Patient Information Leaflet

Ginedermofix 500 mg vaginal tablet

Sertaconazole nitrate

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Ginedermofix 500 mg vaginal tablet and what it is used for

2.What you need to know before you start taking Ginedermofix 500 mg vaginal tablet

3.How to use Ginedermofix 500 mg vaginal tablet

4.Possible side effects

5Storage of Ginedermofix 500 mg vaginal tablet

6.Contents of the pack and additional information

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

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

Do not useGinedermofix

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

Warnings and precautions

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

Other medicines andGinedermofix

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

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, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

It is not necessary to interrupt treatment during menstruation.

Driving and operating machines

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

Follow exactly the administration instructions for Ginedermofix as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Adult and adolescent women

Ginedermofix is administered via the vaginal route.

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 slightly flexed legs, preferably before going to bed.

Practical tips:

The treatment should be accompanied by hygienic 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 for the possibility of discarding the risk of intoxication following its local intravaginal application.

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.

Like all medications, this medication may produce adverse effects, although not everyone will 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 pruritus, vaginitis, urinary incontinence, cystitis.

-Rarely, allergic/dermatological alterations (erythema, exanthematous eruptions, pruritus, contact dermatitis) and neurological alterations (headache) may also appear.

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 pharmacistorpharmacist, even if it is a possible adverse effect that does not appear 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 blister and on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications that you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. By doing so, you will help protect the environment.

-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 components are: dibehenato of glycerol, cornstarch, colloidal silicon dioxide, magnesium stearate, sodium carboxymethyl starch (type A) from potato, and microcrystalline cellulose.

Appearance of the product and contents of the packaging

Packaging of 1 vaginal tablet in an Al/PVC blister and a disposable applicator.

Marketing authorization holder

Ferrer Internacional, S.A.

Gran Vía Carlos III- 94

08028 Barcelona- (Spain)

Responsible for manufacturing

Ferrel Internacional, S.A.

Joan Buscallá, 1-9

08173 Sant Cugat del Vallés

Barcelona (Spain)

Last review date 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/).