Gynoxin uno

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 medicine.
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 this patient leaflet or as advised by
the 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 adverse reactions not listed in this leaflet, tell 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

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, 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 for use
Vulvovaginal candidiasis (inflammation of the vulva and vagina, 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 the age of 60 should consult their 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 read the information in section 2 of the leaflet regarding situations in which you should speak to your 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 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 with other medicines"). Alternative contraceptive methods are recommended during treatment with this medicine,
• spermicides, vaginal douches or other vaginal products are being used (see "Gynoxin Uno with 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 experienced 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 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 or vulva including ulcers and blisters, pain in the lower abdomen or back, pain during urination, or adverse reactions 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 with other medicines
Gynoxin Uno contains fats and oils which may damage mechanical contraceptive methods made of latex (condoms, vaginal diaphragms) (see "Warnings and precautions").
The simultaneous 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 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 her 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 and use machines.
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 advised by your doctor. If in doubt, consult your doctor or pharmacist.
The Gynoxin Uno vaginal capsules are intended for vaginal use only. Do not take the vaginal capsules orally.
Recommended dose:

• 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 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 everyone will experience them.
After insertion of the capsule into the vagina, mild, transient burning sensation may occur.
If Gynoxin Uno is used as recommended, the active substance is poorly absorbed and systemic adverse effects are unlikely.
Topical medicines, particularly when used long-term, may cause sensitisation (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):

• hypersensitivity at the site of application.

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 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.
Store below 30 °C. Keep in the original packaging.
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 package 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: light liquid paraffin, white vaseline, soy lecithin, gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

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 further information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Romania, the country of export:
Recordati S.P.A.
Via M. Civitali 1
20148 Milan (MI)
Italy
Manufacturer:
Catalent Italy S.p.A
Via Nettunense Km 2
100, 04011 Aprilia (LT)
Italy
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Romania, the country of export: 7594/2015/01
Parallel import licence number: 289/23