BRENTÁN 20 MG/G + 10 MG/G CREAM

Introduction

Package Leaflet: Information for the Patient

Brentán 20 mg/g + 10 mg/g Cream

(miconazole nitrate + hydrocortisone)

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Brentán and what is it used for
2. What you need to know before you start using Brentán
3. How to use Brentán
4. Possible side effects
5. Storage of Brentán
6. Contents of the pack and further information

1. What is Brentán and what is it used for

Brentán contains an antifungal medicine (miconazole nitrate) and a corticosteroid (hydrocortisone). It belongs to a group of medicines used to treat skin infections caused by fungi, where there is also inflammation and itching.

Brentán is especially recommended for cases of redness and pronounced itching.

Brentán is especially indicated in the initial stages of treatment.

2. What you need to know before you start using Brentán

Do not useBrentán

• If you are allergic to miconazole, other similar antifungals, hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
• If you have a skin infection caused by bacteria, viruses (herpes, chickenpox or vaccine virus), parasites or tuberculosis on the skin, since Brentán contains a corticosteroid (hydrocortisone), which can have an immunosuppressive effect.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

Brentán can cause severe allergic reactions. You should be aware of the signs of an allergic reaction when using this medicine (see section 4 "Possible side effects").

If irritation or allergy occurs in the treated area, you should discontinue treatment.

Avoid contact with the eyes and mucous membranes. In case of accidental contact, rinse your eyes with plenty of water.

This medicine should be applied with caution to areas where the skin is damaged with wounds or fissures, as it may increase the likelihood of adverse reactions. It should also be applied with caution to areas with very fragile skin, such as the face, or if you bruise easily, as this medicine may increase skin thinning.

Due to the corticosteroid component (hydrocortisone), the use of Brentán is not recommended for prolonged treatments. Once the inflammatory symptoms (redness and itching) have disappeared, treatment should be continued with a cream that contains only miconazole (antifungal). Follow your doctor's instructions regarding the duration of treatment.

Contact your doctor if you experience blurred vision or other visual disturbances.

If you are taking oral anticoagulants such as warfarin, stop using Brentán immediately and consult your doctor or pharmacist if you experience unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in your urine, black tarry stools or vomiting with a color and texture similar to ground coffee during treatment with Brentán. During treatment with Brentán, close monitoring of International Normalized Ratio (INR) levels is required under the supervision of a healthcare professional.

Take the following precautions:

Keep a towel and a washcloth for your own use. This will help prevent you from infecting others.

Regularly change the clothes that come into contact with the infected skin to avoid reinfecting yourself.

Brentán cream can damage some synthetic fibers, so it is recommended to wear cotton underwear in case you need to apply the cream to an area that comes into contact with these garments.

Children

It should be used under medical supervision. Children are especially sensitive to the adverse effects of corticosteroids and it is more likely that the corticosteroid will pass into the body through the skin and have adverse effects in other areas of the body. This is especially important in long-term treatments.

Caution should be exercised when applying this medicine to a large surface area or under occlusive dressing (e.g., under a diaper), as large amounts of the medicine may be absorbed through the skin.

Interference with laboratory tests

Brentán may interfere with the results of diagnostic tests for adrenal function, which may be decreased, as well as blood and urine glucose concentrations, which may be increased if the medicine has been absorbed.

Other medicines and Brentán

Consult your doctor, pharmacist or dentist if you are taking, have recently taken or might take other medicines.

Oral anticoagulants (medicines used to thin the blood), such as warfarin, may be affected by Brentán.

Some medicines may affect the way Brentán works or make it more likely that you will have side effects. Brentán may also affect the way other medicines work.

If you are taking any of these medicines or others, consult your doctor or pharmacist before starting to use Brentán:

• Oral anticoagulants such as warfarin (medicines used to decrease blood clotting).
• Oral hypoglycemics (medicines used to decrease blood sugar levels).
• Phenytoin (a medicine used to treat epilepsy).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

The active ingredients of Brentán, miconazole and hydrocortisone, are absorbed in small amounts when applied to the skin. Brentán should not be used during pregnancy or breastfeeding, unless your doctor has evaluated the benefits and risks of treatment.

