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Gyno-Pevaryl 150 mg, 3 Vaginal Suppositories
Over-the-counter medication

Gyno-Pevaryl 150 mg, 3 Vaginal Suppositories

Gyno Pevaryl 150 mg, 3 suppositories, available at your online organic pharmacy. This medication is indicated for the topical treatment of yeast infections (conditions caused by microscopic fungi) of the vulva and vagina, which may sometimes be complicated by a secondary bacterial infection.

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Gyno Pevaryl 150 mg, box of 3 vaginal suppositories

For warnings, precautions, and contraindications, please refer to the package insert.

Genital candidiasis, more commonly known as a genital yeast infection, most often affects women. What causes it? Specific circumstances such as menstruation, pregnancy, or taking antibiotics. A genital yeast infection causes redness and itching. Treatment is usually topical.

This is a fungal infection of the genital organs. It is extremely common, particularly among women. The fungus responsible is almost always Candida albicans. The infection most often occurs endogenously, linked to the growth of Candida already present in the vagina or on the skin. It can also occur exogenously, through sexual contact, swimming pools, beaches, and so on. However, vaginal candidiasis is not considered a sexually transmitted infection.

Description of Gyno-Pevaryl 150 mg Vaginal Suppositories

Gyno Pevaryl 150 mg, 3 Vaginal Suppositories is a medication in the class of anti-infectives (for treating infections) and antiseptics for gynecological use.

Gyno-Pevaryl 150 mg, 3 Vaginal Suppositories is indicated for thelocal treatment of yeast infections(conditions caused by microscopic fungi) of thevulva and vagina, which may sometimesbe complicated by a secondary bacterial infection.

Symptoms of Vaginal Yeast Infections
Once the infection has set in, the symptoms are unmistakable:

  • Constant itching of the vulva and vaginal opening
  • Thick, creamy white discharge
  • A burning sensation in the vagina during urination
  • Sexual intercourse that becomes increasingly painful
  • Bright red, swollen vulva.
  • All of these discomforts can make your life miserable.

Directions for Use of GynoPevaryl 150 mg Vaginal Suppositories

In most cases, the treatment lasts for 3 consecutive days 

  • Insert 1 suppository deeply into the vagina at bedtime, preferably while lying down.
  • The easiest way to do this is to lie on your back with your knees bent and spread apart.

Follow the recommended treatment duration even if symptoms (such as itching and white discharge) have disappeared or if your period begins.
If your yeast infection persists, a second course of 3 suppositories may be necessary, either immediately after the first course or after a 10-day treatment-free interval.

As a maintenance treatment, we recommendJailys Soothing Balmfor all women who want to protect their intimate area from external irritants, who are seeking comprehensive restoration and long-lasting relief, and who want softer, more beautiful skin and mucous membranes, as well as a healthy scent.

For vaginal use only. GYNO-PEVARYLmust not be swallowed.

  • Wash your hands thoroughly before and after applying the product,   
  • Wash with a pH-neutral or alkaline soap,
  • Use your own personal hygiene items (washcloth, towel) to avoid contaminating those around you,
  • Wear cotton clothing,
  • Avoid douching,
  • Avoid using tampons during treatment,
  • Do not interrupt treatment during your period,
  • Your doctor will determine whether it is necessary:
    • Whether your sexual partner should also be treated
    • To prescribe a topical antifungal medication for you.

There are many possible causes of a vaginal yeast infection. For example, a disruption in the vaginal flora can lead to a yeast infection. This could be due to taking antibiotics that eliminate the bacteria needed to fight infections, or excessive hygiene that weakens the immune system. Vaginal yeast infections can also affect women who are stressed or tired.

Moisture increases the risk of vaginal infections, which explains why vaginal inflammation or irritation following unlubricated sexual intercourse can worsen and develop into a yeast infection. Wearing tight underwear made of materials other than cotton—which effectively absorbs moisture—is therefore not recommended, as it can promote yeast infections.

Hormonal imbalances affect the vagina’s immune defenses, so a woman’s estrogen levels can also contribute to a vaginal yeast infection. Fungi feed on sugar, so it stands to reason that excessive consumption of foods high in sugar can lead to a vaginal yeast infection.

Composition of Gyno Pevaryl Vaginal Suppositories

Econazole nitrate 150 mg

Per vaginal suppository.
Other ingredients include: Solid semi-synthetic glycerides.

Packaging of Gyno-Pevaryl

Box of 3 vaginal suppositories

We recommend a natural preventive treatment with the dietary supplementLactibiane CND 10M from Pileje, which helps restore vaginal and intestinal flora in cases of intimate discomfort (vaginal yeast infections).

For the maintenance phase, we recommend the Pileje Lactibiane CND 5M dietary supplement.

As a complementary treatment and in the event of a recurrence, our naturopathic pharmacists recommendPhysioflor Microbiotiqueto prevent vaginal yeast infections by restoring and maintaining a balanced vaginal flora.

Medication Warnings

Please note: Medications are not like other products. Read the medication label carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.

  • Please inform your online pharmacist of any current treatments to identify potential interactions. The order confirmation form includes a custom message field for this purpose.
  • Click here to view the package insert for this medication on the website of the French National Agency for Medicines and Health Products Safety (ANSM).

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated on: 20/07/2017

Name of the medicinal product

GYNO-PEVARYL 150 mg, ovule

Econazole Nitrate

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 talk to your doctor if you do not feel better or feel less well.

What is in this leaflet?

1. What is GYNO-PEVARYL 150 mg, ovule and in which cases is it used?

2. What should I know before using GYNO-PEVARYL 150 mg, egg ?

3. How to use GYNO-PEVARYL 150 mg, ovule ?

4. What are the possible side effects?

5. How to store GYNO-PEVARYL 150 mg, ovule ?

6. Package contents and other information .

1. WHAT GYNO-PEVARYL 150 Mg, Ovum AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: ANTI-INFECTIOUS AND ANTISEPTIC FOR GYNECOLOGICAL USE - ATC code: G01AF05.

GYNO-PEVARYL 150 mg, ovule is an anti-infectious drug (treatment of infections) and antiseptics for gynecological use.

This medicine is indicated for the treatment of fungal infections in the
microscopic mushrooms) of the vulva and vagina sometimes overinfected.

2. BEFORE YOU USE GYNO-PEVARYL 150 mg, ovule?

Do not use GYNO-PEVARYL 150 mg, egg:

· if you are allergic to miconazole nitrate, other similar antifungal medications or any of the other ingredients of this medication mentioned in section 6.

· in combination with a latex diaphragm or condom due to the risk of rupture.

Warnings and Precautions

Talk to your doctor or pharmacist before using GYNO-PEVARYL.

GYNO-PEVARYL should only be administered to the vagina. This medication should not be swallowed.

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 acid soap for local hygiene (acidity promoting fungal growth). See practical tips in section 3.

This treatment may cause local burning, irritation and increased itching. Generally, these phenomena yield spontaneously to the continuation of the treatment. If symptoms persist beyond 24 to 48 hours, discontinue treatment and see your doctor.

Children and Youth

Not applicable.

Other drugs and GYNO-PEVARYL 150 mg, ovule

NEVER use GYNO-PEVARYL in combination with a diaphragm or latex condom, because of the risk of rupture.

GYNO-PEVARYL is not recommended in combination with spermicidal products (products used to destroy spermatozoa), as this may render these products inactive.

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including medicines obtained without a prescription.

GYNO-PEVARYL 150 mg, egg with food and beverages

Not applicable.

Pregnancy and breast feeding

This medication will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.

Breast-feeding is possible with this medication but caution is advised.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Not applicable.

GYNO-PEVARYL 150 mg, ovule contains

Not applicable.

3. HOW TO USE GYNO-PEVARYL 150 mg, ovule?

Dosage

In the majority of cases, the duration of the treatment is 3 consecutive days : to insert deeply into the vagina 1 ovule in the evening at bedtime, preferably in lengthened position. The easiest way to do this is to lie down on your back with your knees folded away.

Respect the recommended treatment time, even if the symptoms (eg, itching and white discharge) have disappeared or if your period begins.

If your fungus persists, a second cure of 3 eggs may be necessary, either immediately after the first cure or after an interval without treatment for 10 days.

IN ALL CASES, DO NOT COMPLY WITH YOUR DOCTOR'S ORDER.

Administration mode

Vaginal pathway. GYNO-PEVARYL 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 administration of the product,

· Wash with a soap at neutral or alkaline pH,

· Use your own towels (gloves, towels), so as not to contaminate your surroundings,

· Wear cotton underwear,

· Avoid vaginal douches,

· Avoid wearing periodic pads during treatment,

· Do not interrupt treatment during menstruation,

· Your doctor will estimate the need:

o Also treat your sexual partner

o To prescribe an antifungal to apply locally.

If you used more GYNO-PEVARYL 150 mg, ovule than you should have

If you have used too much GYNO-PEVARYL, or if you have accidentally swallowed the drug, consult your doctor or pharmacist.

