NOTICE
ANSM - Updated: 23/10/2017
Name of the drug
GYNOPURA LP 150 mg, ovum extended release
Econazole nitrate
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is GYNOPURA LP 150 mg prolonged-release egg and when is it used?
2. What information do you need to know before using GYNOPURA LP 150 mg, prolonged-release egg?
3. How to use GYNOPURA LP 150 mg, ovum extended release?
4. What are the possible side effects?
5. How to store GYNOPURA LP 150 mg, ovum extended release?
6. Contents of the package and other information.
1. WHAT IS GYNOPURA LP 150 mg, Extended-Release Egg AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: ANTIINFECTION AND ANTISEPTICS FOR GYNECOLOGICAL USE - ATC code: G01AF05.
GYNOPURA LP is a medicine of the family of anti-infectives (treatment of infections) and antiseptics for gynecological use.
This medicine is indicated for the local treatment of mycoses (diseases caused by microscopic fungi) of the vulva and vagina, sometimes super-infected.
2. BEFORE YOU USE GYNOPURA LP 150 mg, prolonged-release egg?
Never use GYNOPURA LP:
· if you are allergic to econazole nitrate, other similar antifungal medicinal products or to any of the other ingredients of this medicine, listed in section 6.
· in combination with a diaphragm or latex condom because of the risk of rupture.
Warnings and precautions
Talk to your doctor or pharmacist about using GYNOPURA LP .
Special warnings
· Local treatment of mycosis is only part of the overall treatment. To avoid relapses, the search for factors favoring your doctor is essential.
Precautions for use
· Do not use an acidic soap for local hygiene (the acidity favoring the proliferation of fungi). See the tips in section 3.
This treatment can lead to local burns, irritation and increased itching. Generally, these phenomena give way spontaneously to the continuation of the treatment. If symptoms persist beyond 24 to 48 hours, stop treatment and consult your doctor.
Children and adolescents
Not applicable.
Other medicines and GYNOPURA LP
NEVER use GYNOPURA LP in combination with a diaphragm or latex condom because of the risk of rupture.
GYNOPURA LP is not recommended in combination with spermicidal products (products used to destroy sperm), as this may render these products inactive.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription
GYNOPURA LP with food and drinks
Not applicable.
Pregnancy and breast feeding
This medicine will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue.
Breastfeeding is possible in case of treatment with this drug but caution is required.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
GYNOPURA LP contains
Not applicable.
3. HOW TO USE GYNOPURA LP 150 mg, prolonged-release egg?
Dosage
In the majority of cases, the duration of the treatment is 3 consecutive days: to introduce deeply into the vagina 1 ovum the evening at bedtime, preferably in lying position. The easiest way to do this is to lie on your back with your knees bent and spread.
Respect the recommended duration of treatment, even if the symptoms (for example, itching and white discharge) have disappeared or if your periods begin.
If your fungus persists, a second course of 3 eggs may be necessary, either immediately after the first course of treatment or after an interval of 10 days without treatment.
IN ALL CASES, STRICTLY COMPLY WITH YOUR DOCTOR'S ORDER.
Administration mode
Vaginal way. GYNOPURA LP should not be swallowed.
Duration of the treatment
In the majority of cases, the duration of treatment is 3 consecutive days.
Practical advice :
· Wash your hands thoroughly before and after administering the product,
· Wash with neutral or alkaline pH soap
· Use your own towels (glove, towel), so as not to contaminate those around you,
· Wear cotton underwear,
· Avoid douching,
· Avoid wearing periodic tampons during treatment,
· Do not interrupt treatment during periods
· Your doctor will estimate the need:
o Also treat your sexual partner
o Prescribe an antifungal agent to apply locally.
If you use more GYNOPURA LP than you should
If you have used too much GYNOPURA LP, or if you accidentally swallowed the medicine, consult your doctor or pharmacist.
If you forget to use GYNOPURA LP
Do not take a double dose to make up for the dose you forgot to take.
If you stop using GYNOPURA LP
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (affects 1 to 10 patients in 100):
· Itching (pruritus), burning sensation in the skin.
Uncommon side effects (affects 1 to 10 patients in 1,000):
· Rash extended.
· Burning sensation in the vulva and vagina.
Rare side effects (affects 1 to 10 patients in 10,000):
· Redness of the skin (erythema).
Undesirable effects of unknown frequency (can not be estimated from the available data):
· Allergy (hypersensitivity).
· Swelling of the skin and / or mucous membranes (angioedema), urticaria, inflammation of the skin (contact dermatitis), peeling skin (peeling of the skin).
· At the application site: pain, irritation and swelling.
This treatment can lead to local burns and increased itching. Generally, these phenomena give way spontaneously to the continuation of the treatment. If symptoms persist beyond 24 to 48 hours, stop treatment and consult your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE GYNOPURA LP 150 mg, prolonged-release egg?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
Store at a temperature not exceeding + 30 ° C.
Do not throw drugs at the sewer. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What GYNOPURA LP contains
· The active substance is:
Econazole nitrate .............................................. .................................................. ........ 150 mg
For an extended-release egg.
· The other ingredients are: galactomannan, anhydrous colloidal silica, solid semisynthetic glycerides, stearyl heptanoate.
What GYNOPURA LP looks like and contents of the pack
Marketing Authorization Holder
BESINS INTERNATIONAL LABORATORIES
3 RUE DU BOURG THE ABBE
75003 PARIS
Operator of the marketing authorization
BESINS INTERNATIONAL LABORATORIES
13 PERIER STREET
92120 MONTROUGE
Maker
UNITHER INDUSTRIES
ZI THE MALCOURLET
03800 GANNAT
or
BESINS INTERNATIONAL LABORATORIES
13 PERIER STREET
92120 MONTROUGE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
October 2017.
Other
Detailed information on this medicine is available on the ANSM website (France).