Gino-pevaril 50

Package Leaflet: Information for the Patient

Gyno-Pevaryl 50, Vaginal Tablets

Econazole Nitrate

Read the Package Leaflet Carefully Before Using the Medication, 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 medication has been prescribed for your use only. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

Gyno-Pevaryl 50, in the form of vaginal tablets, contains the active substance econazole nitrate. Econazole belongs to a group of antifungal medications and has an effect on: dermatophytes, yeasts, and mold fungi. It also has an effect on Gram-positive bacteria. Gyno-Pevaryl 50 is used in women with fungal infections of the vulva and vagina.

2. Important information before using Gyno-Pevaryl 50

When not to use Gyno-Pevaryl 50

• If you are allergic to the active substance or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Before starting to use Gyno-Pevaryl 50, discuss it with your doctor. Gyno-Pevaryl 50 is intended for vaginal use only. Do not take it orally. When using Gyno-Pevaryl 50 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 50 at the same time as a diaphragm or latex condom. You should discuss the use of other contraceptive methods with your doctor during treatment. Do not use Gyno-Pevaryl 50 vaginal tablets together with any other local (external or vaginal) treatment for the genital area. 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 medication.

Children and adolescents

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

Gyno-Pevaryl 50 and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. The effectiveness of spermicides may be significantly reduced by the use of vaginal medications, including Gyno-Pevaryl 50. Avoid contact between Gyno-Pevaryl 50 and latex products, such as latex diaphragms or condoms, as the components of the vaginal tablets may damage latex. Due to the minimal absorption of the active substance into the body after vaginal administration, it is unlikely to interact significantly with other medications. However, interactions between econazole nitrate and oral anticoagulants (blood thinners) have been reported. If you are taking oral anticoagulants, such as warfarin or acenocoumarol, tell your doctor, who will monitor their anticoagulant effect.

Using Gyno-Pevaryl 50 in elderly patients

Data on the use of the medication in women over 65 years of age are insufficient.

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 medication. The active substance of Gyno-Pevaryl 50 is absorbed from the vagina, so the medication should not be used in the first trimester of pregnancy, unless your doctor considers it essential for your health. Gyno-Pevaryl 50 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 50 during breastfeeding, caution should be exercised.

Driving and using machines

The effect of the medication on the ability to drive and use machines is not known.

3. How to use Gyno-Pevaryl 50

Always use Gyno-Pevaryl 50 exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Do not take Gyno-Pevaryl 50 orally. Insert the tablet deep into the vagina, preferably in a half-lying position. Use one tablet once daily, before going to bed, for at least 14 consecutive days. Continue treatment even if symptoms (itching, discharge) disappear before the end of the 14 days. If you are pregnant, wash your hands thoroughly before inserting the tablet.

Using more than the recommended dose of Gyno-Pevaryl 50

Gyno-Pevaryl 50 is for vaginal use only. In case of accidental oral ingestion of the tablet, treat symptomatically. If the medication accidentally gets into your eyes, rinse them with clean water or a physiological saline solution, and if symptoms persist, consult your doctor. If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Gyno-Pevaryl 50 can cause side effects, although not everybody gets them. The most common side effects observed in clinical trials were reactions at the site of application, 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 site of application. If you experience any of these side effects, stop using the medication and contact your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Pharmacovigilance 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

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 medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gyno-Pevaryl 50 contains

• The active substance is: econazole nitrate. One vaginal tablet contains 50.0 mg of econazole nitrate.
• The other ingredients are: solid fat: type A and type B.

What Gyno-Pevaryl 50 looks like and contents of the pack

15 vaginal tablets, individually packaged 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: