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

The contents of the leaflet should be carefully read 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 so that it can be re-read if necessary.
• If advice or additional information is needed, a 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. 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 activity against Gram-positive and Gram-negative bacteria.
Indications for use
Mucosal candidiasis of the genital organs (vulvovaginitis, vaginitis, leucorrhoea).
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 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 information in section 2 of the leaflet should be read to determine in which situations 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 soybean 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 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 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, adverse reactions 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 can cause damage to 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 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 medicine. Gynoxin Uno should be used under medical supervision during pregnancy and breastfeeding.

Driving and using machines

Gynoxin Uno has no effect on the ability to drive or use machines.

Gynoxin Uno contains

• ethyl parahydroxybenzoate sodium and propyl parahydroxybenzoate 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, a 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 ingestion of a vaginal capsule, a doctor or the nearest hospital should be contacted immediately.

Stopping the use of Gynoxin Uno

In case of further doubts about the use of this medicine, a 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, 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 any side effects occur, including any side effects not listed in the 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
Tel.: + 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.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
The medicine should not be stored at temperatures above 30°C.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. 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: liquid paraffin, white petrolatum, soybean lecithin, gelatin, glycerol, titanium dioxide (E 171), ethyl parahydroxybenzoate sodium (E 215), propyl parahydroxybenzoate sodium (E 217).

What Gynoxin Uno looks like and what the packaging 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 Spain, the country of export:

Casen Recordati, S.L.
Autovía de Logroño, Km. 13,300
50180 Utebo (Saragossa)
Spain

Manufacturer:

Recordati Industria Chimica e Farmaceutica, S.P.A.
Via Matteo Civitali 1
I-20148 Milan
Italy
Catalent Italy, S.P.A., Via Nettunense, Km 20,100, Aprilia (LT) 04011, 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
Spanish export license number: 667907.4

Parallel import license number: 239/12

Date of leaflet approval:21.04.2022
[Information about the trademark]