Ginoxin Optima

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.

Gynoxin Optima (Lomexin), 200 mg, vaginal soft capsule

Fenticonazole nitrate
Gynoxin Optima and Lomexin are different trade names for the same drug.

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 the patient leaflet or according to the doctor's or pharmacist's instructions.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Gynoxin Optima and what is it used for
• 2. Important information before using Gynoxin Optima
• 3. How to use Gynoxin Optima
• 4. Possible side effects
• 5. How to store Gynoxin Optima
• 6. Package contents and other information

1. What is Gynoxin Optima and what is it used for

Gynoxin Optima contains the active substance fenticonazole, which is an imidazole derivative with a broad spectrum of antifungal activity, including against yeast. Fenticonazole also has antibacterial effects on Gram-positive and Gram-negative bacteria.
Indications for use
Fungal vaginitis and vulvitis, also known as vaginal and vulvar yeast infection.
Treatment of mixed vaginal infections.
Gynoxin Optima is intended for use in adults and adolescents over 16 years of age.
Patients over 60 years of age should consult their doctor before using the medicine.
The vaginal soft capsules of Gynoxin Optima are intended for vaginal use only.

Do not take them orally.

Only a doctor can reliably diagnose a fungal infection and determine the susceptibility of the microorganism to fenticonazole. Read the information in section 2 of the leaflet to see when to talk to your doctor before using the medicine.

2. Important information before using Gynoxin Optima

When not to use Gynoxin Optima

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Using Gynoxin Optima should be discussed with a doctor or pharmacist if:

• the patient is pregnant or breastfeeding (see "Pregnancy and breastfeeding and fertility"),
• mechanical contraceptives made of latex are used at the same time (see "Gynoxin Optima and other medicines"). It is recommended to use alternative contraceptive methods during treatment with this medicine,
• the patient uses spermicides, vaginal douches, or other vaginal products (see "Gynoxin Optima and other medicines"),
• hypersensitivity reactions to the medicine occur,
• symptoms do not decrease 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 their partner has had a sexually transmitted disease,
• if the patient is allergic to the active substance or any of the other ingredients of this medicine,
• the patient is over 60 years old,
• the patient experiences any of the following symptoms:
• abnormal or irregular bleeding,
• blood-stained discharge,
• lesions and blisters on the vulva and vagina,
• lower abdominal pain, back pain, or pain when urinating,
• adverse reactions such as redness, itching, or rash, which are related to treatment.

If the partner is also infected, it is recommended that they be treated at the same time.

Children and adolescents

Gynoxin Optima is not intended for use in children and adolescents under 16 years of age.

Gynoxin Optima and other medicines

Gynoxin Optima contains fats and oils that can damage latex contraceptives (condoms, diaphragms) (see "Warnings and precautions").
It is not recommended to use spermicides (substances used vaginally that immobilize sperm and are used as contraception alone or together, e.g., with a diaphragm) at the same time. Any local vaginal treatment can inactivate locally used spermicides.

Pregnancy and breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. Gynoxin Optima should be used under medical supervision during pregnancy and breastfeeding.

Driving and using machines

Gynoxin Optima has no effect on the ability to drive and use machines.

Gynoxin Optima contains:

• - ethyl parahydroxybenzoate and propyl parahydroxybenzoate sodium, which may cause allergic reactions (possible late-type reactions).

3. How to use Gynoxin Optima

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.
In case of doubt, consult a doctor or pharmacist.
The vaginal soft capsules of Gynoxin Optima are intended for vaginal use only.
Do not take the vaginal soft capsules orally.
The recommended dose is:

• 1 vaginal soft capsule, used once a day for three consecutive days. Insert deeply into the vagina in the evening before bedtime.

Children and adolescents
The recommended dose for adolescents over 16 years of age is the same as for adults.

Using a higher dose of Gynoxin Optima than recommended

In case of swallowing a vaginal soft capsule, contact a doctor or go to the nearest hospital immediately.

Missing a dose of Gynoxin Optima

Do not use a double dose to make up for a missed dose.

Stopping treatment with Gynoxin Optima

If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Gynoxin Optima can cause side effects, although not everybody gets them.
After inserting the capsule into the vagina, a mild, transient burning sensation may occur.
If Gynoxin Optima is used as recommended, the active substance is poorly absorbed, and the occurrence of systemic side effects is unlikely.
Locally used medicines, especially when used for a long time, can cause hypersensitivity (see "Warnings and precautions" in section 2).
After using this medicine, the following side effects have been observed:
Very rare(less than 1 in 10,000):

• burning sensation of the vulva and vagina,
• redness,
• itching,
• rash.

Unknown(frequency cannot be estimated from the available data):

• hypersensitivity at the application site.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects can help gather more information on the safety of the medicine.

5. How to store Gynoxin Optima

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Gynoxin Optima contains

• The active substance of the medicine is fenticonazole. 1 vaginal soft capsule contains 200 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: medium-chain triglycerides, colloidal anhydrous silica, capsule shell: gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217).

What Gynoxin Optima looks like and contents of the pack

3 vaginal soft capsules in a blister pack of PVC/Aluminum in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the 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, 04011 Aprilia (LT), Italy

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Spanish authorization number, country of export:678961.2
Parallel import authorization number:176/19
Date of leaflet approval: 27.05.2022
[Information about the trademark]