GINEDERMOFIX 2% VAGINAL CREAM

Introduction

Package Leaflet: Information for the User

Ginedermofix 2% Vaginal Cream

sertaconazole nitrate

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Ginedermofix 2% Vaginal Cream and what is it used for
2. What you need to know before you use Ginedermofix 2% Vaginal Cream
3. How to use Ginedermofix 2% Vaginal Cream
4. Possible side effects

5 Conservation of Ginedermofix 2% Vaginal Cream

1. Package contents and additional information

1. What is Ginedermofix 2% Vaginal Cream and what is it used for

Ginedermofix belongs to a class of medicines called imidazole antifungals (medicines used to treat fungal infections).

Ginedermofix is indicated for the treatment of vulvovaginal candidiasis (vaginal infection caused by a fungus called Candida).

2. What you need to know before you use Ginedermofix 2% Vaginal Cream

Do not useGinedermofix

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

Warnings and precautions

It is recommended to protect your underwear due to the possibility of vaginal discharge.

Other medicines and Ginedermofix

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

Use in elderly women

No information is available in this patient group; however, no specific geriatric problems are expected.

Use in girls

No information is available in this patient group.

Pregnancy, breastfeeding, and fertility

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.

Its safety in pregnant or breastfeeding women has not been established, so your doctor will assess whether to use this medicine in this case.

It is not necessary to interrupt treatment during menstruation.

Driving and using machines

No effects on the ability to drive or use machines have been described.

Information on excipients

Ginedermofix contains methyl parahydroxybenzoate. It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

3. How to use Ginedermofix 2% Vaginal Cream

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

The recommended dose is one application per day (1 applicator with 5 g) for 7 days.

Adult and adolescent women

Ginedermofix is administered vaginally.

Instructions for the correct administration of the medicine

Instructions for using the single-use applicator:

- Place the applicator over the open tube (Figure A)

- Press the tube until the applicator is completely filled with cream (5 g of cream) (Figure B).

- Separate the applicator from the tube and close it.

It is recommended to insert the cream with the disposable applicator deeply into the vagina with the patient lying down and with the legs slightly flexed, preferably when going to bed.

Empty the applicator by slowly pressing the plunger. Remove the single-use applicator and discard it.

Practical tips:

Treatment should be accompanied by hygiene measures: washing with neutral or alkaline pH soap, cotton clothing, avoiding vaginal douches.

It is recommended to protect your underwear due to the possibility of vaginal discharge.

If you use more Ginedermofix than you should

The formulation of Ginedermofix allows the possibility of intoxication due to its local intravaginal application to be ruled out.

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.

If you forget to use Ginedermofix

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects of this medicine are, in general, mild and transient.

The most characteristic side effects are:

• Occasionally: genitourinary disorders (urethral burning sensation; rarely: vaginal pruritus, vaginitis, urinary incontinence, cystitis).
• Rarely, allergic/dermatological disorders (erythema, exanthematic eruptions, pruritus, contact dermatitis) and neurological disorders (headache) may appear.

Treatment should be discontinued immediately if the patient experiences any intense episode of headache, irritation, and/or hypersensitivity.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Ginedermofix 2% Vaginal Cream

This medicine does not require any special storage conditions.

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

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. Package contents and additional information

Composition of Ginedermofix 2% Vaginal Cream

- The active substance is sertaconazole nitrate.

Each gram of cream contains 20 mg of sertaconazole nitrate (equivalent to 17.5 mg of sertaconazole).

• The other ingredients are: ethylene glycol palmitostearate and polyethylene glycol, saturated C10 to C18 glycerides polyoxyethylenated and glycosylated, mono-di-isostearate of glycerol, vaseline oil, methyl parahydroxybenzoate (E-218), sorbic acid (E-200), and purified water.

Appearance of the product and package contents

Ginedermofix is presented as a cream.

Each package contains a tube with 40 g of cream and 7 disposable vaginal applicators.

Marketing authorization holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona - (Spain)

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 Sant Cugat del Vallés

Barcelona (Spain)

Date of the last revision of this leaflet:May 2021

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