Ginoxin Uno

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, 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 drug.

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

This drug 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 inform their doctor or pharmacist. 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
Fungal infections of the mucous membranes of the genital organs (vulvovaginitis, vaginitis, discharge).
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 drug.
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 sensitivity of the microorganism to fenticonazole can only be made by a doctor. You should read the information in section 2 of the leaflet, which describes the situations in which you should consult a doctor before using the drug.

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 drug (listed in section 6).
• Gynoxin Uno contains soybean lecithin. If the patient is allergic to peanuts or soy, they should not use this drug.

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 drugs"). During the use of this drug, alternative contraceptive methods are recommended,
• the patient uses spermicides, vaginal douches, or other vaginal products (see "Gynoxin Uno and other drugs"),
• hypersensitivity reactions to the drug 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 drugs,
• 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 during urination, 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 drugs

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 (substances used vaginally that immobilize sperm and are used as contraception alone or together, e.g., with a diaphragm) at the same time. Any local vaginal treatment can inactivate locally applied spermicidal contraceptives.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Gynoxin Uno does not affect the ability to drive or use machines.

Gynoxin Uno contains:

• ethyl 4-hydroxybenzoate sodium propyl 4-hydroxybenzoate sodium (E 217)which may cause allergic reactions (possible late-type reactions).

3. How to use Gynoxin Uno

This drug 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 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 sleep. 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 drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, 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 applied drugs, especially when used for a long time, can cause hypersensitivity (see "Warnings and precautions" in section 2).
After using this drug, 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 inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be collected on the safety of the drug.

5. How to store Gynoxin Uno

The drug should be stored out of sight and reach of children.
Do not use this drug after the expiry date stated on the carton and blister pack 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. The patient should ask their pharmacist 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 nitrate. 1 vaginal capsule, soft, contains 600 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: liquid paraffin, light liquid paraffin, soybean lecithin, gelatin, glycerol, titanium dioxide (E 171), ethyl 4-hydroxybenzoate sodium, propyl 4-hydroxybenzoate sodium (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 France, the country of export:

Effik
Bâtiment "Le Newton"
9-11 rue Jeanne Braconnier
92366 Meudon La Forêt
France

Manufacturer:

Effik
Bâtiment "Le Newton"
9-11 rue Jeanne Braconnier
92366 Meudon La Forêt
France

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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in France, the country of export: 34009 337 834 8 8
337 834-8
Parallel import authorization number: 234/23

Date of leaflet approval: 16.10.2023

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