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).