Brentán 20 mg/g + 10 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Brentán 20 mg/g + 10 mg/g cream

(miconazole nitrate + hydrocortisone)

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• 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.

Leaflet contents:

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

1. What Brentán is and what it is used for

Brentán contains an antifungal drug (miconazole nitrate) and a corticosteroid (hydrocortisone). It belongs to a group of medicines used to treat fungal skin infections in which inflammation and itching are also present.

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

Brentán is particularly indicated in the initial phases of treatment.

2. What you need to know before using Brentán

Do not use Brentán

• If you are allergic to miconazole, to other similar antifungal agents, to hydrocortisone, or to 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 of the skin, as Brentán contains a corticosteroid (hydrocortisone), which may produce an immunosuppressive effect.

Warnings and precautions

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

Brentán may cause serious 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 develops in the treated area, treatment must be discontinued.

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

This medicine should be applied with caution on damaged skin areas such as wounds or fissures, as it may increase the likelihood of adverse reactions. It should also be used cautiously on areas with very fragile skin, such as the face, or areas where bruising occurs easily, as this medicine may increase skin thinning.

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

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 the urine, black tarry stools, or vomiting material resembling ground coffee during treatment with Brentán. Close monitoring of International Normalized Ratio (INR) levels is required during treatment with Brentán, under the supervision of a healthcare professional.

Take the following precautions:

Keep a separate towel and washcloth for your own use. This will help prevent spreading infection to others.

Change regularly the clothing that comes into contact with infected skin to avoid re-infecting yourself.

Brentán cream may damage certain synthetic fabrics; therefore, it is recommended to wear cotton underwear if applying the cream to areas that will be in contact with clothing.

Children

Should be used under medical supervision. Children are particularly sensitive to the adverse effects of corticosteroids, and there is a greater likelihood that the corticosteroid may be absorbed through the skin and cause adverse effects in other parts of the body. This is especially important during long-term treatment.

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

Interference with diagnostic tests

Brentán may interfere with diagnostic test results for adrenal function, which may be reduced, as well as with blood and urine glucose (sugar) concentrations, which may appear increased if the medication has been absorbed.

Other medicines and Brentán

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

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

Some medicines may affect how Brentán works or make it more likely that you experience adverse effects. Brentán may also affect how 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 reduce blood clotting).
• Oral hypoglycemics (medicines used to lower 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The active ingredients in 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 using Brentán.

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

Driving and use of machines

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

Brentán contains benzoic acid, butylated hydroxyanisole, and fragrance 4074

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 butylated hydroxyanisole (E-320).

This medicine contains fragrance 4074 with the following allergens: 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amyl cinnamaldehyde, amyl cinnamyl alcohol, anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, benzyl cinnamate, cinnamaldehyde, cinnamyl alcohol, citral, citronellol, coumarin, d-Limonene, eugenol, farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, isoeugenol, linalool, and methyl heptine carbonate. These allergens may cause allergic reactions. In addition to allergic reactions in sensitized patients, sensitization may occur in non-sensitized patients.

3. How to use Brentán

Follow exactly the instructions for administration of this medicine provided by your doctor or pharmacist. If in doubt, 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 daily. The duration of treatment ranges from 2 to 6 weeks, depending on the extent and type of lesion.

Once itching and inflammation have disappeared, you may continue treatment with a miconazole cream without corticosteroid instead of Brentán.

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

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

Then wash your hands carefully, unless the treatment is for the hands. This is especially important to prevent spreading the infection to other people or to other areas of your own 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 more Brentán than 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, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to use Brentán

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

If you interrupt treatment with Brentán

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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Inform your doctor or pharmacist if you experience any of the following adverse effects:

Frequent (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, stinging, or warmth sensation on the skin
• Urticaria
• Itching
• Skin inflammation
• Skin discoloration

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

• Skin weakening
• Skin fragility
• Inflammation of skin follicles
• Acne
• Spider veins
• Reddish stretch marks on the skin
• Excessive hair growth (hypertrichosis)
• Darkening of the skin

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

• Hypersensitivity (allergy) to any of the components of Brentán
• Skin 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
• Redness of the skin
• Contact dermatitis
• Tachyphylaxis (reduced effect of this medicine due to repeated use)
• Rebound phenomenon (worsening of symptoms upon stopping treatment)

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

• Blurred vision (see section Warnings and precautions)

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

An allergic reaction which may include:

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

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: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Brentán

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

Always keep the tube tightly closed.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton 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 packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Brentán

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

• The other components are ethylene glycol palmitostearate and polyethylene glycol, macrogolglycerides of oleyl alcohol, light liquid paraffin, perfume 4074 (contains 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amyl cinnamaldehyde, amyl cinnamyl alcohol, anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamyl benzoate, cinnamaldehyde, cinnamyl alcohol, citral, citronellol, coumarin, d-Limonene, eugenol, farnesol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, isoeugenol, linalool and methyl heptine carbonate), benzoic acid (E-210), disodium edetate, butylhydroxyanisole (E-320) and purified water.

Appearance of the product and contents of the pack

Brentán is a homogeneous white cream with a perfumed odour, supplied in an aluminium tube with a white screw cap containing 30 grams.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of this leaflet: August 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/)