Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
GYNOXIN UNO (Lomexin 600 mg)
600 mg, vaginal capsule, soft
Fenticonazoli nitras
Gynoxin Uno and Lomexin 600 mg are different trade names of the same medicinal product written in Polish and Bulgarian.
Please read the entire 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 the physician or pharmacist.

Keep this leaflet for future reference.
If advice or additional information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
If there is no improvement after 7 days or if the patient feels worse, contact a physician.

Table of 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 pack and other information

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

Gynoxin Uno contains the active substance fenticonazole, which is 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 aged above 16 years.
Patients over 60 years of age should consult a physician 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 situations when you should speak with a physician 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 soya lecithin. If the patient is allergic to peanuts or soya, 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 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 infection,
the patient is allergic to imidazole or other topical antifungal medicines,
the patient is over 60 years old,
the patient experiences any of the following symptoms: abnormal or irregular bleeding, blood-stained discharge, genital ulcers or sores including erosions and blisters, lower abdominal or back pain, pain during urination, or 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").
Concurrent use with spermicides (vaginal agents that immobilize sperm and are used as contraception alone or in combination, e.g. with 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 have a child, 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 (including delayed-type reactions).

3. How to use Gynoxin Uno

This medicine should always be used exactly as described in this patient leaflet or as directed by a physician.
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 older 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.
Discontinuation of 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 everyone experiences 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.
Topical 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 site of application.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, Phone: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

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. These measures 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: liquid paraffin, white vaseline, soy lecithin, gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate (E 215), 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 pack, in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Bulgaria, 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:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Cesky Tesin
Czech Republic
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Bulgaria, country of export: 20040138
Parallel Import Licence Number: 193/22