Ginoxin Uno

Leaflet attached to the packaging: information for the patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Gynoxin Uno (LOMEXIN 600 mg)

600 mg, vaginal capsule, soft
Fenticonazole nitrate
Gynoxin Uno and LOMEXIN 600 mg are different trade names for the same medicine.

The patient 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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days 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. Package contents 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
Mucosal candidiasis of the genital organs (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 this medicine.
The vaginal capsule of Gynoxin Uno is intended for vaginal use only.

It should not be taken orally.

Only a doctor can make a reliable diagnosis of fungal infection and determine the susceptibility of the microorganism to fenticonazole. The patient should read the information in section 2 of the leaflet 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 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 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 vaginal infections in the last 6 months,
• the patient or their 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, bloody discharge, vulvar or vaginal ulcers, blisters, lower abdominal pain, back pain, or pain during urination, side effects such as redness, itching, or rash, which are related to treatment.

If the partner is also infected, 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 may damage mechanical contraceptives made of latex (condoms, vaginal diaphragms) (see "Warnings and precautions").
Concurrent 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 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 does not affect the ability to drive or use machines.

Gynoxin Uno contains

• -ethyl 4-hydroxybenzoate sodium and propyl 4-hydroxybenzoate 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, the doctor or pharmacist should be consulted.
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 more than the recommended dose of Gynoxin Uno

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

Stopping the use of Gynoxin Uno

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

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, may 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 this leaflet, the doctor, pharmacist, or nurse should be informed. 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
Phone: +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.
This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The medicine should not be stored at temperatures above 30°C.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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), ethyl 4-hydroxybenzoate sodium (E 215), propyl 4-hydroxybenzoate sodium (E 217).

What Gynoxin Uno looks like and what the package contains

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

Marketing authorization holder in France, the country of export:

EFFIK, 9-11 rue Jeanne Braconnier, 92366 Meudon la Forêt, France

Manufacturer:

EFFIK, 9-11 rue Jeanne Braconnier, 92366 Meudon la Forêt, France
Catalent Italy, S.P.A., Via Nettunense, Km 20, 100, 04011 Aprilia (LT), Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in France, the country of export: 34009 337 834 8 8

Parallel import authorization number: 305/22

Date of leaflet approval:17.08.2022
[Information about the trademark]