Ginoxin Optima

Leaflet attached to the packaging: information for the patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Gynoxin Optima (Gynoxin)

20 mg/g (2%), vaginal cream

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

It is necessary to 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 according to the doctor's or pharmacist's instructions.

• The leaflet should be kept so that it can be read again if needed.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 activity against Gram-positive and Gram-negative bacteria.
Indications for use
Vaginal yeast infections (vulvovaginitis, vaginitis, leukorrhea).
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.
Gynoxin Optima is intended for topical use only.
A reliable diagnosis of fungal infection and determination of the microorganism's sensitivity to fenticonazole can only be made by a doctor. The information in section 2 of the leaflet should be read to determine when to consult a 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 at the same time (see "Gynoxin Optima and other medicines"). Alternative contraceptive methods are recommended during the use of this medicine,
• the patient uses spermicides, vaginal douches, or other vaginal products (see "Gynoxin Optima and other medicines"),
• there are signs of hypersensitivity to the medicine,
• 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,
• the patient is allergic to imidazole or other antifungal vaginal medicines,
• the patient is over 60 years old,
• the patient experiences any of the following symptoms: abnormal or irregular bleeding, bloody discharge, vaginal and vulvar lesions, including ulcers and blisters, lower abdominal pain, back pain, or pain during urination, side effects such as redness, itching, or rash, which are related to treatment.

Eye contact with the medicine should be avoided.
If the partner is also infected, their simultaneous 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 contraceptives (condoms, diaphragms) (see "Warnings and precautions").
It is not recommended to use spermicides at the same time. 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 their doctor before using this medicine. Gynoxin Optima should be used under medical supervision during pregnancy and breastfeeding. The applicator should not be used during pregnancy.

Driving and using machines

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

Gynoxin Optima contains

• -hydrogenated lanolin and cetyl alcohol,which can cause local skin reactions (e.g., contact dermatitis).
• -propylene glycolThis medicine contains 50 mg of propylene glycol in 1 g of cream.

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 instructions. In case of doubt, the doctor should be consulted.
Insert the contents of the applicator (about 5 g) deeply into the vagina. The cream should be used with the applicator (which can be washed and used multiple times). Apply once a day, in the evening before bedtime, for 6 consecutive days, or twice a day, in the evening before bedtime and in the morning, for 3 consecutive days.
Children and adolescents
The recommended dose for adolescents over 16 years of age is the same as for adults.

Instructions for administering the cream

Use only a clean applicator. After each use, wash the applicator with warm water and soap.
The doctor may recommend sterilizing the applicator in exceptional cases.
Do not use water above 50°C or organic solvents.
After washing, dry the applicator and store it in the provided container.
Follow the instructions below (see also the diagram below).

• 1. After removing the cap, screw the applicator onto the tube of cream.
• 2. Squeeze the tube gently at the bottom to fill the applicator. If there is resistance in the applicator plunger, pull it gently. If there are no other dosage instructions, fill the applicator completely.
• 3. Remove the applicator from the tube, which should then be tightly closed.
• 4. The patient should lie with their knees bent and apart; then, insert the applicator deeply into the vagina. Empty the applicator completely by pressing the plunger. Remove the applicator from the vagina without moving the plunger.

In appropriate cases, it is possible to use the cream on the sexual partner (see "Warnings and precautions" in section 2).

Using more than the recommended dose of Gynoxin Optima

In case of ingestion of the vaginal cream, the patient should immediately contact their doctor or go to the nearest hospital.

Missing a dose of Gynoxin Optima

A double dose should not be used to make up for a missed dose.

Stopping the use of Gynoxin Optima

In case of further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gynoxin Optima can cause side effects, although not everybody gets them.
After inserting the cream into the vagina, a mild, transient burning sensation may occur.
If Gynoxin Optima is used according to the instructions, the active substance is poorly absorbed, and the occurrence of systemic side effects is unlikely.
Topical medicines, especially when used for a long time, can cause hypersensitivity (see "Warnings and precautions" in section 2).
The following side effects have been observed after using this medicine:
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 side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the 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

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Gynoxin Optima contains

• The active substance of the medicine is fenticonazole nitrate. 100 g of vaginal cream contains 2 g of fenticonazole nitrate.
• The other ingredients (excipients) are: macrogol esters of fatty acids, almond oil, propylene glycol, cetyl alcohol, glycerol monostearate, hydrogenated lanolin, disodium edetate, purified water.

What Gynoxin Optima looks like and what the package contains

Tube in a cardboard box. The package contains 35 g of cream in a tube and 7 applicators (for single use).
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Belgium, the country of export:

Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1, 20148 Milan, Italy

Manufacturer:

Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1, 20148 Milan, Italy
Vamfarma S.R.L.
Via Kennedy, 5, 26833 Comazzo (Lodi), Italy

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Belgian marketing authorization number, in the country of export: BE162504

Parallel import authorization number: 211/19

Date of leaflet approval: 06.05.2024

[Information about the trademark]