Ginoxin Optima

Leaflet attached to the packaging: information for the patient

Gynoxin Optima, 20 mg/g (2%), vaginal cream

Fenticonazole nitrate

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.

• This leaflet should be kept in case it needs to be read again.
• 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, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 7 days or the patient feels worse, the doctor should be contacted.

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.
Patient over 60 years of age should consult a doctor before using the medicine.
Gynoxin Optima is for vaginal use only.
Only a doctor can make a reliable diagnosis of a fungal infection and determine the susceptibility of the microorganism to fenticonazole. 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 has experienced 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 when urinating, 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, 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-based mechanical contraceptives (condoms, diaphragms) (see "Warnings and precautions").
It is not recommended to use spermicides at the same time. Any local vaginal treatment may inactivate spermicides used locally.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a 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 does not affect the ability to drive or use machines.

Gynoxin Optima contains:

• - hydrogenated lanolin and cetyl alcohol, which can cause local skin reactions (e.g., contact dermatitis). This 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 or pharmacist's instructions. If in doubt, the doctor or pharmacist 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 reused). 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

Only use 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 unscrewing 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 when pushing the applicator, gently pull it. 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 bent and spread knees; 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 accidental ingestion of the vaginal cream, the doctor or the nearest hospital should be contacted immediately.

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

If there are any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine 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.
Locally used 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 any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Gynoxin Optima

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

6. Package contents and other information

What Gynoxin Optima contains

• The active substance of the medicine is fenticonazole. 100 g of vaginal cream contains 2 g of fenticonazole nitrate.
• The other ingredients (excipients) are: macrogol esters with fatty acids (C12-C18), first-pressing almond oil, propylene glycol, cetyl alcohol, glycerol monostearate, hydrogenated lanolin, disodium edetate, purified water.

What Gynoxin Optima looks like and what the package contains

An aluminum tube coated internally with epoxyphenolic resin, closed with a plastic screw cap, in a cardboard box. The package contains 30 g of cream in a tube and an applicator placed in a transparent plastic container.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

VAMFARMA S.R.L.
Via Kennedy, 5
26833 Comazzo (LO)
Italy

Date of the last update of the leaflet:

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
http://urpl.gov.pl/