Gynoxin uno

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Gynoxin Uno (Gynoxin)
600 mg, globule
Fenticonazoli nitras
Gynoxin Uno and Gynoxin are different trade 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
the physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents

1. What Gynoxin Uno is and what it is 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 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
Fungal infection of the mucous membranes of the genital organs (vulvovaginal candidiasis, vaginitis, vaginal discharge).
Treatment of mixed vaginal infections.
Gynoxin Uno is intended for use in adults and adolescents aged over 16 years.
Patients over 60 years of age should consult their doctor before use.
The Gynoxin Uno globule 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 read the information in section 2 of this leaflet regarding 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 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,
• spermicides, vaginal douches 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 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 of age,
• the patient experiences any of the following symptoms: abnormal or irregular bleeding, bloody vaginal discharge, vaginal or genital lesions including ulcers and blisters, pain in the lower abdomen or back, 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 (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 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 using machines
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 the patient leaflet or as directed by a doctor.
If in doubt, consult a doctor or pharmacist.
Gynoxin Uno globules are intended for vaginal use only.
Do not take the globules orally.
The recommended dose is:

• 1 globule, 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 globule is 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 reactions

Like any medicine, this medicine may cause adverse reactions, although they do not occur in everyone.
After insertion of the globule into the vagina, a mild, transient burning sensation may occur.
If Gynoxin Uno is used according to recommendations, the active substance is poorly absorbed and
the occurrence of systemic adverse reactions is unlikely.
Topical medicines, especially when used long-term, may cause sensitization (see "Warnings and precautions" in section 2).
The following adverse reactions have been observed with the use of 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 available data):

• hypersensitivity at the application site.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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
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 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. This will help protect the environment.

6. Contents of the package and other information

What Gynoxin Uno contains

• The active substance is fenticonazole. Each globule contains 600 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: liquid paraffin, white vaseline, soy lecithin, gelatin, glycerol, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

What Gynoxin Uno looks like and contents of the pack
1 globule in a blister pack, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Belgium, country of export:
Recordati Industria Chimica e Farmaceutica S.p.A., Via Matteo Civitali 1, 20148 Milan, Italy
Manufacturer:
Catalent Italy S.p.A., Via Nettunense Km 20,100, 04011 Aprilia (LT), Italy
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in Belgium, country of export: BE162522
Parallel import authorisation number: 138/25