Gino-pevaril 150

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Gyno-Pevaryl 150 (Pevaryl)

150 mg, vaginal capsules

Econazole nitrate
Gyno-Pevaryl 150 and Pevaryl are different trade names for the same medicine.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Gyno-Pevaryl 150 and what is it used for
• 2. Important information before using Gyno-Pevaryl 150
• 3. How to use Gyno-Pevaryl 150
• 4. Possible side effects
• 5. How to store Gyno-Pevaryl 150
• 6. Contents of the pack and other information

1. What is Gyno-Pevaryl 150 and what is it used for

Gyno-Pevaryl 150, in the form of vaginal capsules, contains the active substance econazole nitrate. Econazole belongs to a group of antifungal medicines and has an effect on dermatophytes, yeast, and mold fungi. It also has an effect on Gram-positive bacteria.
Gyno-Pevaryl 150 is used in women with fungal infections of the vulva and vagina.

2. Important information before using Gyno-Pevaryl 150

When not to use Gyno-Pevaryl 150

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Gyno-Pevaryl 150, discuss it with your doctor.
Gyno-Pevaryl 150 is intended exclusively for vaginal use. It should not be taken orally.
When using Gyno-Pevaryl 150 and contraceptive devices made of rubber (latex condoms or vaginal diaphragms) at the same time, the effectiveness of these devices may be reduced. Therefore, it is not recommended to use Gyno-Pevaryl 150 at the same time as a vaginal diaphragm or latex condom. You should discuss the use of other contraceptive methods with your doctor during treatment with Gyno-Pevaryl 150.
The vaginal capsule of Gyno-Pevaryl 150 should not be used together with another local (external or vaginal) treatment for genital organs.
If severe symptoms of irritation or allergy occur, treatment should be discontinued and the doctor consulted again.
If the patient is allergic to imidazole derivatives, they may also be allergic to econazole nitrate, the active substance of the medicine.

• the active substance of the medicine.

Children and adolescents

Gyno-Pevaryl 150 should not be used in patients under 16 years of age, as the safety and efficacy of the medicine in this age group have not been established.

Gyno-Pevaryl 150 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
The effectiveness of spermicides may be significantly reduced by the use of vaginal medicines, including Gyno-Pevaryl 150.
Do not let Gyno-Pevaryl 150 come into contact with latex products, such as latex diaphragms or condoms, as the ingredients of the vaginal capsule may damage the latex.
Due to the low absorption of the active substance into the body after vaginal administration, it is unlikely to interact significantly with other medicines. However, interactions between econazole nitrate and oral anticoagulants (blood thinners) have been reported. If you are taking oral anticoagulants, such as warfarin or acenocoumarol, tell your doctor, who will monitor their anticoagulant effect.

Using Gyno-Pevaryl 150 in elderly patients

There is limited experience with the use of Gyno-Pevaryl 150 in women over 65 years of age.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
The active substance of Gyno-Pevaryl 150 is absorbed from the vagina, so the medicine should not be used during the first trimester of pregnancy, unless the doctor considers it essential for the patient's health. Gyno-Pevaryl 150 may be used during the second or third trimester of pregnancy if the expected benefits to the mother outweigh the potential risk to the fetus.
When using Gyno-Pevaryl 150 during breastfeeding, caution is advised.

Driving and using machines

The effect of the medicine on the ability to drive and use machines is not known.

3. How to use Gyno-Pevaryl 150

Always use Gyno-Pevaryl 150 exactly as your doctor has told you.
If you are not sure, consult your doctor or pharmacist.
Do not take Gyno-Pevaryl 150 orally.
Insert the capsule deeply into the vagina, preferably in a half-lying position. The medicine is used once a day, before bedtime, for 3 consecutive days. If the disease recurs or a positive culture result is obtained one week after the end of treatment, the treatment should be repeated.
If you are pregnant, wash your hands thoroughly before using the capsule.

Using more than the recommended dose of Gyno-Pevaryl 150

Gyno-Pevaryl 150 is for vaginal use only. If a capsule is accidentally swallowed, symptomatic treatment should be used. If the medicine accidentally gets into the eyes, they should be rinsed with clean water or a physiological saline solution, and if the symptoms do not disappear, consult a doctor.
If you have any further doubts about using the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gyno-Pevaryl 150 can cause side effects, although not everybody gets them.
The most common side effects observed in clinical trials were reactions at the site of application, such as a burning sensation of the skin, vulva, and vagina, itching, and rash.
Rarely (less than 1 in 1000 patients), redness occurred, and very rarely (less than 1 in 10,000 patients), hypersensitivity reactions, sudden swelling of the face or throat (angioedema), hives, contact dermatitis, skin peeling, pain, irritation, and swelling at the site of application.
If such side effects occur, stop using the medicine and contact your doctor immediately.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Gyno-Pevaryl 150

Keep out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Gyno-Pevaryl 150 contains

• The active substance is econazole nitrate. One vaginal capsule contains 150 mg of econazole nitrate.
• The other ingredients are solid fat.

What Gyno-Pevaryl 150 looks like and contents of the pack

3 vaginal capsules, packaged individually in foil, in a cardboard box.
For further information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden

Manufacturer:

Lusomedicamenta Sociedade Técnica Farmacêutica, S.A.
Estrada Consiglieri Pedroso
69-B Queluz de Baixo
2730-055 Barcarena
Portugal

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Greece, the country of export: 11364/14.4.94
54054/09/3.2.2010
40432/19.09.2008
80901/18/15.05.2019

Parallel import authorization number: 118/14

Date of revision of the leaflet: 04.03.2024

[Information about the trademark]