Ginoxin Optima

Leaflet attached to the packaging: information for the patient

Gynoxin Optima, 200 mg, vaginal capsule, soft

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 as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, 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 or pharmacist. 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. 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

Fungal vaginitis and vulvitis, 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.

Patient over 60 years of age should consult a doctor before using the medicine.

The vaginal capsules of Gynoxin Optima are intended for vaginal use only.

Do not take them orally.

Only a doctor can make a reliable diagnosis of a fungal infection and determine the susceptibility of the microorganism to fenticonazole. Read the information in section 2 of the leaflet to find out in which situations to talk to a doctor before using the medicine.

2. Important information before using Gynoxin Optima

When not to use Gynoxin Optima

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 (e.g., condoms, diaphragms) are used at the same time (see "Gynoxin Optima and other medicines"). It is recommended to use alternative contraceptive methods during treatment with 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 vaginal infections in the last 6 months,
• the patient or their partner has had a sexually transmitted disease,
• 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,
• ulcers or blisters on the vulva and vagina,
• lower abdominal pain, back pain, or pain when urinating,
• adverse reactions such as redness, itching, or rash, which are related to treatment.

If the partner is also infected, it is recommended that they receive treatment at the same time.

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 (e.g., condoms, diaphragms) (see "Warnings and precautions").

It is not recommended to use spermicides (substances used vaginally to immobilize sperm and used as contraception alone or with a diaphragm) 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 medicine. Gynoxin Optima should be used under medical supervision during pregnancy and breastfeeding.

Driving and using machines

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

Gynoxin Optima contains:

• - ethyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate sodium, 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. If in doubt, consult a doctor or pharmacist.

The vaginal capsules of Gynoxin Optima are intended for vaginal use only.

Do not take the vaginal capsules 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 more than the recommended dose of Gynoxin Optima

In case of swallowing a vaginal capsule, contact a doctor or go to the nearest hospital immediately.

Missing a dose of Gynoxin Optima

Do not use a double dose to make up for a missed dose.

Stopping treatment with Gynoxin Optima

If you have any further doubts about using this medicine, 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 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 allergic reactions (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, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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, you can help provide more information on the safety of this medicine.

5. How to store Gynoxin Optima

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Gynoxin Optima contains

• The active substance is fenticonazole. One vaginal capsule, soft, contains 200 mg of fenticonazole nitrate.
• The other ingredients (excipients) are: triglycerides of saturated fatty acids with a medium chain length, colloidal silica, gelatin, glycerol, titanium dioxide (E 171), ethyl 4-hydroxybenzoate (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 carton box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Civitali 1

20148 Milan

Italy

Manufacturer

Catalent Italy S.p.A.

Via Nettunense km 20, 100

04011 Aprilia (LT)

Italy

Date of last revision of the leaflet:

Detailed information on this medicine is available on the website of Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

http://urpl.gov.pl/