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GYNOPURA LP econazole 150MG mycosis 2 Vaginal Ovules

Local treatment of vulvar and vaginal mycosis.

Description of GYNOPURA LP Econazole 150MG Mycosis 2 Vaginal Ovules

Gynopura LP Econazole 150 mg Mycosis 2 Vaginal Ova is a medicine containing econazole nitrate : antifungal and antibacterial .

It is indicated in the local treatment of fungus infections (diseases due to microscopic fungi) of the vulva and vagina sometimes super-infected.

Advice for use and dosage

In the majority of cases : 1 egg at bedtime in single administration to be introduced deep into the vagina, preferably lying down.

In the case of recurrent or rebellious mycosis implying favoring factors : an egg at bedtime and an egg the next morning.

Comment on advice for use and dosage of GYNOPURA LP econazole 150MG mycose 2 Vaginal Ovules with our partner Avis checked after your purchase.

Composition

The active substance is :
Econazole nitrate: 150 mg for 1 egg.

The other ingredients are : Galactomannan, anhydrous colloidal silica, solid semisynthetic glycerides, stearyl heptanoate.

Precaution of use

Do not use Gynopura Ge LP 150 mg in the following cases:

allergy to any component of the product (see composition) or a related substance (belonging to the imidazole group);
use with a latex diaphragm.

Presentation of GYNOPURA LP econazole 150MG mycosis

Gynopura comes in the form of a booth containing 2 eggs.

Our advice and expert advice in pharmacy

Symptoms of vaginal yeast infection include itching, irritation or vaginal burns and irritation at the entrance of the vagina . The vulva is often inflamed and has a glossy red appearance and shiny. Pain is felt during urination and sexual intercourse. Finally, there are white and thick vaginal discharge. The manifestations mentioned (pain, burns ...) can also be caused by an allergy or genital herpes. It is advisable to consult your doctor to make sure of the diagnosis.

Vaginal mycosis: How to avoid it ?

To prevent a vaginal mycosis from developing, certain simple gestures and reflexes can suffice. It is especially important to be gentle. Good reflexes:

Adopt regular but not excessive personal hygiene (one shower each day, never more than two).
To do this, also use a mild cleanser specially formulated for this fragile area or a soap with a mild alkaline pH, ie which respects the pH of the vulva area. In general, it varies between 4 and 5.5.
You can also make this toilet with clear water, simply.

Notice

Pharmacovigilance Report an adverse drug reaction(s)

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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).

Vidal file

VIDAL OF THE FAMILY

GYNOPURA ovum

Local antifungal

This medicine is a generic of GYNO-PEVARYL LP 150 mg

. Presentations . Composition . Indications . Contraindications . Attention . Drug interactions . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon

PRESENTATIONS ^(summary)

GYNOPURA Ge LP 150 mg: ovum extended release ; box of 1.
Refunded at 30%. - price: 2,11 euro (s).

GYNOPURA Ge LP 150 mg: ovum extended release ; box of 2.
Not refunded - Free price -

Besins International Laboratory

COMPOSITION ^(summary)

	p ovule LP
Econazole nitrate	150mg

INDICATIONS ^(summary)

This gynecological egg contains an antifungal of the imidazole family.
It is used in the local treatment of mycosis of the vagina and vulva, including candidiasis .

CONTRAINDICATIONS ^(summary)

This medicine should not be used if you are allergic to imidazoles .

ATTENTION ^(summary)

Do not use a latex diaphragm as a method of contraception during treatment: risk of diaphragm rupture by latex spoilage.
If the infection does not go away after a few days, consult your doctor.

DRUG INTERACTIONS ^(summary)

Like any vaginal treatment, this medication may decrease the contraceptive effectiveness of creams and spermicidal eggs.

PREGNANCY and BREASTFEEDING ^(summary)

Pregnancy :
No adverse effects to the unborn child have been established with this medication. It can be prescribed during pregnancy

Breastfeeding:
The possibility of an effect of the drug in the infant is very unlikely. It can be used in women who are breastfeeding.

DIRECTIONS AND DOSAGE ^(summary)

The egg should be introduced deep into the vagina, preferably at bedtime.

Usual dosage:

A single shot of 1 egg; in some cases, this treatment can be renewed the next morning. This egg has a specific composition that allows it to remain active for several days after its introduction (prolonged release of the active ingredient).

TIPS ^(summary)

Introduce the egg in a supine position and then lie down for 5 to 10 minutes. By melting in the vagina, the egg can cause an annoying flow: it is advisable to wear a protection.
During menstruation, do not interrupt treatment and avoid wearing tampons.
In the case of recurrent gynecological mycoses ( candidiasis ), it is useful to follow the usual advice to prevent the abnormal development of candida albicans and other microscopic fungi:

to limit the use of antibiotics to conditions which absolutely require their use. Indeed, the 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, favor cotton panties that absorb better perspiration, do not keep his swimsuit after swimming in pool, avoid wearing clothes too tight;
change often the internal or external protections during the rules;
avoid the use of acid soaps: they favor the multiplication of mushrooms.

Your partner may be contaminated with no symptoms . A medical consultation is needed to discuss the benefit of a treatment.

ADVERSE POSSIBLE EFFECTS ^(summary)

Aggravation of burns and itching at the beginning of treatment: these symptoms translate the destruction of the microscopic fungi which release an irritating substance. These events do not usually happen again in later applications. If not, it may be an intolerance or an allergy to the drug: contact your doctor.

LEXICON ^(summary)

allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication or ingestion of a 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
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 fungal cultures: penicillium (penicillin), streptomyces (streptomycin). They are currently manufactured by chemical synthesis. Antibiotics are divided into families: penicillins, cephalosporins, macrolides, tetracyclines (cyclins), sulfonamides, aminoglycosides, lincosanides, phenicolates, polymyxins, quinolones, imidazoles, etc.
Inappropriate use of antibiotics can promote resistance: use an antibiotic only on prescription, respect its dosage and duration, do not give and do not advise another person an antibiotic that you have been prescribed .

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

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

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

imidazole
Family of drugs that includes antifungals, antibiotics and antiparasitics.

sustained release
A method of manufacturing a medicament, which allows a slow and gradual release of the active substances in the body.
Abbreviation: LP.

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

symptom
Disorder 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 patients.

Pharmacist's advice

used for :

vaginal mycosis