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

150 mg, vaginal capsules

Econazole nitrate

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 inform 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. 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, yeasts, 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, 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 latex contraceptives (latex condoms or vaginal diaphragms) at the same time, the effectiveness of these contraceptives may decrease. 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. Gyno-Pevaryl 150 should not be used together with another local (external or vaginal) treatment for genital organs. If severe irritation or allergic symptoms 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 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 locally applied vaginal medicines, including Gyno-Pevaryl 150. Avoid contact between Gyno-Pevaryl 150 and latex products, such as latex diaphragms or condoms, as the components of the 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 the patient is taking oral anticoagulants, such as warfarin or acenocoumarol, they should inform their doctor, who will monitor their anticoagulant activity.

Using Gyno-Pevaryl 150 in elderly patients

There is insufficient data on the use of the medicine in women over 65 years of age.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 the doctor considers it essential for the patient's 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 as directed by your doctor. If you have any doubts, 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 the patient is pregnant, they should wash their 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 applied. 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 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 exfoliation, and pain, irritation, and swelling at the site of application. If such side effects occur, the use of the medicine should be discontinued and the doctor consulted immediately.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform 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 gather more information on the safety of the medicine.

5. How to store Gyno-Pevaryl 150

Keep the medicine out of the sight and reach of children. Store in 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. 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 of the medicine is econazole nitrate. One capsule contains 150 mg of econazole nitrate.
• The other ingredients are semi-synthetic solid glycerides.

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

3 capsules packaged individually in PVC/PE blisters, in a cardboard box. For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

Karo Pharma AB
Box 16184
103 24 Stockholm, Sweden

Manufacturer:

JANSSEN PHARMACEUTICA NV
Turnhoutseweg, 30, 2340 Beerse, Belgium
LUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA S.A.
Estrada consiglieri pedroso, 69-b
Queluz de baixo, 2730-055 Barcarena, Portugal

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Authorization number in France, the country of export:34009 320 227 62
320 227 6
Parallel import authorization number:550/12
Date of leaflet approval: 29.06.2022
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