Gynoxin optima

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language
Gynoxin Optima (Terlomexin)
200 mg, vaginal soft capsule
Fenticonazoli nitras
Gynoxin Optima and Terlomexin are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet, so you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, contact your doctor.

Table of contents

1. What Gynoxin Optima is and what it is 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 pack and other information

1. What Gynoxin Optima is and what it is used for

Gynoxin Optima contains the active substance fenticonazole, an imidazole derivative with broad-spectrum antifungal activity, including against yeasts. Fenticonazole also has antibacterial activity against Gram-positive and Gram-negative bacteria.

Indications
Fungal vaginitis and vulvitis, also known as vaginal and vulval candidiasis.
Treatment of mixed vaginal infections.

Gynoxin Optima is intended for use in adults and adolescents over the age of 16. Patients over 60 years of age should consult a doctor before use.

Gynoxin Optima vaginal capsules are intended for vaginal use only.
Do not take orally.

Only a physician can reliably diagnose fungal infection and determine microbial sensitivity to fenticonazole. Please refer to section 2 of this leaflet for information on when to speak with a doctor before using this 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"),
• latex-based mechanical contraceptive methods are used simultaneously (see "Gynoxin Optima and other medicines"). During treatment with this medicine, alternative contraceptive methods are recommended,
• the patient is using spermicides, vaginal douches, or other vaginal products (see "Gynoxin Optima and other medicines"),
• allergic reactions to the medicine occur,
• symptoms do not improve within 7 days or worsen,
• the partner is also infected,
• the patient has had more than two infections within the last 6 months,
• the patient or her partner has ever had a sexually transmitted infection,
• 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,
  • bloody vaginal discharge,
  • lesions of the vagina and vulva, including ulcers and blisters,
  • pain in the lower abdomen or back, or pain during urination,
  • adverse reactions such as redness, itching, or rash related to treatment.

If the partner is also infected, 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 which may damage latex-based mechanical contraceptive methods (e.g. condoms, vaginal diaphragms) (see "Warnings and precautions").
Concurrent use with spermicides (vaginal agents that immobilize sperm and are used as contraceptives alone or in combination, e.g. with a diaphragm) is not recommended. Any local vaginal treatment may inactivate locally applied spermicidal contraceptives.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine. Gynoxin Optima should be used during pregnancy and breastfeeding only under medical supervision.
Driving and operating machinery
Gynoxin Optima has no influence on the ability to drive or operate machinery.
Gynoxin Optima contains:

• sodium ethyl para-hydroxybenzoate, sodium propyl para-hydroxybenzoate (E 217), which may cause allergic reactions (including delayed-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. If in doubt, consult a doctor or pharmacist.
Gynoxin Optima vaginal capsules are intended for vaginal use only.
Do not take the vaginal capsules orally.
The recommended dose is:

• 1 soft vaginal capsule once daily for three consecutive days. Insert deeply into the vagina in the evening before bedtime.

Children and adolescents
The recommended dose for adolescents aged 16 years and above is the same as for adults.
Taking more Gynoxin Optima than recommended
If a vaginal capsule has been swallowed, contact a doctor immediately or go to the nearest hospital.
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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
After insertion of 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 adverse reactions is unlikely.
Topical medicines, particularly when used long-term, may cause sensitisation (see "Warnings and precautions" in section 2).
The following adverse reactions have been observed with this medicine:
Very rare (less than 1 in 10,000):

• burning sensation of the vulva and vagina,
• erythema,
• itching,
• rash.

Unknown (frequency cannot be estimated from the available data):

• local hypersensitivity at the site of application.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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 adverse reactions enables better assessment of the medicine's safety profile.

5. How to store Gynoxin Optima

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must 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. Contents of the packaging and other information

What Gynoxin Optima contains

• The active substance is fenticonazole. Each soft vaginal capsule contains 200 mg of fenticonazole nitrate.
• The other components (excipients) are: medium-chain triglycerides (Miglyol 812), anhydrous colloidal silicon dioxide, gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217).

What Gynoxin Optima looks like and contents of the pack
3 soft vaginal capsules in a PVC/PVDC-Aluminum blister pack, in a cardboard carton.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in France, the country of export:
Effik
Bâtiment "Le Newton"
9-11 rue Jeanne Braconnier
92366 Meudon la Foret
France
Manufacturer:
Effik
Bâtiment "Le Newton"
9-11 rue Jeanne Braconnier
92366 Meudon la Foret
France
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing Authorization number in France, the country of export:

Parallel import licence number: 91/24