OFTALMOLOSA CUSI CHLORAMPHENICOL 10 mg/g OPHTHALMIC OINTMENT

Introduction

Package Leaflet: Information for the User

OFTALMOLOSA CUSÍ CHLORAMPHENICOL 10 mg/g Ophthalmic Ointment

Read the entire package leaflet carefully before starting to use the medicine, 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 medicine 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What OFTALMOLOSA CUSÍ CHLORAMPHENICOL is and what it is used for
2. What you need to know before starting to use OFTALMOLOSA CUSÍ CHLORAMPHENICOL
3. How to use OFTALMOLOSA CUSÍ CHLORAMPHENICOL
4. Possible side effects
5. 5. Storage of OFTALMOLOSA CUSÍ CHLORAMPHENICOL
6. Package Contents and Additional Information

1. What OFTALMOLOSA CUSÍ CHLORAMPHENICOL is and what it is used for

OFTALMOLOSA CUSÍ CHLORAMPHENICOL is an ophthalmic ointment that contains an active substance (chloramphenicol) which is a broad-spectrum antibiotic, with bacteriostatic action, that acts by inhibiting bacterial protein synthesis.

This medicine is indicated in adults and children to treat infections of the anterior segment of the eye (conjunctiva and/or cornea) caused by microorganisms sensitive to chloramphenicol. In cases of severe infections, application to the eye should be complemented with systemic administration of an appropriate antibiotic.

2. What you need to know before starting to use OFTALMOLOSA CUSÍ CHLORAMPHENICOL

Do not use OFTALMOLOSA CUSÍ CHLORAMPHENICOL

• If you are allergic to chloramphenicol or any of the other components of this medicine (listed in section 6).
• If you have ever had problems with bone marrow or blood abnormalities.
• If you have minor infections, for preventive treatments, or if you can use other antibiotics. This medicine is reserved for the treatment of more severe infections.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use OFTALMOLOSA CUSÍ CHLORAMPHENICOL.

• Use this medicine only in the eye(s).
• Systemic use of chloramphenicol can occasionally cause blood toxicity, but this rarely occurs with topical administration (see section 4. Possible side effects).
• Do not administer this medicine to premature and full-term infants with immature metabolism without consulting a doctor, as they may be more susceptible to experiencing severe adverse reactions.
• If you have liver or kidney problems, consult your doctor before using this medicine, as you may be more susceptible to experiencing severe adverse reactions (see section 4. Possible side effects).
• Use this medicine for the duration prescribed by your doctor.
• If you experience allergic reactions, such as skin rash, hives, fever, or swelling of the throat, tongue, or face, discontinue treatment immediately and consult your doctor.
• If your symptoms worsen or recur, consult your doctor.

If you use this medicine, especially for a long period, you may become more susceptible to other infections.

Other Medicines and OFTALMOLOSA CUSÍ CHLORAMPHENICOL

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

Do not use this medicine with other medicines that may cause bone marrow disorders.

Do not use this medicine with other ophthalmic medicines that contain another antibiotic or a sulfonamide. Do not use this medicine with bactericidal antibiotics due to the possibility of incompatibility.

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.

Do not use this medicine during pregnancy or breastfeeding.

Driving and Using Machines

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

3. How to Use OFTALMOLOSA CUSÍ CHLORAMPHENICOL

Follow your doctor's instructions for administering this medicine exactly. Consult your doctor or pharmacist if you have any questions.

The recommended dose is:

Adults, including elderly patients

Generally, apply approximately 1 cm of ointment to the affected eye(s) every 3 hours, or more frequently during the first 48 hours, and the interval between applications can be increased later, always according to medical criteria. Treatment should continue for at least 48 hours after symptoms have disappeared.

Children

In newborns, a dose adjustment may be necessary due to reduced systemic elimination caused by immature metabolism and the risk of dose-related adverse effects. The maximum treatment duration is 10-14 days.

Usage Recommendations:

If you are using other ophthalmic medicines, wait at least 5 minutes between administering this ointment and other ophthalmic medicines. Ophthalmic ointments should be administered last.

If you use more OFTALMOLOSA CUSÍ CHLORAMPHENICOL than you should, you can eliminate it by washing your eyes with warm water. Do not apply more ointment until the next scheduled dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use OFTALMOLOSA CUSÍ CHLORAMPHENICOL, 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 the next dose of your regular regimen. Do notapply a double dose to make up for missed doses.

If you interrupt treatment with OFTALMOLOSA CUSÍ CHLORAMPHENICOL

It is essential that you complete the treatment cycle indicated by your doctor, even if you start to feel better after a few days. If you stop using this medicine too soon, it is possible that the infection has not been fully cured, and symptoms may recur or worsen. Additionally, antibiotic resistance (loss of effectiveness) may occur.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

The following adverse reactions have been observed with an unknown frequency (cannot be estimated from available data):

• Eye effects: eye and eyelid swelling.
• General adverse effects: allergy.

Chloramphenicol may cause a decrease in bone marrow cells. Although most cases of blood disorders associated with chloramphenicol were after oral administration, it has also occurred with ophthalmic use (see section 2. Warnings and Precautions).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of OFTALMOLOSA CUSÍ CHLORAMPHENICOL

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

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

Do not store above 25°C.

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

Write the opening date 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 pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of OFTALMOLOSA CUSÍ CHLORAMPHENICOL

• The active ingredient is chloramphenicol. Each gram of ointment contains 10 mg of chloramphenicol.
• The other ingredients are cholesterol, liquid paraffin, and white petrolatum.

Appearance of the Product and Package Contents

OFTALMOLOSA CUSÍ CHLORAMPHENICOL is a white ointment presented in a 3g aluminum tube with a polyethylene cap.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

OmniVision GmbH

Lindberghstrasse 9

82178 Puchheim

Germany

Manufacturer

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

Local Representative

OmniVision Farma España S.L.

C/ Josep Irla i Bosch, 1-3

Pl: 6 Pt: 2

08034 Barcelona,

Spain

Date of the Last Revision of this Package Leaflet: November 2016

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