Package Insert: Information for the User

Dermofix 20 mg/ml Topical Solution

Sertaconazole nitrate

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

• Keep this package insert, 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 package insert. 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).

Do not use Dermofix 20 mg/ml topical solution

If you are allergic to sertaconazole, imidazoles in general, or to 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 topical solution.

For external use only. Do not ingest.

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

Do not use occlusive dressings after applying the medication, as this may enhance skin absorption.

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

Children and adolescents

No data are available on the use in children, as there are no studies in this age group.

Other medications and Dermofix 20 mg/ml topical 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 Dermofix topical powder use.

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 topical powder. However, its safety has not been demonstrated in pregnant women or breastfeeding women, and your doctor will evaluate the use or non-use of this medication in this case.

Breastfeeding is not contraindicated, but the medication should be avoided on the nipple area.

Driving and operating machinery

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

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

Topical use.

Apply one or two times a day (preferably at night or morning and night), on 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.

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

It is unlikely that you will experience intoxication due to the fact that 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/ml topical solution

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

Dermofix 20 mg/ml topical 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). It may cause a burning sensation on injured skin.

Like all medications, Dermofix 20 mg/ml topical solution may cause adverse effects, although not everyone will experience them.

The active ingredient sertaconazole is not absorbed after its application to the skin, so any possible adverse effects will only occur in the application area.

Adverse effects are limited to the area of application.

Frequent Adverse Effects(may affect up to 1 in 10 patients)

Cutaneous alterations such aserythema, sensation of burning/itching localized skin and skin dryness

Rare Adverse Effects(may affect up to 1 in 100 patients)

Cutaneous alterations such ascontact dermatitis (skin redness after direct contact with a substance).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctororpharmacist, 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/ml topical solution

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

Appearance of the product and contents of the packaging

Plastic bottle (polyethylene) provided with a nebulizing valve and stopper.

Each bottle contains 30 milliliters of transparent and colorless solution.

Holder of the marketing authorization

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:August 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)