Gino-pevaril 150

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Gyno-Pevaryl 150 (Гино-Певарил 150 mg)

150 mg, vaginal capsules

Econazole nitrate
Gyno-Pevaryl 150 and Гино-Певарил 150 mg are different trade names for the same medicine, written in Polish and Bulgarian.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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. Package contents 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 the group of antifungal medicines and has an effect on: dermatophytes, yeast, and mold fungi. It also acts 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, you should discuss it with your doctor. Gyno-Pevaryl 150 is intended solely for vaginal use. It should not be taken orally. During simultaneous use of Gyno-Pevaryl 150 and latex contraceptives (latex condoms or vaginal diaphragms), the effectiveness of these contraceptives 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. The vaginal capsule of Gyno-Pevaryl 150 should not be used together with another local (external or vaginal) treatment for the genital organs. If severe symptoms of irritation or allergy occur, treatment should be discontinued and you should consult your doctor again. If the patient is allergic to imidazole derivatives, they may also be allergic to econazole nitrate, 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. The effectiveness of spermicidal contraceptives may be significantly reduced by the use of vaginal medicines, including Gyno-Pevaryl 150. You should avoid contact between Gyno-Pevaryl 150 and latex products, such as latex diaphragms or condoms, as the ingredients of the vaginal capsules may damage 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, you should tell your doctor, who will monitor their anticoagulant effect.

Using Gyno-Pevaryl 150 in elderly patients

There is insufficient data on 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 plan to have a child, you should consult your doctor or pharmacist before using this medicine. The active substance of Gyno-Pevaryl 150 is absorbed from the vagina, so the medicine should not be used in the first trimester of pregnancy, unless your doctor considers it essential for your health. Gyno-Pevaryl 150 may be used in 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 should be exercised.

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

Gyno-Pevaryl 150 should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult your doctor or pharmacist. Gyno-Pevaryl 150 should not be taken orally. The vaginal capsule should be inserted deep into the vagina, preferably while lying down. The medicine is used once a day, before bedtime, for 3 consecutive days. If the disease recurs or a positive culture result is obtained a week after the end of treatment, the treatment should be repeated. If you are pregnant, you should wash your hands thoroughly before using the vaginal capsule.

Using a higher dose of Gyno-Pevaryl 150 than recommended

Gyno-Pevaryl 150 is for vaginal use only. In case of accidental oral ingestion of the vaginal capsule, 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, you should consult your doctor. In case of any further doubts about the use of the medicine, you should 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, and pain, irritation, and swelling at the site of application. If such side effects occur, you should stop using the medicine and immediately consult your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, 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 gather more information on the safety of the medicine.

5. How to store Gyno-Pevaryl 150

Keep out of sight and reach of children. Store at a temperature below 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 specified month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Gyno-Pevaryl 150 contains

• The active substance is: econazole nitrate. 1 vaginal capsule contains 150 mg of econazole nitrate.
• The other ingredients are: solid fat.

What Gyno-Pevaryl 150 looks like and what the package contains

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

Marketing authorization holder in Bulgaria, the country of export:

Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden

Manufacturer:

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

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
Authorization number in Bulgaria, the country of export: 20020515

Parallel import authorization number: 188/23

Date of leaflet approval: 06.09.2023

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