GYNO-PEVARYL 50

Package leaflet: Information for the patient

Gyno-Pevaryl 50, globules
Econazole nitrate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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 50 is and what it is used for
2. Important information before using Gyno-Pevaryl 50
3. How to use Gyno-Pevaryl 50
4. Possible side effects
5. How to store Gyno-Pevaryl 50
6. Contents of the pack and other information

1. What Gyno-Pevaryl 50 is and what it is used for

Gyno-Pevaryl 50 is a vaginal preparation in the form of globules containing the active substance econazole nitrate. Econazole belongs to the group of antifungal agents and is active against dermatophytes, yeasts, and mould fungi. It is also effective against Gram-positive bacteria.
Gyno-Pevaryl 50 is indicated in women for fungal infections of the vulva and vagina.

2. Important information before using Gyno-Pevaryl 50

When not to use Gyno-Pevaryl 50

• 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 50, consult your doctor.
Gyno-Pevaryl 50 is intended for vaginal use only. It must not be taken orally.
When used simultaneously with rubber-based contraceptives (latex condoms or vaginal diaphragms), the effectiveness of these contraceptive methods may be reduced.
Therefore, the use of Gyno-Pevaryl 50 together with a vaginal diaphragm or latex condom is not recommended. Discuss with your doctor the use of alternative contraceptive methods during treatment.
Gyno-Pevaryl 50 globules 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 the patient should consult a doctor again.
If the patient is allergic to imidazole derivatives, she may also be allergic to econazole nitrate – the active substance of this medicine.

Children and adolescents
Do not use this medicine in patients under 16 years of age, as the safety and efficacy of the medicine have not been established in this age group.

Gyno-Pevaryl 50 and other medicines
Inform 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 significantly reduced by locally applied vaginal medicines, including Gyno-Pevaryl 50.
Avoid contact between Gyno-Pevaryl 50 and latex products such as latex diaphragms or condoms, as the ingredients of the globules may damage latex.
Due to minimal 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 thinners) 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 monitor the anticoagulant effect.

Use of Gyno-Pevaryl 50 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 50 is absorbed from the vagina; therefore, the medicine should not be used during the first trimester of pregnancy unless considered essential by the doctor for the patient's health.
Gyno-Pevaryl 50 may be used during the second or third trimester of pregnancy if the expected benefits to the mother outweigh the potential risks to the fetus.
Caution should be exercised when using Gyno-Pevaryl 50 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 50

Gyno-Pevaryl 50 should always be used as directed by the physician.
In case of doubts, consult a doctor or pharmacist.
Do not take Gyno-Pevaryl 50 orally.
The ovule should be inserted deeply into the vagina, preferably while lying down. The medicine should be used once daily, before bedtime, for at least 14 consecutive days.
Treatment should be continued even if symptoms (such as itching, discharge) have subsided before the end of 14 days.
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 50
Gyno-Pevaryl 50 is intended for topical use only. In case of accidental oral ingestion of the ovule, symptomatic treatment should be administered. If the medicine gets into the eyes, rinse them thoroughly with clean water or physiological saline solution; if symptoms persist, seek medical advice.
In case of any further doubts regarding the use of the medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
The most commonly observed adverse reactions in clinical trials were reactions at the application site,
such as burning sensation of the skin, vulva and vagina, itching and rash.
Erythema 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 application site.
If any of these adverse reactions occur, treatment should be discontinued and a doctor should be contacted
immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor,
pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Gyno-Pevaryl 50

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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What the medicine contains Gyno-Pevaryl 50

• The active substance is: econazole nitrate. Each globule contains 50.0 mg of econazole nitrate.
• Other components are: hard fat: type A and type B.

What Gyno-Pevaryl 50 looks like and contents of the pack
15 globules individually packed in foil, packed in a cardboard box.
Marketing Authorisation Holder
Karo Pharma AB
Box 16184
103 24, Stockholm
Sweden
[email protected]
Manufacturer
Lusomedicamenta - Sociedade
Técnica Farmacêutica, S.A
Estrada Consiglieri Pedroso, 69-B
Queluz de Baixo
2730-055 Barcarena
Portugal