OFTALMOLOSA CUSI AUREOMICINA 5 mg/g OPHTHALMIC OINTMENT

Introduction

Package Leaflet: Information for the User

OFTALMOLOSA CUSÍ AUREOMICINA 5mg/g Ophthalmic Ointment

Hydrochloride of Chlortetracycline

Read the entire package leaflet carefully before starting to use this 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, pharmacist, or nurse.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet.

Contents of the Package Leaflet

1. What OFTALMOLOSA CUSÍ AUREOMICINA is and what it is used for
2. What you need to know before starting to use OFTALMOLOSA CUSÍ AUREOMICINA
3. How to use OFTALMOLOSA CUSÍ AUREOMICINA
4. Possible side effects
5. Storage of OFTALMOLOSA CUSÍ AUREOMICINA
6. Contents of the pack and further information

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

OFTALMOLOSA CUSÍ AUREOMICINA is an eye ointment that contains an antibiotic (chlortetracycline) from the group called tetracyclines, which acts against many microorganisms that cause eye infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

It is used for the treatment of external bacterial eye infections caused by germs sensitive to chlortetracycline, such as hordeolum, conjunctivitis, and blepharitis (inflammation of the eyelids).

In severe eye infections, ophthalmic application should be complemented with the systemic administration of a suitable antibiotic.

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

Do not use OFTALMOLOSA CUSÍ AUREOMICINA:

• If you are allergic to chlortetracycline, other tetracyclines, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use OFTALMOLOSA CUSÍ AUREOMICINA.

• Use this medicine only in the eye(s)
• If you experience symptoms of an allergic reaction, discontinue treatment and consult your doctor. This medicine may cause allergic reactions.
• If you experience skin inflammation or redness, discontinue treatment and consult your doctor. This medicine may also cause sensitivity to light.
• If your symptoms worsen or return, consult your doctor. With the use of this medicine, you may become more sensitive to other infections.
• If you use contact lenses:

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

Interaction of OFTALMOLOSA CUSÍ AUREOMICINA with other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or 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, unless your doctor considers it necessary.

Driving and using machines

Immediately after applying this ointment, you may notice that your vision becomes blurry. Do not drive or use machines until your vision is clear.

3. How to use OFTALMOLOSA CUSÍ AUREOMICINA

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults (including elderly patients) and children

Generally, apply approximately 1 cm of ointment to the affected eye(s) two or three times a day.

The number of daily applications and the duration of treatment may be modified according to medical criteria.

Recommendations for use:

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

If you use more OFTALMOLOSA CUSÍ AUREOMICINA than you should, you can remove it by washing your eyes with lukewarm water. Do not apply more ointment until it is time for your next dose.

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

If you forget to use OFTALMOLOSA CUSÍ AUREOMICINA, 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 dosing schedule. Do notapply a double dose to make up for missed doses.

If you stop using OFTALMOLOSA CUSÍ AUREOMICINA

It is essential to 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, the infection may not be completely cured, and the symptoms may return or worsen. Resistance to the antibiotic (loss of effectiveness) may also occur.

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

4. Possible side effects

Like all medicines, OFTALMOLOSA CUSÍ AUREOMICINA can cause side effects, although not everyone gets them.

The following side effects have been observed with this medicine:

Frequency not known (cannot be estimated from available data):

Eye effects: pain, itching, abnormal sensation, irritation, and redness.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet.

5. Storage of OFTALMOLOSA CUSÍ AUREOMICINA

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

To avoid infections, the tube should be discarded 4 weeks after it was first opened.

Write the opening date of the tube in the space provided for this purpose 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 any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of OFTALMOLOSA CUSÍ AUREOMICINA

• The active ingredient is chlortetracycline hydrochloride. Each gram of ointment contains 5 mg of chlortetracycline hydrochloride.
• The other ingredients are cholesterol, liquid paraffin, and white petrolatum.

Appearance and packaging of the product

OFTALMOLOSA CUSÍ AUREOMICINA is a yellow ointment presented in an aluminum tube containing 3 g with a polyethylene cap.

Marketing authorization 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

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

This package leaflet was approved in December 2011.

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/