Ginoxin Uno

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Gynoxin Uno(Lomexin)

600 mg, vaginal capsule, soft

Fenticonazole nitrate
Gynoxin Uno and Lomexin are different trade names for the same drug.

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 as directed by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• 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 yeasts. Fenticonazole also has antibacterial activity against Gram-positive and Gram-negative bacteria.
Indications for use
Vaginal yeast infections (vulvovaginitis, vaginitis, leukorrhea).
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 yeast infection and determination of the susceptibility of the microorganism to fenticonazole can only be made by a doctor. You should read the information in section 2 of the leaflet, in which situations to talk to a doctor before using the medicine.

2. Important information before using Gynoxin Uno

When not to use Gynoxin Uno:

• Gynoxin Uno contains soybean 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 contraceptive devices made of latex are used concurrently (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,
• 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, vulvar and vaginal ulcers, including ulcers and blisters, lower abdominal pain, back pain, or pain when urinating, adverse reactions such as redness, itching, or rash, which are related to treatment.

In the case of infection of the partner, their concurrent 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 cause damage to mechanical contraceptive devices made of latex (condoms, vaginal diaphragms) (see "Warnings and precautions").
Concurrent use with spermicides is not recommended (substances used vaginally, which immobilize sperm and are used as contraception alone or together, e.g., with a diaphragm). Any local vaginal treatment may 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 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 influence on the ability to drive and use machines.

Gynoxin Uno contains:

• ethyl parahydroxybenzoate sodium and propyl parahydroxybenzoate sodium, 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 as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
The vaginal capsules of Gynoxin Uno are intended for vaginal use only. They 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, you should immediately contact a doctor or go to the nearest hospital.

Stopping the use of Gynoxin Uno

In case of further doubts related to the use of this medicine, you should consult a 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 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).
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 you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your 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
By reporting side effects, you can help provide more information on the safety of this 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.
Store at a temperature below 30°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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: light liquid paraffin, white petrolatum, soybean lecithin, gelatin, glycerol, titanium dioxide (E 171), ethyl parahydroxybenzoate sodium, propyl parahydroxybenzoate sodium.

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, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Recordati S.P.A.
Via M. Civitali 1
20148 Milan (MI)
Italy

Manufacturer:

Catalent Italy S.p.A
Via Nettunense Km 2
100, 04011 Aprilia (LT)
Italy

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export: 7594/2015/01
Parallel import authorization number: 289/23

Date of leaflet approval: 18.12.2023

[Information about the trademark]