Package leaflet: Information for the patient

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

Keep this leaflet, as you may need to read it again.
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, pharmacist, or nurse. See section 4.
If there is no improvement after 7 days or if your condition worsens, 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 vulvar candidiasis.
Treatment of mixed vaginal infections.
Gynoxin Optima is intended for use in adults and adolescents above the age of 16.
Patients over the age of 60 should consult their doctor before use.
The Gynoxin Optima vaginal capsules are intended for vaginal use only.
Do not take orally.
Only a physician can reliably diagnose a fungal infection and determine microbial sensitivity to fenticonazole. Please refer to section 2 of this leaflet for information on situations in which you should 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 concurrently (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"),
hypersensitivity 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 past 6 months,
the patient or her partner has ever had a sexually transmitted infection,
the patient is allergic to the active substance or to any of the other ingredients 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 reactions such as redness, itching or rash associated with 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").
Concurrent use with spermicides (vaginally administered substances that immobilize sperm and are used as contraception alone or together with, for example, 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 or 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 prescribed by a doctor.
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 by mouth.
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 older is the same as for adults.
Use of a higher than recommended dose of Gynoxin Optima
If a vaginal capsule is swallowed, seek immediate medical advice from a doctor 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 doubts about using 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 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 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 not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps 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 month indicated.
Store below 30°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 package and other information

What Gynoxin Optima contains

The active substance is fenticonazole. One soft vaginal capsule contains 200 mg of fenticonazole nitrate.
The other ingredients (excipients) are: medium-chain triglycerides, colloidal anhydrous silica, capsule shell: gelatin, glycerol (E 422), 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 carton.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Latvia, 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Latvia, country of export: 04-0143
Parallel Import Authorisation Number: 24/25