inflammatory condition, stop treatment and consult your doctor immediately.
• If you experience a skin reaction, consult your doctor. Sensitivity to light has been observed with antibiotics. Similar reactions with ciprofloxacin are rare.
• If during or shortly after using this eye drop you feel pain, swelling, or inflammation of the tendons, stop treatment and consult your doctor.
• Only use this medication in children under 1 year if strictly indicated by your doctor.
• If you are in one of these situations, you may have a higher risk of developing tendon problems:

• Advanced age.
• Treatment with steroids.
• • If you wear contact lenses:

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

• White precipitates 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, nor does it 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.

Use of OFTACILOX eye drops with other medications

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

The use of this medication is incompatible with alkaline solutions.

Use of OFTACILOX eye drops with food and drinks

No influence.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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 your baby, do not use this eye drop as it may pass into breast milk.

Driving and operating machines

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

OFTACILOX contains benzalkonium chloride

This medication may cause eye irritation because it contains benzalkonium chloride.

Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. Alters the color of soft contact lenses.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults, newborns, children, and adolescents

Corneal abscesses:

OFTACILOX eye drops should be administered according to the following intervals, even at 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 necessary, continue treatment with this medication after the 14th day, your doctor will indicate the administration frequency.

Other eye infections (purulent bacterial 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, instill one or two drops every 4 hours during the day. Your doctor will indicate the duration of treatment.

This product should not be used for more than 21 days, unless your doctor has given you other instructions.

Usage recommendations:

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To apply OFTACILOX eye drops correctly, follow the steps indicated:

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 cap.
4. Hold the bottle, upside down, between your thumb and the rest of your fingers (figure 1).
5. Incline your head back. Gently separate your eyelid from your eye with a finger until a pouch forms between your eyelid and your eye, where the drop should fall (figure 2).
6. Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
7. Do not touch your eye or eyelid, nearby areas, or other surfaces with the dropper. The drops could become contaminated.
8. Press gently on 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 the edge of your eye near your nose with your finger. This helps prevent the eye drops from spreading to the rest of your body (figure 4).
10. If you apply drops to both eyes, repeat all the previous steps for the other eye.
11. Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

When using other eye medications, wait at least 5 minutes between administering this eye drop and the other eye medications. Eye ointments should be administered last.

If you use more OFTACILOX eye drops than you should,you can remove them 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 Toxicological Information Service, phone91 562 04 20indicating 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 dose scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen.Do notapply a double dose to compensate for the missed doses.

If you interrupt treatment with 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.

Like all medications, OFTACILOX eye drops may cause adverse effects, although not everyone will experience them.

Adverse effects that may appear after use in the eye:

Common adverse effects (may affect up to1 in 10people)

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

General effects: bad taste.

Less common adverse effects (may affect up to1in 100people)

Eye effects: injury or spots on the eye surface (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, crust on the eye, eyelid peeling, eyelid redness.

General effects: nausea, headache.

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

Eye effects: eye injury, corneal disorder, double vision, decreased perception of eye stimuli, tired eyes, eye inflammation, eye irritation, sty.

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

Unknown frequency (cannot be estimated from available data):

General adverse effects: tendon disorder.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. 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 prevent infections, discard the bottle 4 weeks after it has been opened for the first time.

Note the date of opening the bottle in the reserved box for this purpose.

Medications should not be thrown away through drains or in the trash. Deposit the containers and medications you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need.By doing so, you will help protect the environment.

Composition of OFTACILOX eye drops

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

Appearance of the product and contents of the packaging

OFTACILOX eye drops are a solution in eye drops that are presented in 5 ml plastic bottles with a stopper.

Marketing authorization holder

NTC s.r.l.,

via Luigi Razza 3,

20124 Milan, Italy

Responsible for manufacturing

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

O

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

Last review date of this leaflet: October 2014

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/