Dermofix 20 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dermofix 20 mg/ml cutaneous solution

Sertaconazole nitrate

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.
• 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 other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Dermofix 20 mg/ml cutaneous solution is and what it is used for

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 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/ml cutaneous solution

Do not use Dermofix 20 mg/ml cutaneous solution

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Dermofix 20 mg/ml cutaneous solution.

For external use only. Do not ingest.

Contact with eyes and mucous membranes must be avoided. In case of accidental contact, rinse eyes thoroughly with water.

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

You should discontinue use of this medicine if persistent irritation develops at the treated site.

Children and adolescents

There are no data available on use in children due to lack of studies in this age group.

Other medicines and Dermofix 20 mg/ml cutaneous solution

If you are currently being treated or have recently been treated with a topical corticosteroid, consult your doctor, as treatment with the corticoster should be discontinued 2 weeks prior to starting Dermofix cutaneous powder.

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

Pregnancy and breast-feeding

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 a contraindication for the use of sertaconazole cutaneous powder. However, its safety during pregnancy and breastfeeding has not been established, so 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

As sertaconazole is not absorbed through the skin following topical application, no effects on the ability to drive or operate machinery are expected.

3. How to use Dermofix 20 mg/ml cutaneous solution

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

For cutaneous use only.

Apply once or twice daily (preferably at night or morning and night) to the affected area in a gentle and uniform manner, 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 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 consult your doctor.

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

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

If you use more Dermofix 20 mg/ml cutaneous solution than you should

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

In case of overdose or accidental ingestion, contact 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/ml cutaneous solution

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

Dermofix 20 mg/ml cutaneous solution contains formaldehyde and ethanol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains formaldehyde.

This medicine contains alcohol (ethanol). It may cause a burning sensation on damaged skin.

4. Possible adverse effects

Like all medicines, Dermofix 20 mg/ml cutaneous solution may cause 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.

Frequent adverse effects (may affect up to 1 in 10 patients)

Skin disorders such as erythema, local burning/itching sensation, and dry skin.

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

Skin disorders such as contact dermatitis (redness of the skin following direct contact with a substance).

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 Medicines: 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/ml cutaneous solution

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 outer carton following 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 containers at a SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dermofix 20 mg/ml cutaneous solution

• The active substance is sertaconazole nitrate. Each milliliter of solution contains 20 mg of sertaconazole nitrate.
• The other components are: glycerol formaldehyde, propylene glycol (E-1520) and ethanol.

Appearance of the product and contents of the container

Plastic bottle (polyethylene) equipped with a spray pump and cap.

Each bottle contains 30 milliliters of clear, colorless solution.

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: August 2022

Other sources of information

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