Gyno-pevaryl 150
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Please keep the leaflet. Information on the immediate packaging is in a foreign language.
Gyno-Pevaryl 150 (Gyno-Pevaryl 150 mg)
150 mg, globules
Econazole nitrate
Gyno-Pevaryl 150 and Gyno-Pevaryl 150 mg are different trade names of the same medicinal product written in Polish and Bulgarian languages.
Please read the following information carefully before using this medicine, as it contains important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any doubts, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What Gyno-Pevaryl 150 is and what it is 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 preparation in the form of globules containing the active substance econazole nitrate. Econazole belongs to the group of antifungal medicines and is effective 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, please consult your doctor.
Gyno-Pevaryl 150 is intended for vaginal use only. It must not be taken by mouth.
When Gyno-Pevaryl 150 is used at the same time as 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. Please discuss with your doctor the use of alternative contraceptive methods during treatment.
Gyno-Pevaryl 150 vaginal 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 the doctor 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
Gyno-Pevaryl 150 should not be used 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
Inform your doctor or pharmacist about any other medicines you are currently using, have recently used, or plan to use.
The spermicidal effect of contraceptive products may be considerably weakened 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 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 this 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 in a semi-reclining position.
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 applying 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 accidentally 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 everybody gets 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 with the medicine 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 a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 reactions enables the collection of further information on the safety of the medicine.
5. How to store Gyno-Pevaryl 150
Keep out of sight and reach of children.
Store 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 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. 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 globule contains 150 mg of econazole nitrate.
- Other ingredients are: hard fat.
What Gyno-Pevaryl 150 looks like and contents of the pack
3 globules individually packed in foil, in a cardboard box.
For additional information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
Manufacturer:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Bulgaria, country of export: 20020515
Parallel Import Licence number: 188/23