French pharmacy
MYCOHYDRALIN anti-fungal vaginal tablets 200MG
For warnings, precautions for use and contraindications, please see the instructions for use of MYCOHYDRALIN 200MG anti vaginal mycosis tablets.
Vulvovaginal yeast infection affects many women around the world. In fact, around 3 in 4 women have had vulvovaginal yeast infection at least once in their life *. Most often benign, they are difficult to live with. Fortunately, there are suitable treatments that allow effective treatment.
Commonly known as yeast infections, vaginal infections are extremely common. They represent 20% of the examinations carried out by the laboratories. The discomfort and pain are such that they sometimes force you to consult your pharmacist.
Once the infection is declared, the symptoms of vaginal yeast infection do not disappoint:
MycoHydralin® vaginal tablet contains clotrimazole , an active antifungal ingredient that effectively treats vaginal yeast infections with sensitive yeast, especially those with Candida albicans .
Administration of a tablet 3 consecutive evenings to place at the bottom of the vagina. The insertion can be done with or without an applicator.
In case of associated vulvar involvement, it is recommended to supplement vaginal treatment with the application of MycoHydralin® cream with clotrimazole 1% on the lesions.
Box of 3 MYCOHYDRALIN tablets for vaginal yeast infection
Does not leak: the tablet is dry.
Reduced size tablet
With applicator: easy and hygienic insertion, ensures a good location.
We advise you as a basic treatment, the Soothing and Reflective Balm Jailys recommended for all women who want to protect their privacy from external aggressions, who are looking for a global remedy, a lasting soothing, softer, more beautiful skin and mucous membranes. want to keep a healthy smell.
Please note, the MYCOHYDRALIN 200MG anti-yeast infection vaginal tablets is not a product like any other. Read the package leaflet of MYCOHYDRALIN for vaginal yeast infection carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 04/04/2017
MYCOHYDRALIN 200 Mg, Vaginal Tablet
clotrimazole
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· 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 experience no improvement or feel less well after 7 days.
1. What is MYCOHYDRALIN 200 Mg, Vaginal Tablet and in which cases it is used?
2. What should I know before using MYCOHYDRALIN 200 mg vaginal tablet?
3. How to use MYCOHYDRALIN 200 mg vaginal tablet?
4. What are the possible side effects?
5. How to store MYCOHYDRALIN 200 mg vaginal tablet?
6. Package contents and other information. I
1. WHAT MYCOHYDRALIN 200 MG, Vaginal Tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: imidazole derivatives - G01AF02
In case of associated vulvar infection, it is recommended to complete the vaginal treatment by applying a 1% clotrimazole cream to the lesions.
This medication is for adults only.
2. BEFORE YOU USE MYCOHYDRALIN 200 MG, Vaginal Tablet?
Never use MYCOHYDRALIN 200 mg, vaginal tablet:
· if you are allergic to the active substance (clotrimazole) or to any of the other ingredients of this medication mentioned in section 6.
This medication MUST NOT BE USED with a male condom or latex diaphragm.
Warnings and Precautions
DO NOT SWALLOW, TABLET MUST BE PLACED AT THE BOTTOM OF THE VAGIN
If you experience any of the following symptoms before or during the use of MYCOHYDRALIN 200 mg vaginal tablet, ask your doctor for advice:
· Fever, nausea, vomiting
· Low abdominal pain
· Back or shoulder pain
· Vaginal secretions with bad odors
· Vaginal haemorrhage
Talk to your doctor or pharmacist before using MYCOHYDRALIN 200 mg vaginal tablet.
In case of candidiasis, it is advised not to use a soap with acid pH (pH favoring the multiplication of Candida.
Vaginal douches should be avoided.
The use of internal buffers, spermicides, condoms or diaphragms should be avoided during treatment with Mycohydralin (risk of rupture of the condom or diaphragm)
It is recommended to avoid sexual intercourse in case of vaginal vulvar mycosis in order to reduce the risk of infection of the partner.
Your doctor may also treat your sexual partner to avoid recontamination.
Treatment may result in local burning sensations and increased itching. Generally, these phenomena yield spontaneously to the continuation of the treatment. If symptoms persist beyond 24 to 48 hours, consult your doctor.
Children and Youth
Not applicable.
Other medicines and MYCOHYDRALIN 200 mg vaginal tablet
Do not use with spermicidal products (risk of inactivation) or with a latex condom or diaphragm (risk of rupture of the condom or diaphragm).
Clotrimazole is likely to interact with the metabolism of Tacrolimus and Sirolimus. To prevent any risk of overdose with Tacrolimus or Sirolimus, tell your doctor or pharmacist before using Mycohydralin.
