DERMOSA AUREOMICINA 30 mg/g OINTMENT

Introduction

Package Leaflet: Information for the Patient

Dermosa Aureomicina 30 mg/g Ointment

Chlortetracycline hydrochloride

Read the entire package leaflet carefully before starting to use this medication, 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 or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Dermosa Aureomicina and what is it used for
2. What you need to know before using Dermosa Aureomicina
3. How to use Dermosa Aureomicina
4. Possible side effects
5. Storage of Dermosa Aureomicina

1. Contents of the packaging and additional information

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

Dermosa Aureomicina ointment contains an antibiotic from the tetracycline family.

It is used in the treatment of certain skin infections caused by sensitive microorganisms.

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

2. What you need to know before using 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 medication (listed in section 6).

Warnings and precautions

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

• Sun exposure and UV radiation should be avoided due to the risk of skin reactions.
• It should not be used on suppurating or macerated lesions, or on folds or leg ulcers.
• It should not be applied to the eyes, ears, or inside the mouth and other mucous membranes. In case of accidental contact with eyes and ears, it is recommended to rinse immediately with plenty of water.

Children and adolescents

It is contraindicated in this population.

Other medications and Dermosa Aureomicina

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The administration of Dermosa Aureomicina is not recommended during pregnancy.

Breastfeeding

Dermosa Aureomicina should 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 use machinery.

3. How to use Dermosa Aureomicina

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 1 or 2 applications of ointment per day.

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

Use in children and adolescents

Dermosa aureomicina is not indicated in children and adolescents.

Method of administration

Topical use.

A small amount of ointment should be applied directly to the affected area, giving a gentle massage. Clean the area before applying the ointment. Avoid touching any surface with the tube mouth 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 Dermosa Aureomicina more than you should, consult your doctor or pharmacist immediately.

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

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

If you forget to use Dermosa Aureomicina

Remember to always use your medication.

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

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

If you interrupt treatment with Dermosa Aureomicina

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Dermosa Aureomicina may cause some side 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dermosa Aureomicina

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

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

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Dermosa Aureomicina 30 mg/g ointment

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

Appearance of the product and contents of the packaging

Dermosa Aureomicina is a homogeneous ointment of yellow color and is presented 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 last revision of this package leaflet: September 2024

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