Terracortril 5 mg/g + 10 mg/g + 10,000 IU/g ophthalmic and otic ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Terracortril 5 mg/g + 10 mg/g + 10,000 IU/g otic-ophthalmic ointment

Oxytetracycline, Hydrocortisone, Polymyxin B

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 others, 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 are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Terracortril otic-ophthalmic ointment is and what it is used for

2. What you need to know before using Terracortril otic-ophthalmic ointment

3. How to use Terracortril otic-ophthalmic ointment

4. Possible side effects

5. Storage of Terracortril otic-ophthalmic ointment

6. Contents of the pack and other information

1. What Terracortril Ophthalmic and Otic Ointment Is and What It Is Used For

Terracortril Ophthalmic and Otic Ointment is a combination of anti-inflammatory and anti-infective agents. It is indicated in adults and children over 12 years of age for the treatment of infections caused by organisms susceptible to the antibiotic component, and for the treatment of conditions where the use of hydrocortisone is indicated, when located in the eye or ear.

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 dosage, dosing intervals, and duration of treatment. Do not store or reuse this medicine. If you have leftover antibiotic 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 ophthalmic and otic ointment

Do not use Terracortril ophthalmic and otic ointment

• if you are allergic to oxytetracycline, hydrocortisone acetate, polymyxin B, or any of the other ingredients of this medicine (listed in section 6).
• if you have glaucoma (high intraocular pressure)
• if you have acute herpes simplex, chickenpox, or any other viral infection affecting the eye or ear,
• infections caused by mycobacteria
• if you have fungal infections of the eye or ear,
• if a foreign body has recently been removed, uncomplicated, from the cornea (ophthalmic use)
• in case of perforation of the eardrum (otic use)

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Terracortril ophthalmic and otic ointment, or during treatment with Terracortril ophthalmic and otic 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 perforation of the eardrum

• if you are going to use ophthalmic corticosteroids long-term, as this may cause:

• eye disorders such as glaucoma, optic nerve damage, visual acuity disturbances, posterior cataract formation, corneal thinning: if treatment lasts 10 days or more, your intraocular pressure should be monitored

• increased risk of secondary ocular infections,

• masking of an infection, or reactivation of an existing infection.

The use of contact lenses during ophthalmic treatment with corticosteroid-containing medicines is not recommended.

Discontinue corticosteroid use if a favorable response does not occur rapidly, and treat the infection first.

A rebound effect may occur after discontinuation of treatment.

Children and adolescents

Children under 8 years of age

Terracortril ophthalmic and otic ointment must 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

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

Other medicines and Terracortril ophthalmic and otic ointment

Tell 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 might be pregnant, or plan 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 must decide whether to discontinue breastfeeding or stop treatment with this medicine, 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 use of machines

You may notice that your vision becomes blurred for a short time after applying the ointment. Do not drive or operate machinery until these effects have subsided.

3. How to use Terracortril otic-ophthalmic ointment

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Ophthalmic use

Apply directly from the tube a small 1 cm strip of ointment inside the lower eyelid of the affected eye. Administer 3 times a day. Avoid letting the tip of the tube touch the eye or any other surface to prevent possible contamination of the tube contents.

If more than one medicine is used by ophthalmic route, the applications should be spaced at least 5 minutes apart. Ophthalmic ointments should be administered last.

Otic use

Apply a 1 cm strip of ointment into the ear canal. Administer 3 times a day. Apply without touching the tip of the tube to the treatment area to avoid contamination.

The ear canal should remain free of exudate, cerumen, or debris during treatment.

The duration of treatment will depend on the nature and severity of the infection and may vary from a few days to several weeks. Your doctor will determine how long you should use Terracortril otic-ophthalmic ointment. Do not stop treatment prematurely, as the infection may recur.

Use in children and adolescents

Children under 8 years of age

Terracortril otic-ophthalmic ointment must not be used in children under 8 years of age due to the risk of tooth discoloration and delayed skeletal development.

Children from 8 years to under 12 years of age

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

If you use more Terracortril otic-ophthalmic ointment than you should

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

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

If you forget to use Terracortril otic-ophthalmic ointment

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

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

If you stop treatment with Terramicina ophthalmic ointment

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

How to open the tube

The tube is sealed. When using the tube for the first time, unscrew the base of the cap to remove the inner ring. Then screw the cap back on.

The top part of the cap can be unscrewed and the tube is ready for use.

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):

• Bacterial or fungal infection
• Allergic reactions
• Burning sensation
• Glaucoma – increased intraocular pressure
• Eye pain
• Eye irritation
• Blurred vision
• Foreign body sensation in the eye
• Delayed healing
• Impaired healing
• Optic nerve damage
• Subcapsular cataract
• Contact dermatitis
• Periorbital dermatitis
• 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, 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 through 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 Otic Ophthalmic Ointment

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

Store between 15 and 30ºC.

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.

Discard 4 weeks after first opening.

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

6. Contents of the package and other information

Composition of Terracortril ophthalmic-otic ointment

• The active substances are oxytetracycline hydrochloride 5.0 mg, hydrocortisone acetate 10.0 mg and polymyxin B sulfate 10,000 U.
• The other components (excipients) are liquid paraffin and soft white paraffin.

Appearance of the medicine and contents of the pack

Ophthalmic-otic ointment of soft yellow color and smooth texture. It is supplied in tubes containing 3.5 g of ointment.

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