Gyno-pevaryl 150

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Gyno-Pevaryl 150 (Pevaryl)
150 mg globules
Econazole nitrate
Gyno-Pevaryl 150 and Pevaryl are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Gyno-Pevaryl 150 is a vaginal preparation in the form of globules containing the active substance
econazole nitrate. Econazole belongs to the group of antifungal medicines and is active against:
dermatophytes, yeasts, and mould fungi. It is also active against Gram-positive bacteria.
Gyno-Pevaryl 150 is used in women for 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Gyno-Pevaryl 150, discuss this with your doctor.
Gyno-Pevaryl 150 is intended for vaginal use only. It must not be taken orally.
When Gyno-Pevaryl 150 is used simultaneously with rubber-based contraceptives (latex condoms or vaginal diaphragms), their effectiveness may be reduced. Therefore, the use of Gyno-Pevaryl 150 together with a vaginal diaphragm or latex condom is not recommended. Discuss with your doctor the use of alternative contraceptive methods during treatment with this medicine.
Gyno-Pevaryl 150 should not be used together with other local (external or vaginal) treatments for the genital organs.
If severe irritation or allergic symptoms occur, treatment should be discontinued and medical advice should be sought again.
If the patient is allergic to imidazole derivatives, she may also be allergic to econazole nitrate – the active substance of the medicine.

Children and adolescents
Do not use this medicine in patients under 16 years of age, as safety and efficacy of the medicine have not been established in this age group.
Gyno-Pevaryl 150 and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
The effectiveness of spermicidal contraceptives may be considerably 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 ingredients of the globules may damage latex.
Due to the low systemic absorption of the active substance following vaginal administration, significant interactions with other medicines are unlikely. However, interactions between econazole nitrate and oral anticoagulants (blood-thinning medicines) have been reported (resulting in reduced blood clotting). If the patient is taking oral anticoagulants such as warfarin or acenocoumarol, she should inform her doctor, who will need to monitor the anticoagulant effect.
Use of Gyno-Pevaryl 150 in elderly patients
Data on the use of the medicine in women over 65 years of age are insufficient.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The active substance of Gyno-Pevaryl 150 is absorbed from the vagina; therefore, 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 benefit to the mother outweighs the potential risk to the fetus.
Caution should be exercised when using Gyno-Pevaryl 150 during breastfeeding.
Driving and operating machinery
The effect of the medicine on the ability to drive and operate machinery is unknown.

3. How to use Gyno-Pevaryl 150

Gyno-Pevaryl 150 should always be used as directed by the physician.
If in doubt, consult your doctor or pharmacist.
Do not take Gyno-Pevaryl 150 orally.
The ovule should be inserted deeply into the vagina, preferably while lying down.
The treatment should be applied once daily, before bedtime, for 3 consecutive days. In case of recurrence
of infection or a positive culture result one week after completion of treatment, the course should be repeated.
If the patient is pregnant, she should thoroughly wash her hands before inserting the ovule.
Use of a higher than recommended dose of Gyno-Pevaryl 150
Gyno-Pevaryl 150 is intended for topical use only. In case of accidental oral ingestion of the ovule,
symptomatic treatment should be administered. If the product gets into the eyes, rinse them thoroughly with clean water or physiological saline solution; if symptoms persist, seek medical advice.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most commonly observed adverse reactions in clinical trials were reactions at the site of administration, such as burning sensation of the skin, vulva and vagina, itching and rash.
Flushing occurred rarely (less than 1 in 1,000 patients), and very rarely (less than 1 in 10,000 patients) hypersensitivity reactions, sudden swelling of the face or throat (angioedema), urticaria, contact dermatitis, skin desquamation, as well as pain, irritation and swelling at the site of administration.
If any of these adverse reactions occur, treatment should be discontinued and medical advice should be sought immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide 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.
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 stated month.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Gyno-Pevaryl 150 contains

• The active substance is: econazole nitrate. Each vaginal globule contains 150.0 mg of econazole nitrate.
• Other components: hard fat.

What Gyno-Pevaryl 150 looks like and contents of the pack
Blister pack containing 3 vaginal globules in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Greece, the country of export: 80901/18/15.05.2019
Parallel import authorisation number: 202/23