GINEDERMOFIX 500 MG VAGINAL TABLET

Introduction

Leaflet: information for the user

Ginedermofix 500 mg vaginal tablet

sertaconazole nitrate

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

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

• This medicine has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ginedermofix 500 mg vaginal tablet is and what it is used for
2. What you need to know before starting to use Ginedermofix 500 mg vaginal tablet
3. How to use Ginedermofix 500 mg vaginal tablet
4. Possible side effects

5 Conservation of Ginedermofix 500 mg vaginal tablet

1. Contents of the package and additional information

1. What Ginedermofix 500 mg vaginal tablet is and what it is 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 vaginal candidiasis (vaginal infection caused by a fungus called Candida).

2. What you need to know before starting to use Ginedermofix 500 mg vaginal tablet

Do not useGinedermofix

If you are allergic to sertaconazole or any of the other components 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 andGinedermofix

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

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 demonstrated, so your doctor will assess the use of 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 reported.

3. How to use Ginedermofix 500 mg vaginal tablet

Follow your doctor's instructions for administering Ginedermofix exactly. If in doubt, consult your doctor or pharmacist again.

The recommended dose is a single dose (1 vaginal tablet), preferably applied at night. A second dose, 1 to 2 weeks later, may be effective in patients with residual symptoms after a dose.

Adult and adolescent women

Ginedermofix is administered vaginally.

Instructions for correct administration of the preparation

Insert the tablet deeply with the disposable applicator into the vagina with the patient lying down and with the legs slightly flexed, preferably when going to bed.

Practical tips:

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

If you use more Ginedermofix than you should

The presentation 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.

4. Possible side effects

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

The side effects of this medicine are generally 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 also appear.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them 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 500 mg vaginal tablet

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiration date shown on the blister pack and carton after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the package and additional information

• Composition of Ginedermofix 500 mg vaginal tablet

-The active ingredient is sertaconazole nitrate.

Each tablet contains 500 mg of sertaconazole nitrate (equivalent to 437.5 mg of sertaconazole).

-The other ingredients are: glycerol dibehenate, corn starch, colloidal silicon dioxide, magnesium stearate, sodium carboxymethyl starch (type A) potato and microcrystalline cellulose.

Appearance of the product and contents of the package

Package of 1 vaginal tablet in Al/PVC blister pack and a disposable applicator.

Marketing authorization holder

Ferrer Internacional, S.A.

Gran Vía Carlos III- 94

08028 Barcelona- (Spain)

Manufacturer

Ferrel 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/).