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 (Terlomexin)

200 mg, vaginal capsule, soft

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

• You should keep this leaflet so that you can read it again if necessary.
• 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, pharmacist, or nurse. 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 yeast. Fenticonazole also has antibacterial effects on 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. Patients over 60 years of age should consult a doctor before use.
The vaginal capsules of Gynoxin Optima are intended for vaginal use only.

They should not be taken orally.

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 find out in which situations 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

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"),
• 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 in the past,
• 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, 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 mechanical contraceptives (condoms, vaginal 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.

Driving and using machines

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

Gynoxin Optima contains:

• E 215 (ethyl 4-hydroxybenzoate sodium)and E 217 (propyl 4-hydroxybenzoate sodium), 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 according to the doctor's or pharmacist's instructions.
The vaginal capsules of Gynoxin Optima are intended for vaginal use only.
The 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

If you have any further doubts about using this medicine, you 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 recommended, 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, 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.
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help to 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.
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 25°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. Contents of the packaging and other information

What Gynoxin Optima contains

• The active substance of Gynoxin Optima is fenticonazole. 1 vaginal capsule, soft, contains 200 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: medium-chain triglycerides (Miglyol 812), colloidal anhydrous silica, gelatin, glycerol, titanium dioxide (E 171), ethyl 4-hydroxybenzoate sodium (E 215), propyl 4-hydroxybenzoate sodium (E 217).

What Gynoxin Optima looks like and contents of the pack

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 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:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
ul. Działkowa 56
02-234 Warsaw
87-100 Toruń
95-054 Ksawerów
Authorization number in France, the country of export:34009 337 833 1 0

Parallel import authorization number: 390/24

Date of leaflet approval: 12.11.2024

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