Ginoxin Optima

Leaflet attached to the packaging: patient information

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

Gynoxin Optima (Lomexin)

200 mg, vaginal capsule, soft

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

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

This drug 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. 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.
Patient over 60 years of age should consult a doctor before using the drug.
The vaginal capsules of Gynoxin Optima are intended for vaginal use only.

They should not be taken orally.

Only a doctor can reliably diagnose 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 in which situations you should talk to your doctor before using the drug.

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 drug (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 drugs"). During the use of this drug, alternative contraceptive methods are recommended,
• the patient uses spermicides, vaginal douches, or other vaginal products (see "Gynoxin Optima and other drugs"),
• there are signs of hypersensitivity to the drug,
• 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 drug,
• the patient is over 60 years old,
• the patient experiences any of the following symptoms:
• abnormal or irregular bleeding,
• blood-stained 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 drugs

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 at the same time. Any local vaginal treatment can inactivate locally applied 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 drug. 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 sodium (E 215) and propyl 4-hydroxybenzoate sodium (E 217),which may cause allergic reactions (possible late-type reactions).

3. How to use Gynoxin Optima

This drug should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.
The vaginal capsules of Gynoxin Optima are intended for vaginal use only.
The vaginal 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, 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

In case of further doubts about the use of this drug, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all drugs, 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 applied drugs, especially when used for a long time, can cause hypersensitivity (see "Warnings and precautions" in section 2).
After using this drug, 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 doctor, pharmacist, or nurse should be informed. 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, more information can be collected on the safety of the drug.

5. How to store Gynoxin Optima

The drug should be stored out of sight and reach of children.
The drug should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store at a temperature below 30°C.
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. Contents of the packaging and other information

What Gynoxin Optima contains

• The active substance of the drug is fenticonazole. 1 vaginal capsule, soft, contains 200 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: triglycerides of medium-chain fatty acids, anhydrous colloidal silica, capsule shell: gelatin, glycerol (E 422), titanium dioxide (E 171), ethyl 4-hydroxybenzoate sodium (E 215), propyl 4-hydroxybenzoate sodium (E 217).

What Gynoxin Optima looks like and what the packaging contains

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

Marketing authorization holder in Latvia, the country of export:

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

Manufacturer:

Catalent Italy SpA, via Nettunense Km. 20, 100-04011 Aprilia (LT), 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
Marketing authorization number in Latvia, the country of export: 04-0143

Parallel import authorization number: 24/25

Date of approval of the leaflet: 20.01.2025

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