Ginoxin Uno

Leaflet attached to the packaging: information for the patient

Note: Keep the leaflet, information on the immediate packaging in a foreign language.

GYNOXIN UNO (LOMEXIN) 600 mg, vaginal capsule, soft
Fenticonazole nitrate
GYNOXIN UNO LOMEXINare 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 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 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 yeast. Fenticonazole also has antibacterial effects on 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.
Patients over 60 years of age should consult their doctor before using this medicine.
The vaginal capsule of Gynoxin Uno is intended for vaginal use only.

Do not take it orally.

Only a doctor can reliably diagnose 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 you should talk to your doctor before using the medicine.

2. Important information before using Gynoxin Uno

When not to use Gynoxin Uno:

• Gynoxin Uno contains soybean lecithin. If you are allergic to peanuts or soy, you should not use this medicine.

Warnings and precautions

You should discuss the use of Gynoxin Uno with your doctor or pharmacist if:

• you are pregnant or breastfeeding (see "Pregnancy, breastfeeding, and fertility"),
• you are using mechanical contraceptives made of latex (see "Gynoxin Uno and other medicines"). During the use of this medicine, it is recommended to use alternative contraceptive methods,
• you are using spermicides, vaginal douches, or other vaginal products (see "Gynoxin Uno and other medicines"),
• you experience hypersensitivity reactions to the medicine,
• symptoms do not decrease within 7 days or worsen,
• your partner is also infected,
• you have had more than two infections in the last 6 months,
• you or your partner have had a sexually transmitted disease,
• you are allergic to imidazole or other vaginal antifungal medicines,
• you are over 60 years old,
• you experience any of the following symptoms:
• abnormal or irregular bleeding,
• blood-stained discharge,
• ulcers and blisters on the vulva and vagina,
• lower abdominal pain, back pain, or pain when urinating,
• adverse reactions such as redness, itching, or rash, which are related to treatment.

If your partner is also infected, it is recommended that they be treated 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 medicines

Gynoxin Uno contains fats and oils that can damage latex contraceptives (condoms, 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 with a diaphragm) at the same time. Any local vaginal treatment can inactivate locally used spermicides

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
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 parahydroxybenzoate and propyl parahydroxybenzoate sodium, which may

cause allergic reactions (possible late reactions).

3. How to use Gynoxin Uno

This medicine 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.
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 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 any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

• 4. Possible side effects

Like all medicines, this medicine 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 used medicines, especially when used for a long time, can cause allergies (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 side effects not listed in the 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, 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 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 carton and blister pack. 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. 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: gelatin, glycerol, titanium dioxide (E 171), ethyl parahydroxybenzoate sodium (E 215), propyl parahydroxybenzoate sodium (E 217), liquid paraffin, white petrolatum, soybean lecithin.

What Gynoxin Uno looks like and what the pack contains

1 vaginal capsule, soft, in a PVC/Al blister pack, in a carton box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

CASEN RECORDATI, S.L., Autovia de Logroño, Km. 13,300, 50180 Utebo (Saragossa), Spain

Manufacturer:

CATALENT ITALY, S.P.A., Via Nettunense, Km 20,100, Aprilia (LT) 04011, Italy

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Damco Poland Sp. z o.o., ul. Postępu 18, 02-676 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Natur Produkt Zdrovit Sp. z o.o., ul. Nocznickiego 31, 01-918 Warsaw
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Spanish authorization number, country of export:667907.4
Parallel import authorization number:223/13
Date of leaflet approval: 06.07.2022
[Information about the trademark]