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 (Lomexin 200 mg), 200 mg, soft vaginal capsule
Fenticonazoli nitras
Gynoxin Optima and Lomexin 200 mg are different trade names for 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
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 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 you feel worse, you should contact your doctor.

Leaflet 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 vulvar candidiasis.
Treatment of mixed vaginal infections.
Gynoxin Optima is intended for use in adults and adolescents aged over 16 years.
Patients over 60 years of age should consult a doctor before use.
Gynoxin Optima is 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 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"),
• hypersensitivity reactions to the medicine occur,
• symptoms do not improve within 7 days or worsen,
• the patient's 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,
• the patient is allergic to the active substance or 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 or back, or pain during urination,
  • adverse reactions 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").
Concurrent use with spermicides (vaginal products 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 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 parahydroxybenzoate (E 215) and sodium propyl parahydroxybenzoate (E 217)
This medicine 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 directed by
your doctor. If in doubt, consult your doctor or pharmacist.
Gynoxin Optima is intended for vaginal use only.
Do not take it 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 above is the same as for adults.
Use of a higher than recommended dose of Gynoxin Optima
If the vaginal capsule is swallowed, seek medical advice 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
After insertion of the capsule into the vagina, a mild, transient burning sensation may occur.
If Gynoxin Optima is used as directed, the active substance is poorly absorbed and the occurrence of systemic adverse reactions 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 the use of this medicine:
Very rare (less than 1 in 10,000 people):

• 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, pharmacist or nurse. Adverse reactions can be reported directly to the Department for 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 to provide more information on the safety of the medicine.

5. How to store Gynoxin Optima

Keep the medicine out of the 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 specified 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. Such measures 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, cream-white in colour, in a blister made of PVC/Aluminium foil, packed in a
cardboard box.
For further detailed information, please contact the Marketing Authorisation Holder or the 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
Aprilia (LT) 04011
Italy
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 Spain, the country of export: 678961.2
Parallel Import Licence number: 198/20
Date of approval: 11.07.2025