MYCOHYDRALIN anti-fungal vaginal tablets 200MG

MYCOHYDRALIN anti-fungal vaginal tablets 200MG View larger

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Hydralin Hydralin

MYCOHYDRALIN anti-fungal vaginal tablets 200MG

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Partners with: LACTIBIANE CND PILEJE 5M COMFORT INTIMATE, PILEJE LACTIBIANE CND 10M COMFORT INTIMATE 14 CAPSULES, Flora Vaginal Hydralin 10 Capsules, Feminabiane Vaginal Flora 7 Vaginal Tablets

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MYCOHYDRALIN anti-fungal vaginal tablets 200MG

For warnings, precautions for use and against-indications, please refer to the manual of MYCOHYDRALIN anti-fungal vaginal tablets 200MG.

Vulvovaginal mycoses affect many women worldwide. Indeed, about 3 out of 4 women had vulvovaginal yeast infection at least once in their lives. * Usually benign, they are nevertheless difficult to live. Fortunately, there are appropriate treatments to heal effectively.

Description MYCOHYDRALIN 200MG anti-fungal vaginal tablets

Commonly known fungal infections, vaginal infections are extremely common. They represent 20% of the examinations performed by the laboratory. The discomfort and pain are such that they require some time to consult their pharmacist.

Once declared infection, the symptoms of yeast infection are unmistakable:

permanent itching of the vulva and the vagina
thick and creamy white discharge
Vaginal burning during urination
sex more painful
Vulva swollen and bright red.

MYCOHYDRALIN indication of vaginal tablets

MycoHydralin® vaginal tablet contains clotrimazole, an antifungal active ingredient that is effective in treating yeast infections sensitive yeast, including Candida albicans.

Directions for use and dosage of MYCOHYDRALIN vaginal mycosis

Administration of a tablet 3 consecutive nights to place in the vagina. The insertion can be made with or without an applicator.

Breach associated vulvar, it is recommended to complete the vaginal treatment by applying MycoHydralin® cream clotrimazole 1% of the lesions.

Presentation

Box of 3 tablets MYCOHYDRALIN vaginal mycosis

Does not flow: the tablet is dry.
smaller tablet
With applicator: Easy and hygienic insertion, provides a good location.

Warnings about medications

Attention drug MYCOHYDRALIN 200MG anti-fungal vaginal tablets is not a product like any other. Read the package leaflet before ordering. Do not let the drug out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Tell your pharmacist Online ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual of this drug on the website of the National Agency for Medicines Safety and Health Products.

Pharmacovigilance : Declare one or effect (s) undesirable (s) connected (s) to the use of a drug

VIDAL OF THE FAMILY

MYCOHYDRALIN Vaginal Tablet

antifungal

clotrimazole

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

MYCOHYDRALIN 200 mg: vaginal tablet; box of 3 with applicator.
-

MYCOHYDRALIN 500 mg: vaginal tablet; box of 1 with applicator.
-

Laboratory

COMPOSITION (summary)
p cp p cp
clotrimazole 200 mg 500 mg

INDICATIONS (summary)
This gynecological tablet contains an antifungal agent of the imidazole family.
It is used in the local treatment of mycosis of the vagina, especially candidiasis .
CONTRAINDICATIONS (summary)
This medication should not be used if you are allergic to imidazole .
WARNING (Contents)
This medication is available without a prescription. It can be used on the advice of your pharmacist if vaginal mycosis symptoms recur, such as itching, burning, vaginal pain during sexual intercourse, white discharge. Nevertheless, it is best to consult a doctor in the following situations:
  • fever, nausea, vomiting;
  • vaginal bleeding, malodorous white discharge;
  • back pain, abdominal pain;
  • if this is your first infection.
If symptoms persist after 7 days, see your doctor.
Do not use a latex condom or diaphragm as a contraceptive during treatment: risk of rupture of the condom or diaphragm due to alteration of the latex.
DRUG INTERACTIONS (summary)
Like any vaginal treatment, this drug may decrease the contraceptive effectiveness of spermicidal creams and ovules.
Inform your doctor or pharmacist if you are taking a medication containing tacrolimus or sirolimus.
PREGNANCY AND BREAST-FEEDING (summary)
The effect of this medication during pregnancy or lactation is not well known. The assessment of the possible risk associated with its use is individual: ask your pharmacist or doctor for advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
The tablet should be inserted deep into the vagina, using the supplied applicator, preferably in the evening at bedtime.
To make it easier, it is recommended to proceed in lying on the back, knees folded. Stay elongated for 5 to 10 minutes after inserting the tablet.

