Ginoxin Uno

Leaflet attached to the packaging: information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

GYNOXINUNO (Lomexin 600 mg)
600 mg, vaginal capsule, soft
Fenticonazole nitrate
Gynoxin Uno and Ломексин 600 mg are different trade names for the same drug written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• You should keep this leaflet so that you can read it again if necessary.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

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 packaging 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 yeast. Fenticonazole also has antibacterial effects on Gram-positive and Gram-negative bacteria.
Indications for use
Vaginal yeast infections (vulvitis, vaginitis, leukorrhea).
Treatment of mixed vaginal infections.
Gynoxin Uno is intended for use in adults and adolescents over 16 years of age.
Patients over 60 years of age should consult their 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 microorganism's sensitivity to fenticonazole can only be made by a doctor. You should read the information in section 2 of the leaflet to find out in which situations you should talk to your 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 soy lecithin. If the patient is allergic to peanuts or soy, they 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 infections in the last 6 months,
• the patient or their partner has had a sexually transmitted disease in the past,
• if 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, bloody discharge, vaginal and vulvar lesions, including ulcers and blisters, lower abdominal pain, back pain, or pain when urinating, side effects such as redness, itching, or rash, which are related to treatment.

In the case of infection of the partner, their 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 latex mechanical contraceptives (condoms, vaginal diaphragms) (see "Warnings and precautions").
It is not recommended to use spermicides at the same time (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 they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. Gynoxin Uno should be used during pregnancy and breastfeeding under medical supervision.

Driving and using machines

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

Gynoxin Uno contains:

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

3. How to use Gynoxin Uno

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.
The vaginal capsules of Gynoxin Uno are intended for vaginal use only. The vaginal 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 a higher dose of Gynoxin Uno than recommended

In case of swallowing a vaginal capsule, the patient should immediately contact their doctor or go to the nearest hospital.

Stopping the use of Gynoxin Uno

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gynoxin Uno 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 recommended, 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).
After using this medicine, the following side effects have been observed:
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 patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Reporting side effects can help 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.
Do not use this medicine after the expiry date stated on the packaging. 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Gynoxin Uno contains

• The active substance of Gynoxin Uno is fenticonazole. 1 vaginal capsule, soft, contains 600 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: liquid paraffin, white petrolatum, soy lecithin, gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217).

What Gynoxin Uno looks like and what the pack contains

1 vaginal capsule, soft, in a PVC/PVDC/Aluminum blister pack, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Recordati Ireland Ltd.
Raheens East, Ringaskiddy Co. Cork, Ireland

Manufacturer:

Catalent Italy S.p.A.
Via Nettunense Km 20
100-04011 Aprilia (LT)
Italy

Parallel importer:

Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czeski Cieszyn
Czech Republic

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export:20040138

Parallel import authorization number: 193/22 Date of approval of the leaflet: 5.05.2022

[Information about the trademark]