Gynoxin optima

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Gynoxin Optima (Terlomexin)
200 mg, vaginal capsule, soft
Fenticonazoli nitras
Gynoxin Optima and Terlomexin are different trade names for the same medicinal product.
Please read the entire 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
your doctor or pharmacist.

• Keep this leaflet so that 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, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days, or if you feel worse, you should 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, which is 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 infection of the vagina and vulva, also known as vaginal and vulval candidiasis.
Treatment of mixed vaginal infections.
Gynoxin Optima is intended for use in adults and adolescents above the age of 16. Patients over 60 years of age should consult their doctor before use.
Gynoxin Optima vaginal capsules are intended for vaginal use only.
Do not take orally.
Only a doctor 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 to any of the other components 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 contraceptive methods made of latex are being 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 experienced more than two infections within the last 6 months,
• the patient or her partner has ever had a sexually transmitted infection,
• if the patient is allergic to the active substance or to any of the other components of this medicine,
• the patient is over 60 years of age,
• 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, back, or pain during urination,
  • adverse effects 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 mechanical contraceptive methods made of latex (condoms, vaginal diaphragms) (see "Warnings and precautions").
Concurrent use with spermicides (vaginally administered substances that immobilize sperm and are used for contraception 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 p-hydroxybenzoate (E 215) and sodium propyl p-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 this patient leaflet or as advised by your doctor. If in doubt, consult your doctor or pharmacist.
The Gynoxin Optima vaginal capsules are intended for vaginal use only.
Do not take the vaginal capsules orally.

Recommended dose:

• 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 older is the same as for adults.

Overdose of Gynoxin Optima
If a vaginal capsule is swallowed, contact a doctor immediately or go to the nearest hospital.

Missed 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
After insertion of the capsule into the vagina, mild, transient burning sensation may occur.
If Gynoxin Optima is used according to recommendations, the active substance is poorly absorbed
systemically, and occurrence of systemic adverse effects is unlikely.
Topical medicines, especially when used long-term, may cause sensitization (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 vulva and vagina,
• erythema,
• itching,
• rash.

Unknown (frequency cannot be estimated from available data):

• local hypersensitivity at the site of administration.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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 effects helps to provide more information on the safety of the medicine.

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 packaging. 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 pack 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, capsule shell: gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217).

What Gynoxin Optima looks like and contents of the pack
3 soft vaginal capsules in a PVC/PVDC - Aluminium blister pack, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in France, the country of export: 3400933783310
Parallel Import Authorisation Number: 21/24