Ginoxin Optima

Leaflet attached to the packaging: information for the patient

Warning! Keep the leaflet! 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.

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

• 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. Contents of the packaging 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 yeasts. 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 intended for topical use only.
Only a doctor can make a reliable diagnosis of a fungal infection and determine the susceptibility of the microorganism to fenticonazole. You should read the information in section 2 of the leaflet to see when you should 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, breastfeeding and fertility"),
• mechanical contraceptives made of latex are used at the same time (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"),
• 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,
• if the patient is allergic to imidazole or other vaginal antifungal medicines,
• the patient is over 60 years old,
• the patient has any of the following symptoms:
• abnormal or irregular bleeding,
• bloody discharge,
• ulcers or blisters on the vulva and vagina,
• lower abdominal pain, back pain, or pain when urinating,
• side effects such as redness, itching, or rash related to treatment.

Avoid contact of the medicine with the eyes.
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 (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, 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 during pregnancy and breastfeeding under medical supervision. 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:

• 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.
In case of doubt, consult a doctor or pharmacist.
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 at a temperature above 50°C or organic solvents.
After washing, dry the applicator and store it in the included 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.

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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 swallowing the vaginal cream, 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 cream 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.
Topical medicines, especially when used for a long time, can cause allergies (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 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 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.
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 stated.
There are no special precautions for storage.
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. Contents of the packaging 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: esters of macrogol with fatty acids, almond oil, propylene glycol, cetyl alcohol, glycerol monostearate, hydrogenated lanolin, disodium edetate, purified water.

What Gynoxin Optima looks like and what the packaging contains

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

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:

InPharm Sp. z o. o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Belgium, the country of export:BE162504

Parallel import authorization number: 130/24

Date of leaflet approval: 25.03.2024

[Information about the trademark]