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MYCOHYDRALIN 200 Mg, vaginal tablet with food, drink and alcohol
Not applicable.
The use of MYCOHYDRALIN 200 mg vaginal tablet is possible during pregnancy. However, as a precautionary measure, it is best to avoid using the product during the first trimester of pregnancy.
During pregnancy and as a precautionary measure, use of the applicator is not recommended.
It is possible that clotrimazole passes into breast milk. As a precaution, breast-feeding should be discontinued for the duration of treatment. If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
3. HOW TO USE MYCOHYDRALIN 200 Mg, Vaginal Tablet?
This medication is for adults only.
Vaginal pathway
1 tablet to place at the bottom of the vagina 3 consecutive evenings.
In case of failure of this first treatment, a second identical cure can be prescribed.
If symptoms persist beyond 7 days, a medical consultation should be considered.
Application without applicator:
After thorough washing of the hands, deeply insert the tablet into the vagina, preferably in the extended position. The easiest way to do this is to lie down on your back with your knees folded away.
Use with applicator:
Use the applicator to introduce the tablet into the vagina preferably in the evening at bedtime.
If you have used more MYCOHYDRALIN 200 Mg, vaginal tablet than you should have
No cases of overdose have been reported to date.
If you forget to use MYCOHYDRALIN 200 mg vaginal tablet
Not applicable.
If you stop using MYCOHYDRALIN 200 Mg, Vaginal Tablet
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following adverse reactions have been reported after the commercialization of MYCOHYDRALIN, their frequency can not be determined on the basis of the available data:
• itching, redness, rash,
• vaginal irritation, burning sensation, swelling,
• decreased blood pressure, loss of awareness,
• feeling stifled,
• vaginal bleeding, local pain, discomfort,
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MYCOHYDRALIN 200 Mg Vaginal Tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding + 25 ° C.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What MYCOHYDRALIN 200 mg contains, vaginal tablet
· The active substance is:
Clotrimazole ................................................. .................................................. 200 mg
For a vaginal tablet
· The other ingredients are: lactose, corn starch, lactic acid, magnesium stearate, anhydrous colloidal silica, crospovidone, hypromellose, microcrystalline cellulose, calcium lactate.
What MYCOHYDRALIN 200 mg vaginal tablet looks like and contents of the pack
This medication is in the form of a vaginal tablet. Box of 3, 6, 30 or 60, or box of 3 vaginal tablets with applicator.
Marketing Authorization Holder
220 AVENUE OF RESEARCH
59120 LOOS
LA FRANCE
Marketing Authorization Operator
BAYER HEALTHCARE SAS
33 STREET OF INDUSTRY
74240 GAILLARD
LA FRANCE
51368 LEVERKUSEN
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
a / What is vulvo-vaginal mycosis?
Vulvovaginal mycoses are frequent infections of the mucous membranes in the intimate parts of the woman (vulva and vagina) caused most often by a fungus called Candida albicans. This fungus is naturally present in the body but certain factors can cause an abnormal proliferation of the fungus and lead to an infection. This imbalance of the vaginal flora results in vaginal mycosis that can be associated with mycosis of the vulva.
Factors that may favor the development of vulvo-vaginal mycosis are numerous:
· Taking certain medications: antibiotics, corticosteroids etc ...
· Diabetes
· Hormonal factors: hormonal contraception, menopause, pregnancy
· Inadequate hygiene
b / How to recognize vulvo-vaginal mycosis?
The main symptoms of vaginal mycosis are:
· itching
· Burning sensation of the intimate parts
· Loss of white color
· Pain during or after sexual intercourse
c / Advice on vulvo-vaginal mycosis:
Intimate toilet with a basic soap. Avoid acid soaps whose pH promotes the multiplication of candida albicans.
The use of internal buffers, spermicides, condoms or diaphragms should be avoided during treatment with Mycohydralin (risk of rupture of the condom or diaphragm).
It is recommended to avoid sexual intercourse in case of vulvo-vaginal mycosis in order to reduce the risk of infection of the partner.
d / Tips for preventing vulvo-vaginal mycosis:
Avoid too detergent soaps, excessive hygiene, vaginal douching and intimate sprays.
In order to avoid recontamination, the treatment of the sexual partner should be considered.
antifungal
clotrimazole
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
MYCOHYDRALIN 200 mg: vaginal tablet; box of 3 with applicator.
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MYCOHYDRALIN 500 mg: vaginal tablet; box of 1 with applicator.
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Laboratory
| p cp | p cp | |
| clotrimazole | 200 mg | 500 mg |
Usual dosage:
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