Package Insert: Information for the User

CHLORAMPHENICOL EYE OINTMENT 10 mg/g

Read this package insert carefully before starting to use the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 package insert. See section 4.

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

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

Do not use OFTALMOLOSA CUSÍ CLORAMFENICOL

Warnings and precautions

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

• Use this medication only in the eye(s).
• The systemic use of chloramphenicol may occasionally cause blood toxicity, but rarely occurs with topical administration (see section 4. Possible adverse effects).
• Do not administer this medication to premature and full-term newborns 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 medication, as you may be more susceptible to experiencing severe adverse reactions (see section 4. Possible adverse effects).
• Use this medication for the time your doctor has prescribed.
• If you experience allergic reactions, such as skin rash, urticaria, fever, or swelling of the throat, tongue, or face, stop using the medication immediately and consult your doctor.
• If your symptoms worsen or return, consult your doctor.

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

Other medications and OFTALMOLOSA CUSÍ CLORAMFENICOL

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

Do not use this medication with other medications that may cause bone marrow disorders.

Do not use this medication with other eye medications that contain another antibiotic or a sulfonamide. Do not use this medication with bactericidal antibiotics due to the possibility of incompatibility.

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.

Do not use this medication during pregnancy or breastfeeding.

Driving and operating machines

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults, including elderly patients

Generally, an application of approximately 1 cm of ointment will be made in the affected eye(s) every 3 hours, or more frequently during the first 48 hours, and the interval between applications may 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 duration of treatment is 10-14 days.

Usage recommendations:

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

If you use more OFTALMOLOSA CUSÍ CLORAMFENICOL than you should,, you can remove it by rinsing your eyes with warm water. Do not apply more ointment until the next dose.

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

If you forgot to use OFTALMOLOSA CUSÍ CLORAMFENICOL,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 OFTALMOLOSA CUSÍ CLORAMFENICOL

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

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

Chloramphenicol may produce a decrease in cells in the bone marrow. Although most cases of blood disorders associated with chloramphenicol occurred after oral administration, defective development has also been produced with ocular use (see section 2. Warnings and Precautions).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this leaflet. You can also report them directly through the national notification systemhttps://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about 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 store at a temperature above 25°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.

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

Composition of OFTALMOLOSA CUSÍ CLORAMFENICOL

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

Appearance of the product and content of the packaging

OFTALMOLOSA CUSÍ CLORAMFENICOL is a white ointment that is presented in an aluminum tube containing 3 g with a polyethylene cap.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

OmniVision GmbH

Lindberghstrasse 9

82178 Puchheim

Germany

Responsible for manufacturing

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

Last review date of this leaflet: November 2016

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