Label: information for the user

OFTACILOX 3mg/g ophthalmic ointment

Ciprofloxacin

Read this label carefully before starting to use this medication, as 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 medication 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 is OFTACILOX ointment and what it is used for

2.What you need to know before starting to use OFTACILOX ointment

3.How to use OFTACILOX ointment

4.Possible adverse effects

5.Storage of OFTACILOX ointment

1. Contents of the package and additional information

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

This medication is indicated for the treatment of superficial eye infections and the surrounding areas (such as eyelids, etc.).

Do not use OFTACILOX ointment

• If you are allergic to ciprofloxacin or any of the other components 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 ointment.

• 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 suffer 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 ointment 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 ocular precipitates (residual medication) have been observed in patients with corneal ulcers and frequent administration of this medication, which disappeared after continuous application of this medication. 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 ointment with other medications

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

Use of OFTACILOX ointment with food and drinks

No influence.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe 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 ointment during pregnancy or breastfeeding, unless your doctor considers it necessary.

If you are breastfeeding your baby, do not use this ointment as it may pass into your breast milk.

Driving and operating machinery

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

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:

Follow these instructions unless your doctor has given you different instructions.

Remember to apply your medication when it is due.

Adultsand children from 1 year old

Apply an amount of approximately1 cmof ointment in the eye(s) 3 times a day for the first 2 days, then 2 times a day for 5 more days.

OFTACILOX ointment should only be used topically, i.e., as an eye ointment.

Your doctor will indicate the duration of your treatment with this medication.

Usage recommendations:

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

If you use more OFTACILOX ointment than you should,, you can remove it by washing your eyes with warm water. Do not apply more ointment 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 forgot to use OFTACILOX ointment,apply it as soon as you rememberandcontinue with the next dose that was 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 ointment,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 reappear.

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

Like all medications, OFTACILOX ointment 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 to1in every 10people)

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

General effects: bad taste.

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

Eye effects: injury or spots on the eye surface (cornea), light sensitivity, blurry 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 every 1,000people)

Eye effects: eye injury, corneal disorder, double vision, decreased perception of stimuli in the eye, 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 tube and on the box after CAD. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze. Do not store at a temperature above25°C.

To prevent infections, discard the tube 4 weeks after first opening it.

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

Medicines should not be thrown down the drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of OFTACILOX ointment

• The active ingredient is ciprofloxacin. Each gram of ointment contains 3mg of ciprofloxacin (as hydrochloride).
• The other components are liquid paraffin and white vaseline.

Appearance of the product and contents of the packaging

OFTACILOX ointment is a sterile ointment presented in tubes of 3.5g.

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

Or

S.A. ALCON-COUVREUR N.V.

Rijksweg, 14

Puurs B-2870 Belgium

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

NTC Ophthalmics Iberica SL,

Calle Pinar, 5,

28006 Madrid, Spain

Date of the last review of this leaflet: October 2014

The detailed and updated information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/