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)
600 mg, vaginal capsule, soft
Fenticonazoli nitras
Gynoxin Uno and Lomexin 600 mg are different trade names for the same medicine.
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 the patient leaflet or as advised by
the doctor or pharmacist.

• Keep this leaflet so that it can be read again if necessary.
• If advice or additional information is needed, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if the patient feels worse, contact the doctor.

Table of 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
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 above the age of 16.
Patients over the age of 60 should consult a doctor before use.
The Gynoxin Uno vaginal capsule is intended for vaginal use only. It must not be taken 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 when to speak with a 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 soy 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"),
• latex-based mechanical contraceptive methods are used concurrently (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 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 topical 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, lesions of the vagina or vulva 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 latex-based mechanical contraceptive methods (e.g. condoms, vaginal diaphragms) (see "Warnings and precautions").
Concurrent use with spermicides (substances applied vaginally to immobilize sperm and 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 effect on the ability to drive or operate machinery.
Gynoxin Uno contains:

• sodium ethyl parahydroxybenzoate 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 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
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.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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 reactions is unlikely.
Topically applied medicines, especially 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 available data):

• local hypersensitivity at the site of application.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 492 1301, Fax: +48 22 492 1309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows 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 cardboard box and
blister pack after "EXP". 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 packaging and other information

What Gynoxin Uno contains

• The active substance is fenticonazole nitrate. Each soft vaginal capsule contains 600 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: liquid paraffin, light liquid paraffin, soy 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 pack, 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
Bâtiment "Le Newton"
9-11 rue Jeanne Braconnier
92366 Meudon La Forêt
France
Manufacturer:
Effik
Bâtiment "Le Newton"
9-11 rue Jeanne Braconnier
92366 Meudon La Forêt
France
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Marketing Authorisation number in France, the country of export: 34009 337 834 8 8
337 834-8
Parallel import licence number: 234/23