Label: information for the user

Ginedermofix 2% vaginal cream

sertaconazole nitrate

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What is Ginedermofix 2% vaginal cream and what is it used for

2.What you need to know before starting to use Ginedermofix 2% vaginal cream

3.How to use Ginedermofix 2% vaginal cream

4.Possible adverse effects

5Storage of Ginedermofix 2% vaginal cream

6.Contents of the package and additional information

Ginedermofix belongs to a class of medications called imidazole antifungals(medications used to treat infections caused by fungi).

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

Do not useGinedermofix

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

Warnings and precautions

It is recommended to protect intimate clothing, due to the possibility of vaginal discharge.

Other medications and Ginedermofix

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

Use in elderly women

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

Use in girls

No information is available for this patient group.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Its safety has not been demonstrated in pregnant women or breastfeeding women, so your doctor will evaluate the use or non-use of this medication in this case.

It is not necessary to interrupt treatment during menstruation.

Driving and operating machines

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

Information on excipients

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

Follow exactly the administration instructions for Ginedermofix as 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 via the vagina.

Instructions for correct administration of the medication

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 slightly flexed legs, preferably before going to bed.

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

Practical tips:

The treatment should be accompanied by hygienic measures: washing with pH-neutral or alkaline soap, cotton clothing, avoiding vaginal douches.

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

If you use more Ginedermofix than you should

The presentation of Ginedermofix allows for the possibility of discarding local intravaginal application poisoning.

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.

If you forgot to use Ginedermofix

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, this medication may produce adverse effects, although not all people may experience them.

The adverse effects of this medication are generally mild and transient.

The most characteristic side effects are:

-Occasionally: genitourinary alterations (urethral burning sensation; rarely: vaginal itching, vaginitis, urinary incontinence, cystitis).

-Rarely, the following may appear: allergic/dermatological alterations (erythema, exanthematous eruptions, itching, contact dermatitis) and neurological alterations (headache).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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.

This medication does not require special conditions for conservation.

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

Do not use this medication after the expiration date that appears on the tube and on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and the medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medicines you no longer need. In this way, you will help protect the environment.

Composition of Ginedermofix 2% vaginal cream

- The active principle is sertaconazole nitrate.

Cada g of cream contains 20 mg of sertaconazole nitrate (equivalent to 17.5 mg of sertaconazole)

- The other components are: ethylene glycol stearate of palmitate and polyethylene glycol, saturated triglycerides of C10 to C18 polyoxylated and glycolized, mono-di-isostearate of glycerol, petroleum jelly, methyl parahydroxybenzoate (E-218), sorbic acid (E-200) and purified water.

Appearance of the product and contents of the packaging

Ginedermofix is presented in the form of a cream.

Cada envase contains a tube with 40 g of cream and 7 disposable vaginal applicators.

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 Buscallá, 1-9

08173 Sant Cugat del Vallés

Barcelona (Spain)

Date of the last review of this leaflet:May 2021

The detailed information of this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).