Usual dosage:

  • Female adult: 1 tablet 200 mg daily for 3 consecutive days or 1 500 mg tablet in a single dose (if the symptoms persist beyond 3 days, a second 500 mg tablet may be used).
TIPS (summary)
Wash applicator with hot water after application.
In the event of vaginal dryness, the tablet may not fully disintegrate.
During menstruation, do not stop treatment and avoid wearing tampons.
In case of recurrent gynecological fungi ( candidiasis ), it is useful to respect the usual advice to prevent the abnormal development of candida albicans and other microscopic fungi:
  • limiting the use of antibiotics to conditions requiring their use. Indeed, fungi are destroyed by certain bacteria , themselves killed by antibiotics;
  • fight against moisture, conducive to the development of mushrooms: dry well before putting on his underwear, prefer cotton panties that absorb better perspiration, do not keep his swimsuit after swimming in swimming pool, avoid the harbor clothing too tight;
  • change internal or external protections frequently during menstruation;
  • avoid using acid soaps: they promote the multiplication of fungi.
Your partner may be contaminated with no symptoms . A medical consultation is necessary to discuss the benefits of treatment.
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
POSSIBLE ADVERSE EFFECTS (summary)
Aggravation of burns and itching at the beginning of treatment: these symptoms reflect the destruction of the microscopic fungi that release an irritating substance.
Rash, discomfort, shortness of breath, hypotension, vaginal bleeding, stomach pain, discomfort.


GLOSSARY (summary)


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


antibiotics
A substance capable of blocking the multiplication of certain bacteria or killing them. The spectrum of an antibiotic is the set of bacteria on which this product is usually active. Unlike bacteria, viruses are not susceptible to antibiotics. The first antibiotics were extracted from mushroom cultures: penicillium (penicillin), streptomyces (streptomycin). They are currently manufactured by chemical synthesis. Antibiotics are divided into families: penicillins, cephalosporins, macrolides, tetracyclines (cyclines), sulphonamides, aminoglycosides, lincosanides, phenicolates, polymyxins, quinolones, imidazoles, etc.
Inappropriate use of antibiotics may lead to the development of resistance: use antibiotics only on medical prescription, adhere to its dosage and duration, do not give or advise another person an antibiotic prescribed for you .


antifungal
Medication that destroys fungi and microscopic yeasts. These can be present on the skin or the mucous membranes (digestive tract or genital organs). The most common yeast is Candida albicans.


bacteria
Microscopic organism that can cause infections. Unlike viruses, bacteria are usually susceptible to antibiotics.


candidiasis
Abnormal multiplication of a microscopic yeast, Candida albicans most often. This is a frequent and benign complication of antibiotic treatments. The main symptoms are digestive disorders, a brown or black color of the tongue, white spots on the palate or tongue (thrush), itching or burning of the vulva or glans.


imidazole
A family of medicines that includes antifungals, antibiotics and antiparasitics.


mycoses
Affection due to microscopic fungi, favored by the taking of antibiotics.


symptoms
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 04/04/2017

Name of the medicinal product

MYCOHYDRALIN 200 Mg, Vaginal Tablet

clotrimazole

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

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.

What is in this leaflet?

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

This medication is indicated for the treatment of sensitive yeast vaginal mycosis (microscopic fungal diseases).

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.

Pregnancy and breast feeding

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.

1- Remove the applicator from its packaging. Pull piston (A) up to the stop. Remove the tablet from its blister pack and press it 1 cm into the applicator (B) so that the rounded part of the tablet is on the outside of the applicator.

2- Place the applicator at the entrance of the vaginal opening and then insert it deep 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.

3- Hold the applicator in this position and then press the plunger (A) so that the tablet is placed in the vagina.

Gently remove the applicator.

4- After use, clean the applicator thoroughly with hot water (not boiling).

To do this, completely remove the stem A from the applicator B, beyond the stop.

The applicator should not be thrown into the toilet.

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

BAYER HEALTHCARE SAS

220 AVENUE OF RESEARCH

59120 LOOS

LA FRANCE

Marketing Authorization Operator

BAYER HEALTHCARE SAS

33 STREET OF INDUSTRY

74240 GAILLARD

LA FRANCE

Maker

BAYER AG

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]

Other

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.

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Hydralin is used for personal hygiene. Use Gyn Hydralin or Hydralin Apaisa depending on the circumstances. Applied as a liquid soap and rinse gently .It is advisable to consult a doctor if symptoms persist.

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