OFTACILOX 3 mg/g OPHTHALMIC OINTMENT

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

Do not use OFTACILOX ointment

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use OFTACILOX ointment.

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

• If you experience the first signs of a skin rash or any other hypersensitivity reaction, including hives, itching, or breathing problems, discontinue treatment and consult your doctor immediately. If you suffer a severe allergic reaction, you may need emergency treatment.
• If your symptoms worsen or come back, consult your doctor. With the use of this medicine, you may become more sensitive to other infections, especially after using it for a long time.
• If you are an elderly person or are using medicines called corticosteroids used to treat conditions such as pain and inflammation, asthma, or skin problems, then you have a higher risk of tendon problems during treatment with this medicine. If you experience any inflammation or inflammatory condition, discontinue 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, discontinue treatment and consult your doctor.
• Use this medicine 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.
• Steroid treatment.
• • If you use contact lenses:

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

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

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

Using OFTACILOX ointment with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicine.

Using OFTACILOX ointment with food and drinks

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 medicine.

This medicine is not recommended during pregnancy. Do not use OFTACILOX ointment during pregnancy or breastfeeding, unless your doctor considers it necessary.

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

Driving and using machines

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

3. How to use OFTACILOX ointment

Follow exactly the administration instructions of this medicine 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 medicine when it is due.

Adultsand children from 1 year

Apply approximately 1 cm of ointment to 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 via the ophthalmic route, i.e., as an ointment for the eyes.

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

Recommendations for use:

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

If you use more OFTACILOX ointment than you should, you can eliminate it by washing your eyes with lukewarm water. Do not apply more ointment 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 medicine and the amount ingested.

If you forget to use OFTACILOX ointment, apply it 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 schedule. Do notapply a double dose to make up for missed doses.

If you stop using OFTACILOX ointment, do not stop using this medicine prematurely, even if the symptoms have disappeared. If you stop using this medicine too early, the symptoms may come back.

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

4. Possible side effects

Like all medicines, OFTACILOX ointment can cause side effects, although not everybody gets them.

Side effects that may appear 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, swelling of the eyelid, eye pain, dry eye, eye swelling, itching in the eye, abnormal sensation in the eye, increased tear production, eye discharge, crust on the eye, eyelid scaling, eyelid redness.

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 sensitivity to stimuli in the eye, tired eyes, 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 the available data):

General effects: tendon disorder.

Reporting of side effects

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

5. Storage of OFTACILOX ointment

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

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

Do not refrigerate or freeze. Do not store above 25°C.

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

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of OFTACILOX ointment

• The active substance is ciprofloxacin. Each gram of ointment contains 3 mg of ciprofloxacin (as hydrochloride).
• The other ingredients are liquid paraffin and white petrolatum.

Appearance of the product and contents of the pack

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

Marketing authorisation holder

NTC s.r.l.,

via Luigi Razza 3,

20124 Milan, Italy

Manufacturer

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 authorisation holder:

NTC Ophthalmics Iberica SL,

Calle Pinar, 5,

28006 Madrid, Spain

Date of last revision of this leaflet: October 2014

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