Dermofix 20 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dermofix 20 mg/g cream

Sertaconazole nitrate

Read the entire 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 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Dermofix 20 mg/g cream is and what it is used for
2. What you need to know before using Dermofix 20 mg/g cream
3. How to use Dermofix 20 mg/g cream
4. Possible adverse effects
5. How to store Dermofix 20 mg/g cream
6. Contents of the pack and other information

1. What Dermofix 20 mg/g cream is and what it is used for

Sertaconazole belongs to a group of medicines known as 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 warm, moist areas of the skin and mucous membranes.
• Pityriasis versicolor, a condition characterized by the appearance of discolored patches distributed across the skin.
• Tinea infections, a disease that may affect the trunk (tinea corporis), groin (tinea cruris), feet (tinea pedis), hands (tinea manuum), and scalp (tinea capitis).

2. What you need to know before using Dermofix 20 mg/g cream

Do not use Dermofix

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

Warnings and precautions

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

This medicine is for external use only. Do not ingest.

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

The use of occlusive dressings after application of the medicine is not recommended, as it may enhance skin absorption.

Treatment with this medicine should be discontinued if persistent irritation occurs at the site of application.

Children and adolescents

Use in children under 12 years of age is not recommended due to lack of studies in this age group.

Other medicines and Dermofix 20 mg/g cream

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

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

Pregnancy and breastfeeding

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.

Since sertaconazole is not absorbed through the skin following topical application, pregnancy and breastfeeding do not constitute contraindications for the use of sertaconazole cream. However, its safety in pregnant or breastfeeding women has not been established, and therefore your doctor will assess whether or not this medicine should be used in such cases.

Breastfeeding is not contraindicated, but application of the medicine on the nipple area should be avoided.

Driving and using machines

Since sertaconazole is not absorbed through the skin following topical application, effects on the ability to drive or operate machinery are not expected.

Dermofix 20 mg/g cream contains sorbic acid and parahydroxybenzoates

This medicine 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).

3. How to use Dermofix 20 mg/g cream

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For topical use.

Apply once or twice daily (preferably at night or morning and night) to the affected area gently and evenly, making sure to also cover approximately 1 centimeter of healthy skin surrounding the affected area.

Clean and dry the affected areas before applying the medicine. Wash your hands after each application unless the hands themselves are the area being treated.

The usual duration of treatment is 3 to 4 weeks.

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

It is essential to follow general hygiene and cleaning measures to prevent reinfection.

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

Use in children and adolescents

Use is not recommended in children under 12 years of age.

In children aged 12 years and older, the dosage regimen for the cream formulation is the same as that recommended for adults.

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

Poisoning is unlikely to occur because sertaconazole is not absorbed through the skin.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to use Dermofix 20 mg/g cream

Do not apply a double dose to make up for missed doses. Continue with your usual dosing schedule. If you have missed several doses, consult your doctor or pharmacist immediately.

4. Possible adverse effects

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

The active substance sertaconazole is not absorbed after application to the skin, therefore any possible adverse effects occur only at the site of application.

Uncommon adverse effects (may affect up to 1 in 100 patients)

• Skin disorders such as erythema, burning sensation, itching, disseminated vesicles
• Vesicles at the site of application

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 Dermofix 20 mg/g cream

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Dermofix 20 mg/g cream

• The active substance 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 paraffin, and water.

Appearance of the product and contents of the container

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)

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès (Barcelona)

Spain

Date of the most recent review of this leaflet: July 2022

Other sources of information

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