NOTICE
ANSM - Updated on : 16/01/2025
Name of medicinal product
CLOTRIMAZOLE EG LABO CONSEIL 1%, cream
Clotrimazole
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 7 days.
What does this leaflet contain?
1. What CLOTRIMAZOLE EG LABO CONSEIL 1%, cream is and what it is used for
2. What do I need to know before using CLOTRIMAZOLE EG LABO CONSEIL 1%, cream?
3. How do I use CLOTRIMAZOLE EG LABO CONSEIL 1%, cream?
4. What are the possible side effects?
5. How to store CLOTRIMAZOLE EG LABO CONSEIL 1%, cream?
6. Package contents and other information.
1. WHAT IS CLOTRIMAZOLE EG LABO CONSEIL 1%, cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: LOCAL ANTIFUNGAL (G: Genitourinary system and sex hormones).
This drug is indicated for the treatment of vulvar damage caused by sensitive vulvovaginal yeast mycoses (diseases caused by microscopic fungi).
This medicine is for adults only.
Consult your doctor if you do not feel any improvement or if you feel worse after 7 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING CLOTRIMAZOLE EG LABO CONSEIL 1%, cream?
Never use CLOTRIMAZOLE EG LABO CONSEIL 1%, cream:
- if you are allergic (hypersensitive) to imidazole derivatives or to any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using CLOTRIMAZOLE EG LABO CONSEIL 1%, cream:
- Avoid application near the eyes. Do not swallow. Keep out of sight and reach of children.
- In the event of application to damaged skin, it is essential to follow the recommendations and dosage indicated by your doctor, as the product penetrates the skin in these circumstances.
- If you experience any of the following symptoms before or during use of CLOTRIMAZOLE EG LABO CONSEIL, please consult your doctor:
o fever, nausea, vomiting,
o lower abdominal pain,
o back or shoulder pain,
o vaginal secretionswith unpleasant odors,
o vaginal bleeding.
- In cases of candidiasis, we advise against the use of soaps with an acid pH (pH favoring Candida multiplication).
- Vaginal douching should be avoided.
- The use of internal tampons, spermicides, condoms or diaphragms should be avoided during treatment with CLOTRIMAZOLE EG LABO CONSEIL, cream (risk of condom or diaphragm rupture).
- Sexual intercourse should be avoided in cases of vulvovaginal mycosis to reduce the risk of infection to your partner.
- Your doctor may also treat your sexual partner to prevent recontamination.
- Treatment may cause local burning and increased itching. These symptoms generally subside spontaneously with continued treatment. If symptoms persist for more than 24 to 48 hours, consult your doctor.
Children and adolescents
Not applicable.
Other medicinal products and CLOTRIMAZOLE EG LABO CONSEIL 1%, cream
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CLOTRIMAZOLE EG LABO CONSEIL 1%, cream with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacistfor advicebefore taking this medicine.
CLOTRIMAZOLE EG LABO CONSEIL may be used during pregnancy if prescribed by your doctor.
CLOTRIMAZOLE EG LABO CONSEIL may be used during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and use of machinery
Not applicable.
CLOTRIMAZOLE EG LABO CONSEIL 1%, cream contains cetostearyl alcohol and benzyl alcohol.
This medicine contains cetostearyl alcohol and may cause local skin reactions (e.g. contact dermatitis).
This product contains 30 mg benzyl alcohol per 1g of cream. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause slight local irritation.
3. HOW DO I TAKE CLOTRIMAZOLE EG LABO CONSEIL 1%, cream?
Always use this medicine exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Method and route of administration
Do not swallow.
The product should be used 2 times a day, after careful cleansing and drying of the lesions to be treated.
Duration of treatment
Treatment lasts 1 week.
Regular use of the product throughout the treatment period is crucial to its success.
If symptoms persist beyond 7 days, medical advice should be sought.
If you have used more CLOTRIMAZOLE EG LABO CONSEIL 1%, cream than you should have
No case of overdose has been reported to date.
An overdose, following a single cutaneous application (application over a large area and in conditions favorable to absorption) or through undesired oral ingestion, is unlikely.
There is no specific antidote.
If you forget to use CLOTRIMAZOLE EG LABO CONSEIL 1%, cream
Not applicable.
If you stop using CLOTRIMAZOLE EG LABO CONSEIL 1%, cream
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but these do not always occur in everyone.
The following adverse reactions have been reported following the marketing of CLOTRIMAZOLE; their frequency cannot be defined on the basis of available data:
- allergic reactions: anaphylactic shock, angioedema,
- skin reactions: itching, redness, rash,
- at the application site: irritation, swelling or redness, pain,
- drop in blood pressure, loss of consciousness,
- sensation of shortness of breath,
- vaginal discharge, vaginal bleeding,
- vulva and vagina: pain, discomfort, itching, redness, burning sensation,
- abdominal pain, nausea.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. 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: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE CLOTRIMAZOLE EG LABO CONSEIL 1%, cream?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
No special storage precautions are required.
Shelf life after opening: 6 months.
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. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What CLOTRIMAZOLE EG LABO CONSEIL 1% cream contains
- The active substance is :
Clotrimazole............................................................................................................................ 1.0 g
For 100 g of cream.
- The other excipient components are :
Sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water.
What CLOTRIMAZOLE EG LABO CONSEIL 1% cream is and what it contains
This medicine comes in the form of a cream in a 20 g tube.
Marketing authorization holder
EG LABO LABORATOIRES EUROGENERICS
central park
9-15 rue maurice mallet
92130 issy les moulineaux
Marketing authorization holder
EG LABO LABORATOIRES EUROGENERICS
central park
9-15 rue maurice mallet
92130 issy les moulineaux
Manufacturer
LABORATORIOS BASI - INDUSTRIA FARMACEUTICA, S.A
PARQUE INDUSTRIAL MANUEL LOURENCO FERREIRA, LOTES 8, 15 e 16,
3450-232 MORTAGUA
Portugal
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.
Health education advice :
What is vulvovaginal mycosis?
Vulvovaginal mycoses are frequent infections of the mucous membranes of a woman's private parts (vulva and vagina), most often caused by a fungus called Candida albicans. This fungus is naturally present in the body, but certain factors can cause the fungus to proliferate abnormally, leading to infection. This imbalance in vaginal flora results in vaginal mycosis, which can be associated with vulvar mycosis.
There are many factors that can contribute to the development of vulvovaginal mycosis:
- Taking certain medications: antibiotics, corticoids, etc.
- Diabetes
- Hormonal factors: hormonal contraception, menopause, pregnancy
- Unsuitable hygiene
How to recognize vulvovaginal mycosis?
The main symptoms of vaginal mycosis are as follows:
- Itching
- Burning sensation in intimate parts
- White discharge
- Pain during or after intercourse
Advice on vulvovaginal mycoses :
- Intimate cleansing with a basic soap. Avoid acidic soaps, whose pH promotes the multiplication of Candida albicans.
- The use of internal tampons, spermicides, condoms or diaphragms should be avoided during treatment with CLOTRIMAZOLE EG LABO CONSEIL (risk of condom or diaphragm rupture).
- Sexual intercourse should be avoided in cases of vulvovaginal mycosis to reduce the risk of infection to the partner.
Tips to avoid vulvovaginal mycosis:
- Avoid over-detergent soaps, excessive hygiene, douches and intimate sprays.
- To avoid recontamination, consider treating the sexual partner.