Gynoxin uno

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, 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, 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 over 16 years of age.
Patients over 60 years of age should consult their doctor 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 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 components 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 uses 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 in 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,
• lower abdominal or back pain, or pain during urination,
• adverse reactions such as: redness, itching or rash, associated with 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").
Simultaneous use with spermicides (vaginal substances 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 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 the 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.
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.
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 reactions

Like all medicines, this medicine can cause adverse reactions, 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 according to recommendations, the active substance is poorly absorbed and
systemic adverse reactions are 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 of 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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
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. Such measures help protect the environment.

6. Contents of the package and other information

What Gynoxin Uno contains

• The active substance is fenticonazole. One soft vaginal capsule contains 600 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: light liquid paraffin, white vaseline, soybean 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/Aluminum blister pack, in a cardboard carton.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the 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:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Marketing Authorisation Number in Bulgaria, the country of export: 20040138
Parallel Import Authorisation Number: 32/23