If you are pregnant or breastfeeding, ask your doctor about the use of Brentán.

If Brentán is used during breastfeeding, it should not be applied to the breasts immediately before breastfeeding.

Driving and using machines

Brentán is not expected to affect your ability to drive or use machines.

Brentán contains benzoic acid and butylhydroxyanisole

This medicine contains 2 mg of benzoic acid per gram of cream. Benzoic acid (E-210) may cause local irritation.

Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole (E-320).

3. How to use Brentán

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

This medicine is for topical use. The amount to be used and the duration of treatment will depend on the type and location of the infection.

The recommended dose is one application twice a day. The duration of treatment varies from 2 to 6 weeks depending on the extent and type of lesion.

Once the itching and inflammation have disappeared, you can continue treatment with a cream that contains only miconazole (antifungal) instead of Brentán.

Do not stop treatment with Brentán or with the miconazole cream until the symptoms have completely disappeared (usually after 2 to 6 weeks).

You should wash and dry the infected skin perfectly and then apply the cream, not only to the affected area but also to the surrounding area, rubbing gently until it is completely absorbed into the skin.

Then wash your hands carefully, unless the treatment is for the hands. This is especially important to avoid infecting others or spreading the infection to other parts of your skin.

To open the tube, unscrew the cap and pierce the seal of the tube by inserting the back of the cap into the mouth of the tube.

If you use moreBrentánthan you should

Prolonged or excessive use may cause irritation, skin atrophy and bruising. In this case, stop using this medicine and inform your doctor.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to useBrentán

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

If you stop treatment withBrentán

Do not stop treatment before the lesions have completely disappeared, as they may worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or pharmacist if you have any of the following side effects:

Common (may affect up to 1 in 10 people)

• Irritability in infants and young children

Uncommon (may affect up to 1 in 100 people)

• Skin irritation
• Burning sensation, burning or heat in the skin
• Hives
• Itching
• Skin inflammation
• Skin discoloration

Rare (may affect up to 1 in 1,000 people)

• Skin weakening
• Skin fragility
• Skin follicle inflammation
• Acne
• Spider veins
• Red streaks on the skin
• Hair growth (hypertrichosis)
• Skin darkening

Very rare (may affect up to 1 in 10,000 people)

• Hypersensitivity (allergy) to any of the components of Brentán
• Rash or allergy
• Hormonal disorders: Cushing's syndrome and hypothalamic-pituitary disorders
• High blood sugar levels
• Presence of sugar in urine
• Swelling of the face, lips, tongue and/or throat that may cause difficulty breathing or swallowing (angioedema)
• Skin rash
• Skin redness
• Contact dermatitis
• Tachyphylaxis (decrease in the effect of this medicine due to repeated use)
• Rebound phenomenon (worsening of symptoms when treatment is stopped)

Not known (frequency cannot be estimated from the available data):

• Blurred vision (see section Warnings and precautions)

If you get any of the following side effects, stop using Brentán and contact your doctor immediately:

An allergic reaction that may include:

• swelling of the face, lips, mouth, tongue or throat,
• difficulty swallowing or breathing,
• skin rash with itching

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Brentán

Keep in the refrigerator (between 2 °C and 8 °C).

Always keep the tube tightly closed.

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition ofBrentán

• The active ingredients are miconazole nitrate and hydrocortisone. Each gram of cream contains 20 mg of miconazole nitrate and 10 mg of hydrocortisone.

• The other ingredients are ethylene glycol palmitostearate and polyethylene glycol, oleoyl macrogolglycerides, light liquid paraffin, perfume 4074, benzoic acid (E-210), disodium edetate, butylhydroxyanisole (E-320) and purified water.

Appearance of the product and pack contents

Brentán is a homogeneous white cream with a perfumed odor, presented in an aluminum tube with a white screw cap containing 30 grams.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer:

KERN PHARMA, S.L.

Venus, 72. Poligono Industrial Colon II

08228 Terrasa, Barcelona

Spain

Date of last revision of this leaflet:August 2025

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