Dermosa Aureomycin 30 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dermosa Aureomicina 30 mg/g ointment

hydrochloride clortetracycline

Read the entire 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 or pharmacist.
• 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, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Dermosa Aureomicina is and what it is used for

2. What you need to know before using Dermosa Aureomicina

3. How to use Dermosa Aureomicina

4. Possible side effects

5. How to store Dermosa Aureomicina

6. Contents of the container and other information

1. What Dermosa Aureomicina is and what it is used for

Dermosa Aureomicina ointment contains an antibiotic from the tetracycline family.

It is used in the treatment of certain cutaneous infections caused by susceptible microorganisms.

You should consult your doctor if your condition worsens or does not improve after 8 days.

2. What you need to know before starting to use Dermosa Aureomicina

Do not use Dermosa Aureomicina

• if you are allergic to the active substance, to tetracyclines in general, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dermosa Aureomicina.

• Exposure to sunlight and UV radiation should be avoided due to the risk of skin reactions.
• It must not be used on suppurating or macerated lesions, nor in skin folds or leg ulcers.
• It must not be applied to the eyes, ears, inside the mouth, or on other mucous membranes. In case of accidental contact with eyes or ears, immediate washing with abundant water is recommended.

Children and adolescents

This medicine is contraindicated in this population.

Other medicines and Dermosa Aureomicina

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

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.

Pregnancy

The use of Dermosa Aureomicina is not recommended during pregnancy.

Breastfeeding

Dermosa Aureomicina must not be used during breastfeeding unless your doctor considers it absolutely necessary.

Driving and using machines

Dermosa Aureomicina does not affect the ability to drive or operate machinery.

3. How to use Dermosa Aureomicina

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

The recommended dose is 1 or 2 applications of ointment per day.

The duration of treatment will not exceed 8 days to avoid the development of resistance.

Use in children and adolescents

Dermosa Aureomicina is not indicated for use in children and adolescents.

Method of administration

For topical use.

Apply a small amount of ointment directly to the affected area, gently massaging it in. Clean the area before applying the ointment. Avoid touching any surface with the tube opening to prevent possible contamination of the tube contents.

Wash your hands after applying the ointment.

If you use more Dermosa Aureomicina than you should

If you have used more Dermosa Aureomicina than you should, consult your doctor or pharmacist immediately.

Due to the characteristics of the preparation, intoxication phenomena are not expected with topical use of the medicine.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the quantity used.

If you forget to use Dermosa Aureomicina

Remember to always use your medicine as directed.

Do not apply a double dose to make up for missed doses. If you forget to apply a dose, apply it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule.

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

If you interrupt treatment with Dermosa Aureomicina

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Dermosa Aureomicina may cause some adverse effects such as:

Frequency not known (cannot be estimated from available data)

• Hypersensitivity reactions, growth of non-sensitive microorganisms, and photosensitivity reactions after exposure to sunlight or UV radiation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dermosa Aureomycin

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 is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point located at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Dermosa Aureomicina 30 mg/g ointment

• The active substance is chlortetracycline hydrochloride (aureomycin). Each gram of ointment contains 30 mg of chlortetracycline hydrochloride.
• The other components are: cholesterol and vaseline.

Appearance of the product and contents of the pack

Dermosa Aureomicina is a homogeneous yellow ointment supplied in tubes containing 15 grams of ointment.

Marketing Authorization Holder and Manufacturer

Teofarma S.r.l.

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia - Italy

Date of the most recent revision of this leaflet: September 2024

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