Aureomycin 5 mg/g ophthalmic ointment Cusi

Spain
Brand name Aureomycin 5 mg/g ophthalmic ointment Cusi
Form ointment, ophthalmic
Active substance / Dosage
Chlortetracycline hydrochloride · 5 mg
Prescription type Prescription Only Medicine
ATC code
S01A S01AA S01AA02
Registration number 13909
Manufacturer Ntc S.R.L.
Aureomycin 5 mg/g ophthalmic ointment Cusi ointment, ophthalmic

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OFTALMOLOSA CUSÍ AUREOMICINA 5mg/g eye ointment

Chlortetracycline hydrochloride

Read all of 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, and you should not give it to other people, even if they have the same symptoms as you. It could harm them.
  • If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet.

Contents of the leaflet

  1. What OFTALMOLOSA CUSÍ AUREOMICINA is 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. How to store OFTALMOLOSA CUSÍ AUREOMICINA
  6. Contents of the pack and other information

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

OFTALMOLOSA CUSÍ AUREOMICINA is an eye ointment containing an antibiotic (clortetraciclina) belonging to the group known as tetracyclines, which acts against many microorganisms causing 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. Medicines must not be disposed of via wastewater or household waste.

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

In severe eye infections, topical ophthalmic application should be supplemented with systemic administration of an appropriate antibiotic.

2. What you need to know before using OFTALMOLOSA CUSÍ AUREOMICINA

Do not use OFTALMOLOSA CUSÍ AUREOMICINA:

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

Warnings and precautions

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

  • Use this medicine only in the eye(s).

  • If you develop symptoms of an allergic reaction, stop treatment and consult your doctor. This medicine may cause allergic reactions.

  • If you develop skin inflammation or redness, stop treatment and consult your doctor. This medicine may also cause sensitivity to light.

  • If your symptoms worsen or return, consult your doctor. With use of this medicine, you may become more susceptible to other infections.

  • If you wear contact lenses:

  • Wearing contact lenses (rigid or soft) is not recommended during 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 might need to use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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 blurred vision. Do not drive or operate machinery until your vision is clear.

3. How to use OFTALMOLOSA CUSÍ AUREOMICINA

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

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 duration of treatment may be adjusted according to medical judgment.

Usage recommendations:

  • Take the tube.
  • Wash your hands and position yourself in front of a mirror.
  • If the application is inside the eye, pull down the eyelid with a clean finger. Apply the ointment into the pouch formed between the eyelid and the eye.
  • If the application is outside the eye, apply the ointment directly to the affected area, first softening and removing any crusts with warm water.
  • Place the tip of the tube close to the eye. Use a mirror if needed.
  • Avoid touching the eyes, eyelids, surrounding areas, or other surfaces with the tip of the tube.
  • Gently press the tube to release the ointment.
  • Close the eye(s) for a few seconds after applying the ointment.
  • Close the tube tightly after use.

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

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

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 medication and the amount used.

If you forget to use OFTALMOLOSA CUSÍ AUREOMICINA, 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 regular dosing schedule. Do not apply a double dose to make up for missed doses.

If you stop treatment with OFTALMOLOSA CUSÍ AUREOMICINA

It is important that you complete the full course of treatment prescribed by your doctor, even if you start feeling better after a few days. If you stop using this medicine too early, the infection may not be completely cured, and symptoms may return or even worsen. Additionally, antibiotic resistance (loss of effectiveness) could develop.

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

4. Possible adverse effects

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

The following adverse effects have been observed with this medicine:

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

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

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

Record the date you opened the tube in the space provided for this purpose on the carton.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of OFTALMOLOSA CUSÍ AUREOMICINA

  • The active substance is chlortetracycline hydrochloride. Each gram of ointment contains 5 mg of chlortetracycline hydrochloride.
  • The other components are cholesterol, liquid paraffin, and white soft paraffin.

Appearance of the product and contents of the pack

OFTALMOLOSA CUSÍ AUREOMICINA is an ointment (yellow) supplied 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 responsible for batch release

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

NTC Ophthalmics Iberica SL,

Calle Pinar, 5,

28006 Madrid, Spain

This Patient Information Leaflet was approved in December 2011.

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