If you forget to use GYNO-PEVARYL 150 mg, ovule

Do not take a double dose to make up for a missed dose.

If you stop using GYNO-PEVARYL 150 mg, ovule

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.

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 per 1,000):

· Extended rash (rash).

· Burning sensation in the vulva and the vagina.

Rare side effects (affects 1 to 10 of 10,000 patients):

· 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 cause 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, discontinue treatment and see your doctor.

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 GYNO-PEVARYL 150 mg, ovule?

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 .

Store at temperatures not above 30 ° C.

Do not throw any medication into sewer. 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 GYNO-PEVARYL 150 mg contains, ovule

· The active substance is:

Econazole Nitrate .............................................. .................................................. 150 mg

For an egg

· The other components are: solid hemi-synthetic glycerides.

What is GYNO-PEVARYL 150 mg, ovule and contents of the pack

This medication is in the form of an ovule. Box of 3 ova.

Marketing Authorization Holder

JANSSEN-CILAG

1, RUE CAMILLE DESMOULINS

TSA 91003

92787 ISSY LES MOULINEAUX CEDEX 9

Marketing Authorization Operator

JANSSEN-CILAG

1, RUE CAMILLE DESMOULINS

TSA 91003

92787 ISSY LES MOULINEAUX CEDEX 9

Maker

JANSSEN PHARMACEUTICA NV

TURNHOUTSEWEG, 30

2340 BEERSE

Belgium

or

LUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA SA

ESTRADA CONSIGLIERI PEDROSO, 69-B

QUELUZ OF BAIXO

2730-055 BARCARENA

PORTUGAL

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:

{month YYYY}.

Other

Detailed information on this medicine is available on the ANSM website (France).

VIDAL OF THE FAMILY

Gyno-Pevaryl

antifungal

econazole

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

PRESENTATIONS (summary)

GYNO-PEVARYL 150 mg: egg; box of 3.
Refunded at 30%. - price: 3,59 euro (s).

GYNO-PEVARYL LP 150 mg: prolonged-release egg; box unit.
Refunded at 30%. - price: 1.95 euro (s).

Janssen-Cilag Laboratory

COMPOSITION (summary)
p ovule p ovule LP
Econazole nitrate 150 mg 150 mg

INDICATIONS (summary)
This gynecological ovule contains an antifungal agent of the imidazole family.
It is used in the local treatment of fungal infections of the vagina and the vulva, especially candidiasis .
CONTRAINDICATIONS (summary)
This medication should not be used if you are allergic to imidazole .
WARNING (Contents)
If the infection does not go away after a few days, consult your doctor.
DRUG INTERACTIONS (summary)
The use of a latex diaphragm is contraindicated during treatment: risk of rupture of the diaphragm by alteration of the latex.
Like any vaginal treatment, this drug may also decrease the contraceptive effectiveness of spermicidal creams and ovules.
PREGNANCY AND BREAST-FEEDING (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 infants is highly unlikely. It can be used in breastfeeding women.
DIRECTIONS FOR USE AND DOSAGE (summary)
The egg should be inserted deep into the vagina, preferably in the evening at bedtime.

Usual dosage:

GYNO-PEVARYL 150 mg : 1 egg per day, for 3 days.
This treatment can be extended for another 3 days or be renewed 10 days later.
GYNO-PEVARYL LP 150 mg : single dose of 1 egg; in some cases, this treatment may be renewed the following morning. This ovule has a specific composition which allows it to remain active several days after its introduction (prolonged release of the active principle).
TIPS (summary)
Introduce the egg into the lying position and then lie down for 5 to 10 minutes. By melting in the vagina, the ovum can be at the origin of a disturbing flow: it is advisable to wear a protection.
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.
POSSIBLE ADVERSE EFFECTS (summary)
Aggravation of burns and itching at the beginning of treatment: these symptoms reflect the destruction of microscopic fungi that release an irritating substance. These manifestations do not usually recur in subsequent applications. If this is not the case, it may be an intolerance or an allergy to the medication: contact your doctor.


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.


sustained release
A process for the manufacture of a medicament which enables a slow and gradual release of the active substances into the body.
Abbreviation: LP.


MST
Abbreviation for sexually transmitted disease.
Today also known as STI (Sexually Transmitted Infections) to include symptom-free infections, at least initially (HIV, for example).


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


malaria
Tropical disease caused by a parasite (Plasmodium) transmitted by a mosquito (female anopheline). It results in fever returning at regular intervals, chills and other very different symptoms. Any high fever occurring within a month of returning from a trip to a tropical country should lead to suspected malaria.
Synonym: malaria.


symptom
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.

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