Ginedermofix 2% vaginal cream

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Ginedermofix 2% vaginal cream

sertaconazole nitrate

Read the entire leaflet carefully before you start using 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.

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

Leaflet contents:

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

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

3. How to use Ginedermofix 2% vaginal cream

4. Possible side effects

5. How to store Ginedermofix 2% vaginal cream

6. Contents of the pack and other information

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

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

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

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

Do not use Ginedermofix

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

Warnings and precautions

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

Other medicines and Ginedermofix

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Use in elderly women

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

Use in girls

There is no available information in 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.

Its safety in pregnant or breastfeeding women has not been established; therefore, your doctor will assess whether or not this medicine should be used in such cases.

There is no need to interrupt treatment during menstruation.

Driving and using machines

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

Information about 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 for Ginedermofix as indicated by your doctor. If in doubt, please consult your doctor or pharmacist again.

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

Adult women and adolescents

Ginedermofix is administered vaginally.

Instructions for correct administration of the medicine

Instructions for using the single-use applicator:

• Place the applicator onto the open tube (Figure A).
• Squeeze the tube until the applicator is completely filled with cream (5 g of cream) (Figure B).
• Separate the applicator from the tube and close the tube.

It is recommended to insert the cream deeply into the vagina using the disposable applicator while lying down with knees slightly bent, preferably before going to bed.

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

Practical advice:

The treatment should be accompanied by hygienic measures: washing with neutral or alkaline pH soap, wearing cotton underwear, and avoiding vaginal douching.

It is advisable to protect intimate clothing due to the possibility of vaginal drainage.

If you use more Ginedermofix than you should

The formulation of Ginedermofix rules out the possibility of intoxication following local intravaginal application.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses. Continue with your regular dosing schedule. If you have missed several doses, consult your doctor or pharmacist immediately.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

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

The most characteristic side effects are:

• Occasionally: genitourinary disturbances (urethral burning sensation; rarely: vaginal pruritus, vaginitis, urinary incontinence, cystitis).
• Rarely: allergic/dermatological disturbances (erythema, exanthematous rashes, pruritus, contact dermatitis) and neurological disturbances (headache).

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 stated on the tube and the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 components are: ethylene glycol palmitostearate and polyethylene glycol, polyoxyethylene and glycolized saturated C10-C18 glycerides, glycerol mono-di-isostearate, vaseline oil, methyl parahydroxybenzoate (E-218), sorbic acid (E-200), and purified water.

Appearance of the product and contents of the pack

Ginedermofix is presented as a cream.

Each package contains one 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 most recent revision of this leaflet: May 2021

Detailed information on 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/).