DERMOFIX 20 mg/g CUTANEOUS POWDER

Introduction

Package Leaflet: Information for the User

Dermofix 20 mg/g Cutaneous Powder

Sertaconazole Nitrate

Read all of this 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Dermofix 20 mg/g Cutaneous Powder and what is it used for
2. What you need to know before you use Dermofix 20 mg/g Cutaneous Powder
3. How to use Dermofix 20 mg/g Cutaneous Powder
4. Possible side effects
5. Storage of Dermofix 20 mg/g Cutaneous Powder
6. Contents of the pack and further information

1. What is Dermofix 20 mg/g Cutaneous Powder and what is it 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 humid and warm areas of the skin and mucous membranes.
• Pityriasis versicolor, a disease characterized by the appearance of scattered patches 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 you use Dermofix 20 mg/g Cutaneous Powder

Do not use Dermofix

If you are allergic to sertaconazole, imidazoles in general, or 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 Cutaneous Powder.

Medicine for external use only. Do not ingest.

Contact with the eyes and mucous membranes should be avoided. In case of accidental contact, rinse your eyes with plenty of water.

The use of occlusive dressings after applying the medicine is not recommended, as it favors absorption into the skin.

The use of this medicine should be discontinued if persistent irritation occurs in the treated area.

Children and Adolescents

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

Other Medicines and Dermofix 20 mg/g Cutaneous 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 the use of Dermofix Cutaneous Powder.

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

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 medicine.

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 medicine in these cases.

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

Driving and Using Machines

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

3. How to use Dermofix 20 mg/g Cutaneous Powder

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

For cutaneous use.

Apply once or twice a day (preferably at night or morning and night), over the affected area in a gentle and uniform manner, trying to cover an additional portion of approximately 1 centimeter of healthy skin around the affected area.

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

The usual duration of treatment is 3 to 4 weeks.

If the 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 exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

If you use more Dermofix 20 mg/g Cutaneous Powder than you should

Overdose 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, phone 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 Cutaneous Powder

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.

4. Possible Side Effects

Like all medicines, Dermofix 20 mg/g Cutaneous Powder can cause side effects, although not everybody gets them.

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

Very Rare Side Effects(may affect up to 1 in 10,000 patients)

Skin disorders such as a burning sensation/itching of the skin and contact dermatitis (redness of the skin after direct contact with a substance).

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dermofix 20 mg/g Cutaneous Powder

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

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Dermofix 20 mg/g Cutaneous Powder

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

Appearance of the Product and Contents of the Pack

Plastic bottle (polyethylene) with a stopper and 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)

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès (Barcelona)

Spain

Date of Last Revision of this Leaflet:August 2022

Other Sources of Information

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