Package Insert: Information for the User

Dermofix 20 mg/g Topical Powder

Sertaconazole Nitrate

Read this 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 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

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/g topical powder.

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 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 for use in children, as there are no studies in this age group.

Other medications and Dermofix 20 mg/g topical powder

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 are not contraindications for the use of sertaconazole topical powder. However, its safety has not been demonstrated in pregnant women or breastfeeding women, so your doctor will evaluate whether to use this medication in these cases.

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 in the morning and at night), gently and uniformly over the affected area, also covering 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 should 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 as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

If you use more Dermofix 20 mg/g topical powder than you should

It is unlikely to cause 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 topical powder

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.

Like all medications, Dermofix 20 mg/g topical powder may produce adverse effects, although not all people will experience them.

The active ingredient sertaconazole does not get absorbed after its application on the skin, so possible adverse effects occur only in the application area.

Adverse effects of very rare frequency(may affect up to 1 in10,000 patients)

Cutaneous alterations such aslocal skin burning/itching sensation and contact 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 about possible adverse effects that do not appear in this leaflet. 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.

Store in a cool and dry place. Protect from light.

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 medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Dermofix 20 mg/g topical powder

• The active ingredient is sertaconazole nitrate. Each gram of topical powder contains 20 mg of sertaconazole nitrate.
• The other components are: titanium dioxide (E-171), kaolin, and talc.

Appearance of the product and contents of the packaging

Plastic bottle (polyethylene) with a stopper and a screw cap containing a white or almost white powder.

Each bottle contains 30 grams of powder.

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: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)