Gyno-pevaryl 150
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Warning! Keep the 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 future reference.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What is Gyno-Pevaryl 150 and what is it used for
- Important information before using Gyno-Pevaryl 150
- How to use Gyno-Pevaryl 150
- Possible side effects
- How to store Gyno-Pevaryl 150
- 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 globule formulation 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 indicated 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, please consult 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 contraceptive rings), the effectiveness of these contraceptives may be reduced. Therefore, concomitant use of Gyno-Pevaryl 150 with a vaginal contraceptive ring or latex condoms is not recommended. Please discuss with your doctor the use of alternative contraceptive methods during treatment with this medicine.
Gyno-Pevaryl 150 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 doctor should be consulted 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 150 and other medicines
Tell your doctor or pharmacist about any other medicines you are currently using, have recently used, or plan to use.
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 (medicines that reduce blood clotting) have been reported. 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 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 considered essential by the doctor 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 exactly as directed by the physician.
In case of 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 medicine
should be used once daily, before bedtime, for 3 consecutive days. In case of recurrence of the
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 medicine gets into the eyes by accident,
they should be rinsed thoroughly with clean water or physiological saline solution; if symptoms persist,
medical advice should be sought.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The most commonly observed adverse effects in clinical trials were reactions at the site of administration, such as burning sensation of the skin, vulva and vagina, itching and rash.
Erythema occurred rarely (less than 1 in 1,000 patients), and 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 occurred very rarely (less than 1 in 10,000 patients).
If any of these adverse effects occur, treatment with the medicine should be discontinued and immediate contact with a doctor should be made.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Effects of Medicinal Products, 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
Reporting adverse effects allows the collection of additional information on the safety of medicine use.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.
- The other component is: hard fat.
What Gyno-Pevaryl 150 looks like and contents of the pack
Blister pack containing 3 vaginal globules in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 Farmacêutica, 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 in:
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 authorisation number in Greece, the country of export: 80901/18/15.05.2019
Parallel import licence number: 64/22