NOTICE
ANSM - Updated on : 08/04/2024
Product name
CANDAZOL 300 mg, ovule
Sertaconazole nitrate
Box
Please read this leaflet carefully before using this medicine. It contains important information for your treatment.
If you have any further questions, please ask your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- If you need more information or advice, ask your pharmacist.
- If symptoms worsen or persist, consult a doctor.
- If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
What does this leaflet contain?
1. What is CANDAZOL 300 mg, ovule and what is it used for?
2. What do I need to know before taking CANDAZOL 300 mg, ovule?
3. How do I use CANDAZOL 300 mg, ovule?
4. What are the possible side effects?
5. How do I keep CANDAZOL 300 mg, ovule?
6. Package contents and other information.
1. WHAT IS CANDAZOL 300 mg, ovule AND WHAT IS IT USED FOR?
LOCAL ANTIFUNGAL AGENT.
(G: genito-urinary system and sex hormones)
This drug is indicated for the local treatment of candidiasis (disorders caused by microscopic fungi) of the vagina.
2. WHAT DO I HAVE TO KNOW BEFORE USING CANDAZOL 300 mg, ovule?
Never use CANDAZOL 300 mg, ovule in the following cases:
- if you are allergic to any component of the product or to a related substance,
- if used with male condoms and latex diaphragms.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Special warnings
Local treatment of mycosis is only part of the treatment. To avoid relapses, it is essential that your doctor check for any factors that may be contributing to a relapse.
Precautions for use
- Do not use acid soap for local hygiene (acidity encourages the proliferation of fungi)(see How to use CANDAZOL, ovule).
- This treatment may cause local burning and increased itching. These symptoms usually subside spontaneously with continued treatment. If symptoms persist for more than 24 to 48 hours, consult your doctor.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Other medicines and CANDAZOL 300 mg, ovule
Do not use with spermicidal products (risk of inactivation).
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICATIONS, ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT YOU ARE TAKING.
CANDAZOL 300 mg, ovule with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
This medicine should only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor, who is the only person who can judge whether it is necessary to continue treatment.
As a general rule, always ask your doctor or pharmacist for advice before taking any medication during pregnancy or while breast-feeding.
Sportsmen
Not applicable.
Driving and use of machinery
Not applicable.
CANDAZOL 300 mg, ovule contains
Not applicable.
3. HOW TO USE CANDAZOL 300 mg, ovule?
Dosage
One ovule as a single administration, in the evening at bedtime.
Method and route of administration
Vaginal route. Insert one ovule deep into the vagina, preferably in the supine position. The easiest way is to lie on your back, with your knees bent and spread apart.
Practical advice
- wash with a pH-neutral or alkaline soap,
- to avoid contaminating those around you, use your own towels and washcloths,
- your doctor can :
o also treat your sexual partner, to prevent him or her from contaminating you again,
o prescribe a topical antifungal treatment.
- wear cotton underwear,
- avoid wearing internal tampons during treatment,
- avoid douching,
- treatment possible during menstruation.
Frequency of administration
The ovule should preferably be administered in the evening at bedtime.
Duration of treatment
Theoretically, treatment lasts 1 day.
However, if clinical signs persist, your doctor may prescribe a second ovule at 7-day intervals.
If you have used more CANDAZOL 300 mg, ovule than you should have :
Excessive use may lead to a worsening of undesirable effects. If you have taken more CANDAZOL, ovule than you should have and you experience any side effects not mentioned in this leaflet, please consult your doctor.
If you forget to use CANDAZOL 300 mg, ovule :
Not applicable.
If you stop using CANDAZOL 300 mg, ovule :
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, CANDAZOL, ovule is likely to have undesirable effects, although not everyone is subject to them.
- local burning sensation, itching of no consequence and possible allergy.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE CANDAZOL 300 mg, ova?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging or blister. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What CANDAZOL 300 mg, ovule contains
- The active substance is :
Sertaconazole nitrate ................................................................................................ 0.300 g
For one ovule.
- The other components are :
Solid hemi-synthetic glycerides (WITEPSOL H19), solid hemi-synthetic glycerides (SUPPOCIRE NAI 50), anhydrous colloidal silica.
What CANDAZOL 300 mg, ovule is and what it contains
This medicine comes in the form of an ovule. Box of 1 or 2 ovule(s).
Marketing authorization holder
BESINS HEALTHCARE FRANCE
3 rue du bourg labbe
75003 paris
Marketing authorization holder
BESINS HEALTHCARE FRANCE
17 rue PERIER
92120 MONTROUGE
Manufacturer
UNITHER LIQUID MANUFACTURING
1-3 ALLEE DE LA NESTE
ZI D'EN SIGAL
31770 COLOMIERS
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.