Package Leaflet: Information for the User

OFTALMOLOSA CUSÍ AUREOMICINA 5mg/g Ophthalmic Ointment

Clortetracycline Hydrochloride

Read this 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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

2.What you need to know before using 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 additional information

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

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

In severe eye infections, eye ointment application should be completed with the systemic administration of an appropriate antibiotic.

Do not use OFTALMOLOSA CUSÍ AUREOMICINA:

• If you are allergic to clortetraciclina, to other tetraciclinas or to any of the other components of this medication (included in section 6).

Warnings and precautions

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

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

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

Interaction of OFTALMOLOSA CUSÍ AUREOMICINA with other medications

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

Pregnancy, breastfeeding and fertility

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

Driving and operating machines

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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.

Usage recommendations:

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

If you use more OFTALMOLOSA CUSÍ AUREOMICINA than you should,, you may remove it by rinsing your eyes with warm water. Do not apply more ointment until it is needed again.

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

If you forgot to use OFTALMOLOSA CUSÍ AUREOMICINA,apply it as soon as you rememberandcontinue with the next dose that was 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 the treatment with OFTALMOLOSA CUSÍ AUREOMICINA

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 have been fully cured and symptoms may return or even worsen. Additionally, antibiotic resistance (loss of effectiveness) could be generated.

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

Like all medications, OFTALMOLOSA CUSÍ AUREOMICINA may cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed with this medication:

Unknown frequency (cannot be estimated from available data):

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

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Record the date of opening the tube in the reserved box on the packaging.

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

Composition of OFTALMOLOSA CUSÍ AUREOMICINA

• The active ingredient is hydrochloride of clortetracycline. Each gram of ointment contains 5mg of hydrochloride of clortetracycline.
• The other components are cholesterol, liquid paraffin and white vaseline.

Appearance of the product and contents of the packaging

OFTALMOLOSA CUSÍ AUREOMICINAis a yellow ointment that is presented in an aluminium tube containing 3 g with a polyethylene plug.

Holder of the marketing authorization

NTC s.r.l.,

via Luigi Razza 3,

20124 Milan, Italy

Responsible for manufacturing

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 holder of the marketing authorization:

NTC Ophthalmics Iberica SL,

Calle Pinar, 5,

28006 Madrid, Spain

This leaflet was approved in December 2011.

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