1. WHAT IS MYCOHYDRALIN 500 mg, vaginal tablet AND WHAT IS IT USED FOR?
LOCAL ANTIFUNGAL (G: Genitourinary system and sex hormones).
This medicine is indicated for the treatment of sensitive vaginal yeast mycoses (conditions caused by microscopic fungi).
In the case of associated vulvar damage, it is recommended to complete the vaginal treatment by applying a 1% clotrimazole cream to the lesions.
This medicine is for adults only.
You should contact your doctor if you do not feel any improvement or if you feel less well after 7 days.
2. WHAT YOU SHOULD KNOW BEFORE USING MYCOHYDRALIN 500 mg, vaginal tablet
Never use MYCOHYDRALIN 500 mg, vaginal tablet:
ifyou are allergic to the active substance or to any of the other components contained in this medicine, as mentioned in section 6.
This medicine MUST NOT BE USED with a male condom or a latex diaphragm.
Warnings and Precautions
Talk to your doctor or pharmacist before using MYCOHYDRALIN 500 mg, vaginal tablet
Warnings
DO NOT SWALLOW, THE TABLET SHOULD BE PLACED DEEP INSIDE THE VAGINA.
If you experience any of the following symptoms before or during the use of MYCOHYDRALIN 500 mg, vaginal tablet, please seek advice from your doctor:
Fever, nausea, vomiting
Lower abdominal pain
Back or shoulder pain
Vaginal secretions with bad odour
Vaginal bleeding
Precautions for use
In case of candidiasis, it is not recommended to use a soap with an acidic pH (pH favouring the multiplication of Candida).
Vaginal douches should be avoided.
The use of internal tampons, spermicides, condoms or diaphragms should be avoided during treatment with MYCOHYDRALIN 500 mg, vaginal tablet (risk of condom or diaphragm rupture).
It is recommended that sexual intercourse be avoided in cases of vulvovaginal thrush to reduce the risk of infection to your partner.
Your doctor may also treat your sexual partner to prevent them from infecting you again.
Treatment may cause local burning and increased itching. These symptoms usually subside spontaneously with continued treatment. If the symptoms persist beyond 24 to 48 hours, consult your doctor.
Children
Not applicable.
Other medicines and MYCOHYDRALIN 500 mg, vaginal tablet
Do not use with spermicidal products (risk of inactivation), or with a condom or latex diaphragm (risk of condom or diaphragm breakage).
Clotrimazole may interact with the metabolism of Tacrolimus and Sirolimus. To prevent the risk of overdose of Tacrolimus or Sirolimus, inform your doctor or pharmacist before using Mycohydralin.
Tell your doctor or pharmacist if you are using, have recently used or may use any other medicines.
MYCOHYDRALIN 500 mg, vaginal tablet with food, drink and alcohol
Not applicable.
Pregnancy and lactation
MYCOHYDRALIN 500 mg, vaginal tablet may be used during pregnancy. However, as a precautionary measure, it is preferable to avoid using the product during the first trimester of pregnancy.
As a precautionary measure, the use of the applicator is not recommended during pregnancy.
It is possible that clotrimazole passes into breast milk. As a precautionary measure, breast-feeding should be discontinued for the duration of treatment.
If you are pregnant or breastfeeding, think you might be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before using clotrimazoleor pharmacist before using this medicine.
Driving and using machines
Not applicable.
3. HOW TO USE MYCOHYDRALIN 500 mg, vaginal tablet
Always use this medicine exactly as directed in this leaflet or as instructed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
Dosage
Vaginal use, DO NOT swallow.
Single administration of one tablet in the evening to be placed at the bottom of the vagina.
If symptoms persist beyond 3 days, a second vaginal tablet may be administered.
If symptoms persist beyond 7 days, consult your doctor.
Always use thismedicine exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
How to take it
- ·Use without applicator:
After thorough hand washing, insert the tablet deeply into the vagina, preferably in a lying position. The easiest way to do this is to lie on your back with your knees bent and spread apart.
- ·Use with an applicator
Use the applicator to insert the tablet into the vagina preferably at night at bedtime.
|
1- Take the applicator out of its packaging. Pull out the plunger (A) as far as it will go. Take the tablet out of the blister pack and push it 1 cm into the applicator (B) so that the rounded part of the tablet is outside the applicator
|
|
|
2- Place the applicator at the entrance to the vaginal opening and insert it deep into the vagina, preferably in a lying position. The easiest way to do this is to lie on your back with your knees bent and spread apart.
3- Hold the applicator in this position and press the plunger (A) so that the tablet is deposited in the vagina.
Gently remove the applicator.
|
|
|
4- After use, clean the applicator carefully with hot water (not boiling).
To do this, remove the stem A from the applicator B completely, past the stop.
The applicator should not be flushed down the toilet.
|
|
If you have used more MYCOHYDRALIN 500 mg, vaginal tablet than you should
No cases of overdose have been reported to date.
If you forget to use MYCOHYDRALIN 500 mg, vaginal tablet
Not applicable.
If you stop using MYCOHYDRALIN 500 mg, vaginal tablet
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, but they do not always occur in everyone.
Itching, redness, skin rash,
Vaginal irritation, burning, swelling,
Decreased blood pressure, loss of consciousness,
Choking sensation,
Vaginal bleeding, Local pain, Discomfort,
Reporting 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres
By reporting adverse reactions, you are helping to provide more information about the safety of the medicine.
5. HOW TO STORE MYCOHYDRALIN 500 mg, vaginal tablet
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box after EXP. The expiry date refers to the last day of that month.
No special storage conditions.
Do not dispose of any medicine in the sewer or in your household waste. Ask your pharmacist to dispose of any medication you no longer use. This will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What MYCOHYDRALIN 500 mg vaginal tablet contains
The active substance is :
Clotrimazole................................................................................................................... 500 mg
For one vaginal tablet.
The other components are: Lactose, maize starch, lactic acid, magnesium stearate, colloidal anhydrous silica, crospovidone, hypromellose, microcrystalline cellulose, calcium lactate.
What MYCOHYDRALIN 500 mg vaginal tablet is and what it contains
This medicine is presented as a vaginal tablet. Box of 1 tablet with applicator.
Marketing authorisation holder
BAYER HEALTHCARE SAS
220 avenue de la Recherche
59120 LOOS
Français
English
