Ginoxin Uno

Package Leaflet: Information for the Patient

Gynoxin Uno, 600 mg, Vaginal Capsule, Soft

Fenticonazole Nitrate

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

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 7 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet

• 1. What is Gynoxin Uno and what is it used for
• 2. Important information before using Gynoxin Uno
• 3. How to use Gynoxin Uno
• 4. Possible side effects
• 5. How to store Gynoxin Uno
• 6. Contents of the pack and other information

1. What is Gynoxin Uno and what is it used for

Gynoxin Uno contains the active substance fenticonazole, which is an imidazole derivative with a broad spectrum of antifungal activity, including against yeasts. Fenticonazole also has antibacterial activity against Gram-positive and Gram-negative bacteria.
Indications for use
Fungal infections of the genital mucous membranes (vulvovaginitis, vaginitis, discharge).
Treatment of mixed vaginal infections.
Gynoxin Uno is intended for use in adults and adolescents over 16 years of age.
Patient over 60 years of age should consult a doctor before using the medicine.
The vaginal capsule of Gynoxin Uno is intended for vaginal use only.

It should not be taken orally.

A reliable diagnosis of fungal infection and determination of the susceptibility of the microorganism to fenticonazole can only be made by a doctor. The information in section 2 of the leaflet should be read to determine when to consult a doctor before using the medicine.

2. Important information before using Gynoxin Uno

When not to use Gynoxin Uno:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• Gynoxin Uno contains soybean lecithin. If the patient is allergic to peanuts or soy, she should not use this medicine.

Warnings and precautions

The use of Gynoxin Uno should be discussed with a doctor or pharmacist if:

• the patient is pregnant or breastfeeding (see "Pregnancy, breastfeeding, and fertility"),
• mechanical contraceptives made of latex are used at the same time (see "Gynoxin Uno and other medicines"). During the use of this medicine, alternative contraceptive methods are recommended,
• the patient uses spermicides, vaginal douches, or other vaginal products (see "Gynoxin Uno and other medicines"),
• hypersensitivity reactions to the medicine occur,
• symptoms do not decrease within 7 days or worsen,
• the partner is also infected,
• the patient has had more than two vaginal infections in the last 6 months,
• the patient or her partner has had a sexually transmitted disease,
• the patient is allergic to imidazole or other vaginal antifungal medicines,
• the patient is over 60 years old,
• the patient experiences any of the following symptoms: abnormal or irregular bleeding, blood-stained discharge, vulvar or vaginal ulcers, including blisters, lower abdominal pain, back pain, or pain during urination, adverse reactions such as redness, itching, or rash, which are related to treatment.

In the case of infection of the partner, simultaneous treatment is recommended.

Children and adolescents

Gynoxin Uno is not intended for use in children and adolescents under 16 years of age.

Gynoxin Uno and other medicines

Gynoxin Uno contains fats and oils that can damage mechanical contraceptives made of latex (condoms, vaginal diaphragms) (see "Warnings and precautions").
Concomitant use with spermicides is not recommended (substances used vaginally that immobilize sperm and are used as contraception alone or together, e.g., with a diaphragm). Any local vaginal treatment can inactivate locally used spermicides.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine. Gynoxin Uno should be used under medical supervision during pregnancy and breastfeeding.

Driving and using machines

Gynoxin Uno has no effect on the ability to drive and use machines.

Gynoxin Uno contains:

• - ethyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate sodium, which may cause allergic reactions (possible late reactions).

3. How to use Gynoxin Uno

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.
The vaginal capsules of Gynoxin Uno are intended for vaginal use only.
The capsules should not be taken orally.
The recommended dose is:

• 1 vaginal capsule, soft, used once. Insert deeply into the vagina in the evening before bedtime. If symptoms persist, the next dose can be repeated after 3 days.

Children and adolescents
The recommended dose for adolescents over 16 years of age is the same as for adults.

Using more than the recommended dose of Gynoxin Uno

In case of ingestion of a vaginal capsule, a doctor or the nearest hospital should be contacted immediately.

Stopping the use of Gynoxin Uno

In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After inserting the capsule into the vagina, a mild, transient burning sensation may occur.
If Gynoxin Uno is used as directed, the active substance is poorly absorbed, and the occurrence of systemic side effects is unlikely.
Locally used medicines, especially when used for a long time, can cause hypersensitivity (see "Warnings and precautions" in section 2).
The following side effects have been observed after using this medicine:
Very rare(less than 1 in 10,000):

• burning sensation of the vulva and vagina,
• redness,
• itching,
• rash.

Unknown(frequency cannot be estimated from the available data):

• hypersensitivity at the application site.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 Gynoxin Uno

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Gynoxin Uno contains

• The active substance of the medicine is fenticonazole. 1 vaginal capsule, soft, contains 600 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: liquid paraffin, white vaseline, soybean lecithin, gelatin, glycerol, titanium dioxide (E 171), ethyl 4-hydroxybenzoate (E 215), propyl 4-hydroxybenzoate sodium (E 217).

What Gynoxin Uno looks like and contents of the pack

1 vaginal capsule, soft, in a PVC/PVDC/Aluminum blister, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Recordati Industria Chimica e Farmaceutica S.p.A.
Via Civitali 1
20148 Milan
Italy

Manufacturer

Catalent Italy S.p.A.
Via Nettunense km 20, 100
04011 Aprilia (LT)
Italy

Date of last revision of the leaflet:

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
http://urpl.gov.pl/