Terramycin 30 mg/g + 10,000 IU/g ointment

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Terramicina 30 mg/g + 10,000 IU/g topical ointment

Oxytetracycline, Polymyxin B

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

  1. 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, because it could harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Terramicina topical ointment is and what it is used for

2. What you need to know before using Terramicina topical ointment

3. How to use Terramicina topical ointment

4. Possible side effects

5. How to store Terramicina topical ointment

6. Contents of the pack and other information

1. What Terramicina topical ointment is and what it is used for

Terramicina topical ointment is a combination of antibiotic substances. It is indicated in adults and children over 12 years of age for the topical treatment of superficial skin infections caused by susceptible microorganisms.

Antibiotics are used to treat bacterial infections and are not effective against viral infections. It is important to 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 after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

You should consult a doctor if your condition worsens or does not improve after 10 days.

2. What you need to know before using Terramicina topical ointment

Do not use Terramicina topical ointment

• if you are allergic to oxytetracycline, polymyxin B, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Terramicina topical ointment, or during treatment with Terramicina topical ointment:

• if local irritation occurs, as treatment should be discontinued
• if you will be exposed to sunlight or ultraviolet light, as sunburn may occur
• if new infections appear, as appropriate measures may be needed
• if you have damaged skin, an open wound, or if treating a large area

Discontinue use of Terramicina topical ointment if a favorable response does not occur quickly, and control the infection first. If irritation develops, stop applications and initiate appropriate symptomatic therapy.

Children and adolescents

Children under 8 years of age

Terramicina topical ointment should not be used in children under 8 years of age due to the risk of tooth discoloration and delayed skeletal development.

Children from 8 to under 12 years of age

Use in children between 8 and 12 years of age should be carefully justified.

Other medicines and Terramicina topical ointment

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, breastfeeding, and fertility

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

There are no data or data are limited regarding the use of this medicine in pregnant women.

If you are breastfeeding, your doctor must decide whether breastfeeding or treatment with this medicine should be discontinued, taking into account the benefit of breastfeeding for the infant and the benefit of treatment for the mother, as a risk to breastfed infants cannot be excluded.

There are no data available on the effect of this medicine on male or female fertility.

Driving and using machines

The influence of Terramicina on the ability to drive and use machines is none or negligible.

3. How to use Terramicina topical ointment

For topical use only.

After thoroughly cleaning the affected skin area, apply a thin layer to the affected area and gently massage. Avoid touching any surface with the tube opening to prevent possible contamination.

Apply the ointment 2 to 3 times a day. Do not stop treatment too early after initial improvement.

Unless you are treating your hands, always wash your hands after using this medicine.

The recommended duration of treatment is 1 week, although this may vary from a few days to several weeks depending on the nature and severity of the infection. Your doctor will determine the appropriate duration of treatment with Terramicina topical ointment. Do not discontinue treatment prematurely, as the infection may recur.

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

If you use more Terramicina topical ointment than you should

Using larger amounts than recommended increases the risk of adverse effects.

If you have used more Terramicina topical ointment than you should, consult your doctor or pharmacist immediately.

In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at: (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Terramicina topical ointment

Do not apply a double dose to make up for missed doses.

Apply the missed dose as soon as you remember, and observe the recommended time interval between doses before the next application.

If you stop using Terramicina topical ointment

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, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported, with frequency not known (cannot be estimated from the available data):

• Contact dermatitis
• Hypersensitivity
• Skin hyperpigmentation
• Photosensitivity reactions may occur after exposure to sunlight or UV radiation
• Oxytetracycline is structurally similar to antibiotics of the tetracycline class and may have similar adverse effects, such as fixed drug eruption.

Other adverse effects in children and adolescents

Tooth discoloration with frequency not known.

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 System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Terramycin topical ointment

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

Store between 15 and 30°C.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the container and additional information

Composition of Terramicina topical ointment

• The active substances are oxytetracycline hydrochloride 30.0 mg and polymyxin B sulfate 10,000 IU.
• The other components (excipients) are liquid paraffin and soft white paraffin.

Appearance of the product and contents of the container

Topical ointment of soft yellow color and smooth texture. It is supplied in tubes containing 4.7 g and 14.2 g of ointment.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Farmasierra Laboratorios SL
Ctra de Irún km 26,200 San Sebastián de los Reyes
28706 Madrid. Spain

Manufacturer

Farmasierra Manufacturing SL
Ctra de Irún km 26,200 San Sebastián de los Reyes
28706 Madrid. Spain

Date of the most recent review of this package leaflet: October 2025

Detailed 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/)