Package leaflet: Information for the patient

Warning: Keep the leaflet, 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 medicinal product.
Please read the leaflet carefully 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 instructions of a doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, contact your doctor.

Contents of the leaflet

What Gynoxin Uno is and what it is used for
Important information before using Gynoxin Uno
How to use Gynoxin Uno
Possible side effects
How to store Gynoxin Uno
Contents of the package and other information

1. What Gynoxin Uno is and what it is used for

Gynoxin Uno contains the active substance fenticonazole, an imidazole derivative with broad-spectrum antifungal activity, including against yeasts. Fenticonazole also has antibacterial activity against Gram-positive and Gram-negative bacteria.
Indications
Fungal infections of the genital mucous membranes (vulvovaginal candidiasis, vaginitis, vaginal discharge).
Treatment of mixed vaginal infections.
Gynoxin Uno is intended for use in adults and adolescents above the age of 16.
Patients over 60 years of age should consult a doctor before use.
The Gynoxin Uno vaginal capsule is intended for vaginal use only.
Do not take orally.
Only a doctor can reliably diagnose fungal infection and determine microbial sensitivity to fenticonazole. Please refer to section 2 of this leaflet for information on situations in which you should speak with your doctor before using this medicine.

2. Important information before using Gynoxin Uno

When not to use Gynoxin Uno:

if the patient is allergic to the active substance or to 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, she 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 contraceptive methods made of latex are used simultaneously (see "Gynoxin Uno and other medicines"). During treatment with this medicine, alternative contraceptive methods are recommended,
spermicides, vaginal irrigations or other vaginal products are being used (see "Gynoxin Uno and other medicines"),
hypersensitivity reactions to the medicine occur,
symptoms do not improve within 7 days or worsen,
the partner is also infected,
the patient has had more than two infections in the past 6 months,
the patient or her partner has ever had a sexually transmitted infection,
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 vaginal discharge,
- lesions of the vagina and vulva, including ulcers and blisters,
- pain in the lower abdomen, back or pain during urination,
- adverse reactions such as redness, itching or rash associated with 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 medicines
Gynoxin Uno contains fats and oils which may damage mechanical contraceptive methods made of latex (e.g. condoms, vaginal diaphragms) (see "Warnings and precautions").
Simultaneous use with spermicides (vaginal agents that immobilize sperm and are used as contraception alone or together with, for example, a diaphragm) is not recommended. Any local vaginal treatment may inactivate locally applied spermicidal contraceptives.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Gynoxin Uno should be used during pregnancy and breastfeeding only under medical supervision.
Driving and operating machinery
Gynoxin Uno has no influence on the ability to drive or operate machinery.
Gynoxin Uno contains:

sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may

cause allergic reactions (delayed-type reactions possible).

3. How to use Gynoxin Uno

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor. If in doubt, consult a doctor or pharmacist.
The Gynoxin Uno vaginal capsules are intended for vaginal use only.
Do not take the vaginal capsules orally.
The recommended dose is:

1 soft vaginal capsule administered once. Insert deeply into the vagina in the evening before bedtime. If symptoms persist, the dose may be repeated after three days.

Children and adolescents
The recommended dose for adolescents aged 16 years and older is the same as for adults.
Use of a higher than recommended dose of Gynoxin Uno
In case of accidental ingestion of a vaginal capsule, seek immediate medical advice from a doctor or go to the nearest hospital.
Discontinuation of Gynoxin Uno
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After insertion of the capsule into the vagina, a mild, transient burning sensation may occur.
When Gynoxin Uno is used as recommended, the active substance is poorly absorbed and the occurrence of systemic adverse effects is unlikely.
Topically applied medicines, particularly when used long-term, may cause sensitization (see "Warnings and precautions" in section 2).
The following adverse reactions have been observed with this medicine:
Very rare (less than 1 in 10,000):

burning sensation of the vulva and vagina,
erythema,
itching,
rash.

Unknown (frequency cannot be estimated from available data):

local hypersensitivity at the site of application.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Gynoxin Uno

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gynoxin Uno contains

The active substance is fenticonazole. Each soft vaginal capsule contains 600 mg of fenticonazole nitrate.
The other ingredients (excipients) are: gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217), liquid paraffin, white soft paraffin, soy lecithin.

What Gynoxin Uno looks like and contents of the pack
1 soft vaginal capsule in a PVC/Al blister pack, in a cardboard box.
For more detailed information, please contact the marketing authorization holder or parallel importer.
Marketing authorization holder in Spain, country of export:
CASEN RECORDATI, S.L., Autovia de Logroño, Km. 13,300, 50180 Utebo (Zaragoza), 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 in:
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 marketing authorization number (country of export): 667907.4
Parallel import authorization number: 223/13