Label: information for the user

Dermofix 20 mg/g cream

Sertaconazole nitrate

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Sertaconazole belongs to a group of medicines called antifungals (medicines used to treat infections caused by fungi and yeasts).

This medicine is indicated for the treatment of the following superficial skin infections:

• Cutaneous candidiasis, infections that normally affect moist and warm areas of the skin and mucous membranes.
• Pityriasis versicolor, a diseasecharacterized by the appearance of patches on the skin.
• Tinea, a disease that can affect the trunk (body ringworm), groin (inguinal ringworm), feet (foot ringworm), hands (hand ringworm), and scalp (barber's itch).

No use Dermofix

If you are allergic to sertaconazole, imidazoles in general, or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Dermofix 20 mg/g cream.

For external use only. Do not ingest.

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

Do not use occlusive dressings after applying the medication, as it may promote skin absorption.

Discontinue use of this medication if persistent irritation occurs in the treated area.

Children and Adolescents

Not recommended for use in children under 12 years of age, as there are no studies available for this age group.

Other Medications and Dermofix 20 mg/g Cream

If you are being treated or have recently been treated with a topical corticosteroid, consult your doctor, as you should discontinue corticosteroid treatment 2 weeks before starting use of Dermofix cream.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Since sertaconazole is not absorbed through the skin after topical application, pregnancy and breastfeeding do not constitute a contraindication for the use of sertaconazole cream. However, its safety has not been demonstrated in pregnant women or breastfeeding women, so your doctor will evaluate the use or non-use of this medication in this case.

Breastfeeding is not contraindicated, but avoid applying the medication to the nipple area.

Driving and Operating Machines

Since sertaconazole is not absorbed through the skin after topical application, no effects on the ability to drive and operate machines are expected.

Dermofix 20 mg/g Cream Contains Sorbic Acid and Parahydroxybenzoate

This medication may cause local skin reactions (such as contact dermatitis) because it contains sorbic acid (E-200).

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Cutaneous use.

Apply one or two times a day (preferably at night or morning and night), to the affected area in a smooth and uniform manner, making sure to cover an area of approximately 1 centimeter of healthy skin around the affected area.

Clean and dry the affected areas before applying the medication. Wash your hands after each application unless they are the treatment area.

The usual duration of treatment is 3 to 4 weeks.

If symptoms do not improve after 10-14 days of treatment, you must see your doctor.

It is essential to apply general hygiene and cleaning measures to prevent re-infection.

Follow exactly the administration instructions for the medication contained in this leaflet or those indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Use in children and adolescents

Do not recommend use in children under 12 years old.

In children from 12 years old, the dosage regimen for the cream formulation is the same as recommended for adults.

If you use more Dermofix 20 mg/g cream than you should

It is unlikely that you will experience intoxication since sertaconazole does not absorb through the skin.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Do not induce vomiting or perform gastric lavage to avoid aspiration.

If you forgot to use Dermofix 20 mg/g cream

Do not apply a double dose to compensate for the missed doses, continue with the usual regimen and if you have forgotten many doses, consult your doctor or pharmacist immediately.

Like all medications, Dermofix 20 mg/g cream may produce adverse effects, although not everyone will experience them.

The active ingredient sertaconazole does not get absorbed through the skin after application, so any possible adverse effects will only occur in the area of application.

Adverse effectscommon(may affect up to 1 in100 patients)

• Cutaneous alterations such as erythema, burning sensation, itching, widespread vesicles
• Vesicles at the site of application

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the tube and on the boxafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and unused medicines at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Dermofix 20 mg/g cream

• The active ingredient is sertaconazole nitrate

Each gram of cream contains 20 mg of sertaconazole nitrate.

• The other components are:methylparaben (E-218), sorbic acid (E-200), ethylene glycol palmitostearate and polyethylene glycols, mono-di-triglycerides of stearic acid, triglycerides of saturated fatty acids, liquid petrolatum, and water.

Appearance of the product and contents of the packaging

Aluminum tube with screw cap containing a white or almost white fluid cream.

Each tube contains 30 grams or 60 grams of cream.

Marketing Authorization Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès (Barcelona)

Spain

Last review date of this leaflet:July 2022

Other sources of information

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