DERMOFIX 20 mg/ml CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Dermofix 20 mg/ml Cutaneous Solution

Sertaconazole Nitrate

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Dermofix 20 mg/ml Cutaneous Solution and what is it used for
2. What you need to know before starting to use Dermofix 20 mg/ml Cutaneous Solution
3. How to use Dermofix 20 mg/ml Cutaneous Solution
4. Possible side effects
5. Storage of Dermofix 20 mg/ml Cutaneous Solution
6. Package Contents and Additional Information

1. What is Dermofix 20 mg/ml Cutaneous Solution and what is it used for

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

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

• Cutaneous candidiasis, infections that normally affect humid and warm areas of the skin and mucous membranes.
• Pityriasis versicolor, a disease characterized by the appearance of spots on the skin.
• Tinea, a disease that can affect the trunk (tinea corporis), groin (tinea cruris), feet (tinea pedis), hands (tinea manuum), and scalp (tinea barbae).

2. What you need to know before starting to use Dermofix 20 mg/ml Cutaneous Solution

Do not use Dermofix 20 mg/ml Cutaneous Solution

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/ml Cutaneous Solution.

Medication for external use only. Do not ingest.

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

Occlusive dressings should not be used after applying the medication, as they promote absorption into the skin.

Use of this medication should be discontinued if persistent irritation occurs in the treated area.

Children and Adolescents

There is no data available on the use of this medication in children, as no studies have been conducted in this age group.

Other Medications and Dermofix 20 mg/ml Cutaneous Solution

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

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

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 medication.

Since sertaconazole is not absorbed through the skin after topical application, pregnancy and breastfeeding are not contraindications for the use of sertaconazole cutaneous powder. However, its safety in pregnant or breastfeeding women has not been demonstrated, so your doctor will assess the use of this medication in these cases.

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

Driving and Using Machines

Since sertaconazole is not absorbed through the skin after topical application, it is not expected to affect your ability to drive or use machines.

3. How to use Dermofix 20 mg/ml Cutaneous Solution

Follow the instructions for administration of this medication indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

For cutaneous use.

Apply once or twice a day (preferably at night or morning and night) to the affected area, gently and uniformly, covering an additional portion 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 your hands 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 should consult your doctor.

It is essential to apply general hygiene and cleaning measures to avoid reinfection.

Follow the instructions for administration of the medication contained in this package leaflet or as indicated by your doctor. If you have any doubts, ask your doctor or pharmacist.

If you use more Dermofix 20 mg/ml Cutaneous Solution than you should

Overdose is unlikely to occur, as 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, 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 forget to use Dermofix 20 mg/ml Cutaneous Solution

Do not apply a double dose to make up for forgotten doses; continue with the usual schedule, and if you have forgotten many doses, consult your doctor or pharmacist immediately.

Dermofix 20 mg/ml Cutaneous Solution contains formaldehyde and ethanol

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

This medication contains alcohol (ethanol), which may cause a burning sensation on damaged skin.

4. Possible Side Effects

Like all medications, Dermofix 20 mg/ml Cutaneous Solution may cause side effects, although not everyone will experience them.

The active ingredient sertaconazole is not absorbed through the skin after application, so possible side effects only occur in the application area.

Common Side Effects(may affect up to 1 in 10 patients)

Skin disorders such as erythema, burning sensation/pruritus of the skin, and dryness of the skin

Uncommon Side Effects(may affect up to 1 in 100 patients)

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dermofix 20 mg/ml Cutaneous Solution

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 stated on the tube and carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dermofix 20 mg/ml Cutaneous Solution

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

Appearance of the Product and Package Contents

Plastic bottle (polyethylene) with a spray valve and cap.

Each bottle contains 30 milliliters of a 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 Last Revision of this Package Leaflet:August 2022

Other Sources of Information

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