Gino-pevaril 150

Package Leaflet: Information for the Patient

Gyno-Pevaryl 150, vaginal capsules
Econazole nitrate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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. Contents of the pack and other information

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

Gyno-Pevaryl 150 vaginal capsules contain the active substance econazole nitrate. Econazole belongs to a group of antifungal medicines and has an effect on: dermatophytes, yeasts, and mold fungi. It also has an effect 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 you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Gyno-Pevaryl 150, discuss it with your doctor.
Gyno-Pevaryl 150 is intended for vaginal use only. Do not take it orally.
When using Gyno-Pevaryl 150 and latex contraceptives (latex condoms or diaphragms) at the same time, the effectiveness of these contraceptives may be reduced.
Therefore, it is not recommended to use Gyno-Pevaryl 150 at the same time as a diaphragm or latex condom. You should discuss the use of other contraceptive methods during treatment with your doctor.
Gyno-Pevaryl 150 vaginal capsules should not be used together with any other local (external or vaginal) treatment for genital organs.
If severe irritation or allergic symptoms occur, treatment should be discontinued and you should consult your doctor again.
If you are allergic to imidazole derivatives, you 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 in this age group have not been established.

Gyno-Pevaryl 150 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
The effectiveness of spermicidal contraceptives may be significantly reduced by the use of 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 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 (reduced blood clotting). If you are taking oral anticoagulants, such as warfarin or acenocoumarol, tell your doctor, who will monitor their anticoagulant effect.

Using Gyno-Pevaryl 150 in elderly patients

There is limited experience with the use of Gyno-Pevaryl 150 in women over 65 years of age.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice 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 your doctor considers it essential for your 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 are unsure, consult your doctor or pharmacist.
Do not take Gyno-Pevaryl 150 orally.
A capsule should be inserted deep into the vagina, preferably in a half-lying position. The medicine is used once a day, before bedtime, for 3 consecutive days. If the disease recurs or a positive culture result is obtained one week after the end of treatment, the treatment should be repeated.
If you are pregnant, wash your hands thoroughly before using the capsule.

Using more than the recommended dose of Gyno-Pevaryl 150

Gyno-Pevaryl 150 is for vaginal use only. In case of accidental oral ingestion of a capsule, symptomatic treatment should be used. If the medicine accidentally gets into the eyes, rinse them with clean water or physiological saline solution, and if the symptoms persist, consult your doctor.
If you have any further questions about using the medicine, ask 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 local reactions, 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 peeling, and pain, irritation, and swelling at the application site.
If you experience any of these side effects, stop using the medicine and contact your doctor immediately.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Gyno-Pevaryl 150

Keep out of 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 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 pack and other information

What Gyno-Pevaryl 150 contains

• The active substance is econazole nitrate. One capsule contains 150.0 mg of econazole nitrate.
• The other ingredients are solid fats: type A and type B.

What Gyno-Pevaryl 150 looks like and contents of the pack

3 capsules, packaged individually in foil, in a cardboard box.

Marketing authorization holder

Karo Pharma AB
Box 16184
103 24, Stockholm
Sweden
medinfo@karopharma.com

Manufacturer

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.
Estrada Consiglieri Pedroso, 69-B
Queluz de Baixo
2730-055 Barcarena
Portugal

Date of revision of the leaflet: