Gynoxin uno

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Gynoxin Uno (Lomexin), 600 mg, vaginal capsule, soft
Fenticonazoli nitras
Gynoxin Uno and Lomexin are different trade names for the same medicine.
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 a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• 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, contact 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, 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 genital mucous membranes (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 a 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 refer to section 2 of this leaflet for information on when to 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 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"),
• mechanical contraceptive methods made of latex are 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 experienced more than two infections within the past 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 of age,
• the patient experiences any of the following symptoms:
• abnormal or irregular bleeding,
• bloody vaginal discharge,
• vaginal or vulvar lesions 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 latex-based mechanical contraceptives (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 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 (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 this patient leaflet or as directed 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.
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.
Taking more Gynoxin Uno than recommended
If a vaginal capsule is swallowed, seek medical advice immediately or go to the nearest hospital.
Stopping 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 everybody 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 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 after using this medicine:
Very rare (less than 1 in 10,000):

• burning sensation in the vulva and vagina,
• erythema,
• itching,
• rash.

Unknown frequency (frequency cannot be determined 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 of 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 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl .
Reporting adverse reactions enables the collection of further 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. These 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. Capsule shell: gelatin, glycerol (E 422), titanium dioxide (E 171), sodium ethylparahydroxybenzoate (E 215), sodium propylparahydroxybenzoate (E 217).

What Gynoxin Uno looks like and contents of the pack
1 soft vaginal capsule in a PVC/Aluminum blister, in a cardboard box.
For more detailed information, please contact the responsible entity or parallel importer.
Marketing Authorisation Holder in Spain, country of export:
Casen Recordati, S.L.
Autovía de Logroño, Km. 13,300
50180 Utebo (Zaragoza), Spain
Manufacturer:
Catalent Italy S.p.A.
Via Nettunense, Km 20, 100
Aprilia (LT) 04011, 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 Spain, country of export: 667907.4
Parallel Import Authorisation Number: 407/22