Gynoxin optima

Package leaflet: Information for the patient

NOTE: Keep this leaflet, information on the immediate packaging in a foreign language.
Gynoxin Optima (Lomexin), 200 mg, vaginal capsule, soft
Fenticonazole nitrate
Gynoxin Optima and Lomexin are different trade 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 doctor or pharmacist.

• Keep this leaflet to be able to read it again if necessary.
• If advice or additional information is needed, please consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, consult a doctor.

Table of contents of the leaflet

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 for use
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 above the age of 16.
Patients over the age of 60 should consult a doctor before use.
Gynoxin Optima vaginal capsules are intended for vaginal use only.
Do not take orally.
Only a doctor can reliably diagnose a fungal infection and confirm the microorganism's sensitivity to fenticonazole. Please refer to section 2 of this leaflet for information on situations when you should 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 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 and breastfeeding and effect on fertility"),
• latex-based mechanical contraceptive methods are being used simultaneously (see "Gynoxin Optima and other medicines"). Alternative contraceptive methods are recommended during treatment with this medicine,
• the patient is using 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 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 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 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 (vaginal agents that immobilize sperm and are used as contraception alone or in combination, e.g., with a diaphragm) is not recommended. Any local vaginal treatment may inactivate locally applied spermicidal contraceptive agents.
Pregnancy and breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 and sodium propyl parahydroxybenzoate, which may cause allergic reactions (delayed-type reactions possible).

3. How to use Gynoxin Optima

This medicine should always be used exactly as described in this 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 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 regarding 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 everybody will experience them.
After insertion of the capsule into the vagina, a mild, transient burning sensation may occur.
If Gynoxin Optima is used according to recommendations, the active substance is poorly absorbed
and the occurrence of systemic adverse effects is unlikely.
Topically applied 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 available data):

• local hypersensitivity at the site of application.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 outer carton and
blister after "EXP". 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. This will 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 components (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 contained in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Spain, the country of export:
Casen Recordati, S.L., Autovía de Logroño, km 13.300, 50180 UTEBO, Zaragoza, Spain
Manufacturer:
Catalent Italy S.p.A., Via Nettunense, Km 20, 100, 04011 Aprilia (LT), Italy
Parallel Importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna
Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa
Marketing Authorisation Number in Spain, the country of export: 678961.2
Parallel Import Licence Number: 176/19