Ginoxin Uno

Leaflet attached to the packaging: information for the patient

Warning! Keep the leaflet! 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
recorded in Polish and Bulgarian.

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 recommendations.

• You should keep this leaflet, so that you can read it again if necessary.
• If advice or additional information is needed, 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. 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 effects on Gram-positive and Gram-negative bacteria.
Indications for use
Fungal infections of the mucous membranes of the genital organs (vulvitis and vaginitis, 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 it.
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 a fungal infection and determine the susceptibility of the microorganism to fenticonazole. You should read the information in section 2 of the leaflet, in which situations to discuss with your 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, it is recommended to use alternative contraceptive methods,
• the patient uses spermicides, vaginal douches, or other vaginal products (see "Gynoxin Uno and other drugs"), allergic 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 antifungal vaginal drugs,
• the patient is over 60 years old,
• the patient experiences any of the following symptoms:
• abnormal or irregular bleeding,
• bleeding discharge,
• lesions and blisters of the vagina and vulva,
• 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, it is recommended to treat them at the same time.

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 it 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, suspects that they may be pregnant, or plans to have a child, they should consult a doctor before using this drug. 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:

• 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 recommendations. In case of doubt, you should consult a doctor or pharmacist.
Gynoxin Uno vaginal capsules are intended for vaginal use only.
Do not take the vaginal capsules 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 adolescentsThe 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 any further doubts related to the use of this drug, you should consult a doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug 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 you experience any side effects, including any 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 gather more information 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 packaging. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
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. 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 vaseline, soy lecithin. Shell: gelatin, glycerol, titanium dioxide (E 171), ethyl 4-hydroxybenzoate (E 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.
To obtain more detailed information, you 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export: 20040138

Parallel import authorization number: 178/22 Date of approval of the leaflet: 21.04.2022

[Information about the trademark]