Gino-pevaril 150

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is 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.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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 or pharmacist. 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 packaging 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, you should discuss it with your doctor.
Gyno-Pevaryl 150 is intended solely 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 Gyno-Pevaryl 150 capsule 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 contraceptive devices 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 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 anticoagulant medicines (blood thinners) have been reported. If you are taking oral anticoagulant medicines, 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 are planning to have a baby, 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 during the first trimester of pregnancy, unless your doctor considers it essential for your 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 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.
If you have any doubts, you should consult your doctor or pharmacist.
Do not use Gyno-Pevaryl 150 orally.
The 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 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 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 a doctor.
If you have any further doubts about using 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 contact your doctor immediately.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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 provide more information on the safety of the medicine.

5. How to store Gyno-Pevaryl 150

Keep out of the 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.
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. Contents of the packaging and other information

What Gyno-Pevaryl 150 contains

• The active substance is: econazole nitrate.

1 capsule contains 150.0 mg of econazole nitrate.

• The other ingredients are: solid fat.

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

A blister pack containing 3 vaginal capsules in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Janssen-Cilag Pharmaceuticals A.E.B.E.
Leof. Eirinis 56
151 21 Pefki, Athens
Greece

Manufacturer:

Lusomedicamenta Sociedade Técnica Pharmacêutica, SA
Estrada Consiglieri Pedroso
69-B Queluz de Baixo
2730-055 Barcarena
Portugal

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Greece, the country of export: 80901/18/15.05.2019
Parallel import authorization number: 64/22
Date of leaflet approval: 02.02.2022
[Information about the trademark]