Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Gynoxin Uno (Lomexin 600 mg)
600 mg, soft vaginal capsule
Fenticonazoli nitras
Gynoxin Uno and Lomexin 600 mg are different brand names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your 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, consult your doctor.

Table of Contents

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 pack 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
Vaginal mucosal candidiasis (vulvovaginitis, 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 their doctor before use.
The Gynoxin Uno vaginal capsule is intended for vaginal use only.
Do not take orally.
Only a physician can reliably diagnose fungal infection and determine microbial sensitivity to fenticonazole. Please refer to section 2 of this leaflet for information on when to consult your doctor before using this medicine.

2. 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 soya lecithin. If the patient is allergic to peanuts or soya, she must 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 being used simultaneously (see "Gynoxin Uno and other medicines"). During treatment with this medicine, alternative contraceptive methods are recommended;
the patient is using spermicides, vaginal douches or other vaginal products (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 within the last 6 months;
the patient or her partner has ever had a sexually transmitted disease;
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 or back, or pain during urination;
adverse effects such as redness, itching or rash 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 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").
Concomitant 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 contraceptive agents.
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 a 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 and operate machinery.
Gynoxin Uno contains:

sodium ethyl parahydroxybenzoate (E 215) and sodium propyl parahydroxybenzoate (E 217), which may cause allergic reactions (including delayed-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. If in doubt, 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 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 above is the same as for adults.
Use of a higher than recommended dose of Gynoxin Uno
If a vaginal capsule is accidentally swallowed, seek immediate medical advice from a doctor or go to the nearest hospital.
Stopping treatment with Gynoxin Uno
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
After insertion of 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 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 in the vulva and vagina,
erythema,
itching,
rash.

Unknown (frequency cannot be estimated from the available data):

local hypersensitivity at the application site.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of 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 effects enables more information to be gathered 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 packaging. 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Gynoxin Uno contains

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

What Gynoxin Uno looks like and contents of the pack
1 soft vaginal capsule in a PVC/PVDC/Aluminium blister, in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in France, the country of export:
EFFIK, 9-11 rue Jeanne Braconnier, 92366 Meudon La Forêt, France
Manufacturer:
EFFIK, 9-11 rue Jeanne Braconnier, 92366 Meudon La Forêt, France
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 in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorisation Number in France, the country of export: 3400933783488
337 834-8
Parallel Import Authorisation Number: 428/22