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 (Terlomexin)

200 mg, vaginal soft capsule

Fenticonazole nitrate
Gynoxin Optima and Terlomexin 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.

• The leaflet should be kept so that it can be re-read if necessary.
• If advice or additional information is needed, you should 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, 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. 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 yeast. Fenticonazole also has antibacterial effects on Gram-positive and Gram-negative bacteria.
Indications for use
Fungal inflammation of the vagina and vulva, 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 a doctor before use.
The vaginal soft capsules of Gynoxin Optima are intended for vaginal use only.

They should not be taken orally.

A reliable diagnosis of yeast 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 to determine when to discuss the use of the medicine with a doctor.

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"). 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 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 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, 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 may inactivate locally applied spermicides.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a baby, 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

• -ethyl 4-hydroxybenzoate (E 215) and propyl 4-hydroxybenzoate (E 217),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 as directed by a doctor or pharmacist.
The vaginal soft capsules of Gynoxin Optima are intended for vaginal use only.
The capsules should not be taken 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 capsule, the patient should immediately contact a 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

If there are any further doubts about the use of this medicine, the patient should 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 directed, 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).
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 any 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 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
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.
This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The medicine should not be stored at temperatures above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Gynoxin Optima is fenticonazole. 1 vaginal soft capsule contains 200 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: triglycerides of medium-chain fatty acids (MIGLYOL 812), colloidal anhydrous silica, coating: gelatin, glycerol, titanium dioxide (E 171), ethyl 4-hydroxybenzoate (E 215), propyl 4-hydroxybenzoate (E 217).

What Gynoxin Optima looks like and contents of the pack

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

Marketing authorization holder in France, the country of export:

Effik
Building "Le Newton"
9-11 Rue Jeanne Braconnier
92366 Meudon La Foret, France

Manufacturer:

Effik
Building "Le Newton"
9-11 Rue Jeanne Braconnier
92366 Meudon La Foret, France

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
French marketing authorization number, in the country of export: 3400933783310

Parallel import authorization number: 21/24

Date of leaflet approval: 16.01.2024

[Information about the trademark]