Terracortril 30 mg/g + 10 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Terracortril 30 mg/g + 10 mg/g topical ointment

Oxytetracycline, Hydrocortisone

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.

  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 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.

Contents of the leaflet

1. What Terracortril topical ointment is and what it is used for
2. What you need to know before using Terracortril topical ointment
3. How to use Terracortril topical ointment
4. Possible side effects
5. How to store Terracortril topical ointment
6. Contents of the pack and other information

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

Terracortril topical ointment is a combination of anti-inflammatory and anti-infective substances. It is indicated in adults and children over 12 years of age for the treatment of inflammatory skin conditions that respond to topical corticosteroid therapy and are complicated by secondary 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. Do not dispose of medicines 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 Terracortril topical ointment

Do not use Terracortril topical ointment

• if you are allergic to oxytetracycline, hydrocortisone acetate, or any of the other ingredients of this medicine (listed in section 6).
• if you have tuberculosis or syphilis, viral infections such as herpes or varicella (chickenpox)
• if you have rosacea, perioral dermatitis, ulcers, common acne, atrophic skin diseases, or cutaneous vaccine reactions in the area to be treated
• if you have bacterial or fungal skin infections
• if you have an open wound
• do not apply in the eyes

Warnings and precautions

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

• if local irritation occurs, as treatment should be discontinued
• if you will be exposed to sunlight or ultraviolet light, as it may cause sunburn
• if new infections appear, as appropriate measures may be needed
• if you experience visual disturbances or blurred vision, as you should be examined by an ophthalmologist
• if you have damaged skin, a wound, or if treatment involves a large area
• if you have an acute purulent condition, as the ointment may mask or worsen an existing infection

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

Children and adolescents

Children under 8 years of age

Terracortril 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 Terracortril 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 the data are limited regarding the use of this medicine in pregnant women.

If you are breastfeeding, your doctor will decide whether breastfeeding should be discontinued or treatment with this medicine stopped, after considering the benefit of breastfeeding for the child 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 Terracortril on the ability to drive and use machinery is negligible or none.

3. How to use Terracortril topical ointment

For cutaneous use.

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 2 to 4 times daily. The interval between applications should be gradually increased as an adequate response to treatment is achieved.

The duration of treatment will depend on the nature and severity of the infection, but should not exceed 1 week. Do not stop treatment too early once an initial response has been achieved. Your doctor will determine the appropriate treatment duration; do not discontinue treatment prematurely, as the infection may recur.

Unless you are using the cream to treat your hands, always wash your hands after using this medicine.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

If you use more Terracortril topical ointment than you should

Using more than the recommended amount increases the risk of adverse effects.

If you have used more Terracortril 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 telephone: (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Terracortril topical ointment

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

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

If you stop using Terracortril 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 can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported with an unknown frequency (cannot be estimated from the available data):

• Bacterial or fungal infection
• Burning sensation
• Itching
• Irritation
• Dryness
• Hypertrichosis
• Acneiform eruptions
• Hypopigmentation of the skin
• Contact dermatitis
• Skin maceration
• Skin atrophy
• Striae
• Miliaria

Photosensitivity reactions may occur following exposure to sunlight or UV radiation.

Other adverse effects in children and adolescents

Discoloration of the teeth, 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 Pharmacovigilance System for 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 Terracortril 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 containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Terracortril topical ointment

• The active substances are oxytetracycline hydrochloride 30.0 mg and hydrocortisone 10.0 mg.
• The other components (excipients) are liquid paraffin and soft white paraffin.

Appearance of the product and contents of the pack

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

Only certain pack 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 leaflet:

October 2025

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