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 (Ломексин 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.

The patient 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.

• The leaflet should be kept so that it can be read again if necessary.
• 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 yeast. Fenticonazole also has antibacterial activity against Gram-positive and Gram-negative bacteria.
Indications for use
Mucosal candidiasis 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.
Patient over 60 years of age should consult a doctor before using the drug.
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 candidiasis 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 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 soy 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,
• 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 when urinating, side effects such as redness, itching, or rash, which are related to treatment.

If the partner is also infected, 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 contraceptives (condoms, diaphragms) (see "Warnings and precautions").
It is not recommended to use Gynoxin Uno at the same time as spermicides (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, or thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this drug. 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 (E 215) and propyl 4-hydroxybenzoate (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. In case of doubt, the doctor or pharmacist should be consulted.
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 a higher dose of Gynoxin Uno than recommended

In case of swallowing 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 drug, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all drugs, Gynoxin Uno can cause side effects, although not everyone will experience 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 drugs, especially when used for a long time, can cause allergies (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 determined from 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 patient should inform their doctor, pharmacist, or nurse. 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
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.
The drug should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
The drug should not be stored at a temperature above 30°C.
Drugs should not be disposed of in the sewage system or household waste containers. The pharmacist should be asked how to dispose of unused drugs. 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: light liquid paraffin, white petrolatum, soy lecithin. Shell: gelatin, glycerol, titanium dioxide (E 171), ethyl 4-hydroxybenzoate (E 215), propyl 4-hydroxybenzoate (E 217).
• 215), propyl 4-hydroxybenzoate (E 217).

What Gynoxin Uno looks like and what the package 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 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:

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 Bulgaria, the country of export: 20040138

Parallel import authorization number: 189/23

Date of leaflet approval:06.09.2023
[Information about the trademark]