GINEDERMOFIX 500 MG VAGINAL TABLET
How to use GINEDERMOFIX 500 MG VAGINAL TABLET
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
Show originalContents of the leaflet
- Introduction
- What Ginedermofix 500 mg vaginal tablet is and what it is used for
- What you need to know before starting to use Ginedermofix 500 mg vaginal tablet
- How to use Ginedermofix 500 mg vaginal tablet
- Possible side effects
- Conservation of Ginedermofix 500 mg vaginal tablet
- Contents of the package and additional information
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:
- What Ginedermofix 500 mg vaginal tablet is and what it is used for
- What you need to know before starting to use Ginedermofix 500 mg vaginal tablet
- How to use Ginedermofix 500 mg vaginal tablet
- Possible side effects
5 Conservation of Ginedermofix 500 mg vaginal tablet
- 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/).
- Country of registration
- Average pharmacy price5.85 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to GINEDERMOFIX 500 MG VAGINAL TABLETDosage form: VAGINAL SEMISOLID, 2000 mgActive substance: sertaconazoleManufacturer: Ferrer Internacional S.A.Prescription requiredDosage form: VAGINAL SUPPOSITORY/CAPSULE/TABLET, 100 mg clotrimazoleActive substance: clotrimazoleManufacturer: Bayer Hispania S.L.Prescription requiredDosage form: VAGINAL SEMISOLID, 2% clotrimazole / 100 gActive substance: clotrimazoleManufacturer: Bayer Hispania S.L.Prescription required
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