Ginedermofix 500 mg vaginal tablet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ginedermofix 500 mg vaginal tablet

sertaconazole nitrate

Read the entire leaflet carefully before you start using 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 using Ginedermofix 500 mg vaginal tablet
3. How to use Ginedermofix 500 mg vaginal tablet
4. Possible adverse effects
5. How to store Ginedermofix 500 mg vaginal tablet
6. Contents of the pack and other information

1. What Ginedermofix 500 mg vaginal tablet 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 vaginal candidiasis (a 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 use Ginedermofix

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 intimate clothing, due to the possibility of vaginal discharge.

Other medicines and Ginedermofix

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 menstrual periods.

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 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), preferably administered at night. A second dose, 1 to 2 weeks later, may be effective in patients who still have residual symptoms after the first dose.

Adult women and adolescents

Ginedermofix is administered by vaginal route.

Instructions for correct administration of the preparation

Insert the tablet deeply into the vagina using the disposable applicator, with the patient lying down and legs slightly bent, preferably at bedtime.

Practical advice:

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

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, stating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 reactions (erythema, exanthematous eruptions, pruritus, contact dermatitis) and neurological disturbances (headache) may also occur.

Treatment must be discontinued immediately if the patient experiences a 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 can 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 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 expiry date stated on the blister and the outer carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines should 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 package and other information

• Composition of Ginedermofix 500 mg vaginal tablet

• The active substance is sertaconazole nitrate.

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

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

Appearance of the product and contents of the package

Pack containing 1 vaginal tablet in an Al/PVC blister and one 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 most recent revision of this leaflet: May 2021

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