Oftacilox 3 mg/g ophthalmic ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OFTACILOX 3 mg/g eye ointment

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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What OFTACILOX ointment is and what it is used for

OFTACILOX ointment contains an antibiotic (ciprofloxacin) that belongs to a group of medicines 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 important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

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

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

2. What you need to know before using OFTACILOX ointment

Do not use OFTACILOX ointment

• If you are allergic to ciprofloxacin or to 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

Talk to 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 allergic reaction, including rash, itching, or breathing difficulties, 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 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 sensitivity to light has been observed with antibiotics. Similar reactions with ciprofloxacin are uncommon.

• If you experience pain, swelling, or inflammation of the tendons during or shortly after using this ointment, stop 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 any of the following situations, you may have an increased risk of 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 deposits (medication residues) have been observed in patients with corneal ulcers following frequent administration of this medicine. These deposits disappeared after continued application of the medicine. The deposits do not prevent continued use of this medicine and do not negatively affect the clinical course of recovery.

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

Using OFTACILOX ointment with other medicines

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

Using OFTACILOX ointment with food and drink

No effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 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 breast milk.

Driving and using machines

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

3. How to use OFTACILOX ointment

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

The recommended dose is:

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

Remember to apply your medicine when it is due.

Adults and children from 1 year of age

Apply a quantity of approximately 1 cm of ointment to the eye(s) 3 times a day for the first 2 days, then 2 times a day for the following 5 days.

OFTACILOX ointment is for ophthalmic use only, that is, as an ointment for the eyes.

Your doctor will advise you on the duration of your treatment with this medicine.

Instructions for use:

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

If you use more OFTACILOX ointment than you should, remove it by washing your eyes with lukewarm water. Do not apply more ointment until your next scheduled dose.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 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 then continue with your next scheduled dose. However, if it is almost time for your next dose, do not apply the missed dose and continue with your next dose as planned. Do not apply a double dose to make up for missed doses.

If you stop treatment with OFTACILOX ointment, do not discontinue using this medicine prematurely, even if symptoms have disappeared. If you stop using this medicine too early, symptoms may 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 ophthalmic ointment may produce 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), sensitivity to light, blurred or reduced vision, eyelid swelling, eye pain, dry eye, eye swelling, eye itching, abnormal sensation in the eye, increased tear production, eye discharge, eye crusting, eyelid peeling, 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 fatigue, eye inflammation, eye irritation, stye.
General effects: nasal inflammation, nasal discharge (runny nose), allergy, dizziness, ear pain, diarrhea, abdominal pain, skin inflammation, drug intolerance, abnormal laboratory test results.

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 via 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 ointment

Keep this medicine out of sight and reach of children.

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

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

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

Record the date of first opening of the tube in the space provided for this purpose on the carton.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the package and other information

Composition of OFTACILOX ointment

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

Appearance of the product and contents of the container

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

Marketing Authorization Holder

NTC s.r.l.,

via Luigi Razza 3,

20124 Milan, Italy

Manufacturer Responsible

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

Further information on 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 review of this leaflet: October 2014

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