Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Gynoxin Optima (Lomexin)
200 mg, soft vaginal capsules
Fenticonazoli nitras
Gynoxin Optima and Lomexin are different brand names of 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 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 side effects 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

What Gynoxin Optima is and what it is used for
Important information before using Gynoxin Optima
How to use Gynoxin Optima
Possible side effects
How to store Gynoxin Optima
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 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 over 16 years of age.
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 your 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 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 uses 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 disease,
if the patient is allergic to the active substance or to 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, 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 latex-based mechanical contraceptives (condoms, vaginal diaphragms) (see "Warnings and precautions").
Simultaneous use with spermicides (vaginal agents that immobilize sperm and are used as contraception alone or together with, e.g., a diaphragm) is not recommended. Any local vaginal treatment may inactivate locally applied contraceptive spermicides.
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 and operate machinery.
Gynoxin Optima contains:

sodium ethyl parahydroxybenzoate (E 215) and sodium propyl parahydroxybenzoate (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 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.
The recommended dose is:

1 soft vaginal capsule, administered 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.
Taking more Gynoxin Optima than recommended
If a vaginal capsule is swallowed, seek immediate medical advice from a doctor or go to the nearest hospital.
If you miss a dose of Gynoxin Optima
Do not use a double dose to make up for a missed dose.
Stopping Gynoxin Optima
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
After insertion of the capsule into the vagina, mild, transient burning sensation may occur.
When 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 sensitization (see "Warnings and precautions" in section 2).
The following adverse reactions have been observed with the use of this medicine:
Very rare (less than 1 in 10,000):

burning sensation in the vulva and vagina,
erythema,
itching,
rash.

Unknown (frequency cannot be estimated from 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 this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What Gynoxin Optima contains

The active substance is fenticonazole. Each soft vaginal capsule contains 200 mg of fenticonazole nitrate.
The other ingredients (excipients) are: medium-chain triglycerides, 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/Aluminum blister pack, in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Spain, country of export:
Casen Recordati, S.L.
Autovía de Logroño, Km. 13,300 - 50180 Utebo (Saragossa)
Spain
Manufacturer:
Catalent Italy, S.P.A.
Via Nettunense, Km 20,100
Aprilia (LT) 04011
Italy
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in Spain, country of export: 678961.2
Parallel Import Authorisation number: 149/19