Gynoxin optima

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Gynoxin Optima (Lomexin), 200 mg, vaginal capsule, soft
Fenticonazoli nitras
Gynoxin Optima and Lomexin are different trade names of 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 a physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement after 7 days, or if symptoms worsen, contact a physician.

Table of contents

1. What Gynoxin Optima is and what it is used for
2. What you need to know 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 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 a physician 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 consult a physician 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 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 had more than two infections within the past 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 of age,
• the patient experiences any of the following symptoms:
  • abnormal or irregular bleeding,
  • bloody vaginal discharge,
  • vaginal or vulvar lesions including ulcers and blisters,
  • pain in the lower abdomen or 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 contraceptive methods (condoms, vaginal diaphragms) (see "Warnings and precautions").
Concomitant use with spermicides (vaginal agents that immobilize sperm and are used as contraceptives alone or together with, for example, 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 her 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 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 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, 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 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 everyone experiences 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 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 effects have been observed with 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):

• 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 or pharmacist. Adverse effects 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, 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 blister. 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. Following this advice helps 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 ingredients (excipients) are: medium-chain triglycerides, colloidal anhydrous silica, gelatin, glycerol (E 422), titanium dioxide (E 171), sodium ethylparahydroxybenzoate (E 215), sodium propylparahydroxybenzoate (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 more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Spain, the 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, 04011 Aprilia (LT), Italy
Parallel importer:
Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Czesky Těšín, Czech Republic
Repackaged in:
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45, 31-353 Kraków
Marketing Authorisation Number in Spain, the country of export: 678961.2
Parallel Import Authorisation Number: 348/24