Package Insert: Information for the Patient

Dermosa Aureomicina 10 mg/g Ointment

Clortetracycline Hydrochloride

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this package insert. See section 4.

6.Contents of the Package and Additional Information

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.

Do not use Dermosa Aureomicina

• if you are allergic to the active ingredient, 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.

• Avoid exposure to the sun and UV radiation, as there is a risk of skin reactions.
• Do not use on suppurating or macerated wounds, or on leg folds or ulcers.
• Do not apply to the eyes, ears or inside the mouth and other mucous membranes. In the event of accidental contact with eyes and ears, rinse immediately with plenty of water.

Children and adolescents

This is contraindicated in this population.

Other medications and Dermosa Aureomicina

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

Pregnancy and breastfeeding

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.

Pregnancy

The administration of Dermosa Aureomicina is not recommended during pregnancy.

Breastfeeding

During the breastfeeding period, do not use Dermosa Aureomicina unless your doctor considers it absolutely necessary.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as 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 treatment duration will not exceed 8 days to avoid the development of resistances.

Use in children and adolescents

Dermosa Aureomicina is not indicated for children and adolescents.

Administration form

Topical use.

Apply a small amount of ointment directly to the affected area, giving a gentle massage. Clean the area before applying the ointment. Avoid touching any surface with the tube's mouth to prevent possible contamination of the tube's contents.

Wash your hands after applying the ointment.

If you use moreDermosa Aureomicinathan 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, it is not expected to experience intoxication phenomena with the topical use of the medication.

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

If you forgot to use Dermosa Aureomicina

Remember to always use your medication.

Do not apply a double dose to compensate for the 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 the regular dosing schedule.

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

If you interrupt the treatment with Dermosa Aureomicina

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

Aureomicina Dermosa may cause some adverse effects, such as:

Unknown Frequency(cannot be estimated from available data)

• Reactions of hypersensitivity, growth of non-susceptible microorganisms, and photosensitivity reactions after exposure to sunlight or UV radiation.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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.

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the Pharmacy Take-Back Point. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dermosa Aureomicina 10 mg/g ointment

• The active ingredient is clortetracycline hydrochloride (aureomicin). Each gram of ointment contains 10 mg of clortetracycline hydrochloride
• The other components are: cholesterol and petroleum jelly.

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.r.l.

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia - Italy

Date of the last review of this leaflet: September 2024

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