Ginoxin Optima

Leaflet attached to the packaging: information for the patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language.

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

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

You should carefully read the contents of the leaflet 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 directed by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement 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 activity against Gram-positive and Gram-negative bacteria.
Indications for use
Vaginal and vulvar fungal infections, also known as vaginal and vulvar yeast infections. Treatment of mixed vaginal infections.
Gynoxin Optima is intended for use in adults and adolescents over 16 years of age.
Patient over 60 years of age should consult a doctor before using the medicine.
The vaginal capsules of Gynoxin Optima are intended for vaginal use only.

They should not be taken orally.

A reliable diagnosis of fungal infection and determination of the susceptibility of the microorganism to fenticonazole can only be made by a doctor. You should read the information in section 2 of the leaflet, in which situations to discuss with 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

The use of Gynoxin Optima should be discussed with a doctor or pharmacist if:

• the patient is pregnant or breastfeeding (see "Pregnancy, breastfeeding, and fertility"),
• mechanical contraceptives made of latex are used concurrently (see "Gynoxin Optima and other medicines"). During the use of this medicine, alternative contraceptive methods are recommended,
• 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,
• bleeding discharge,
• lesions and ulcers of the vagina and vulva,
• lower abdominal pain, back pain, or pain when urinating,
• adverse reactions such as redness, itching, or rash, which are related to treatment.

In the case of infection of the partner, concurrent treatment is recommended.

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 condoms and diaphragms (see "Warnings and precautions").
Concurrent use with spermicides is not recommended (substances used vaginally that immobilize sperm and are used as contraception alone or together, e.g., with a diaphragm). Any local vaginal treatment can inactivate spermicides used locally.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a 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:

• - sodium ethyl parahydroxybenzoate (E 215) and sodium propyl parahydroxybenzoate (E 217), which may cause allergic reactions (possible late reactions).

3. How to use Gynoxin Optima

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
The vaginal capsules of Gynoxin Optima are intended for vaginal use only.
The vaginal capsules should not be taken orally.
The recommended dose is:

• 1 vaginal capsule, soft, 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 capsule, you should immediately contact a doctor or go to the nearest hospital.

Missing a dose of Gynoxin Optima

You should not use a double dose to make up for a missed dose.

Stopping the use of Gynoxin Optima

In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 directed, 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, you should tell 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gynoxin Optima

The medicine should be stored 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 month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should 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 capsule, soft, contains 200 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: triglycerides of medium-chain fatty acids, anhydrous colloidal silica, gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217).

What Gynoxin Optima looks like and what the package contains

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

Marketing authorization holder in Greece, the country of export:

Recordati Hellas Pharmaceuticals AE
Zoodochou Pigis 7
152-31 Chalandri
Greece

Manufacturer

Catalent Italy S.p.A.
Via Nettunense km 20, 100
04011 Aprilia (LT)
Italy

Parallel importer:

Polypharm S.A.
ul. Barska 33
02-315 Warsaw

Repackaged by:

Farmak Sp. z o.o.
ul. Nałęczowska 5A
02-922 Warsaw
Marketing authorization number in Greece, the country of export:17076/10.6.1993
8524/6.2.2007

Parallel import authorization number: 109/23

Date of leaflet approval: 12.06.2023

[Information about the trademark]