Gynoxin optima

Package leaflet: Information for the patient

Warning! Keep the 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 the entire 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 the patient feels worse, contact a physician.

Table of 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, 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 vaginitis and vulvitis, also known as vaginal and vulvar 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 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 speak with 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 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"),
• mechanical contraceptive methods made of latex (e.g. condoms, vaginal diaphragms) are 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 partner is also infected,
• the patient has experienced more than two infections within the last 6 months,
• the patient or her partner has ever had a sexually transmitted disease,
• the patient is allergic to the active substance or 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 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 mechanical contraceptive methods made of latex (e.g. 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 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 effect 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 (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 advised by your doctor. If in doubt, consult your 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, 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 above 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 use 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 reactions

Like all medicines, this medicine can cause adverse reactions, 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 reactions is unlikely.
Topically applied medicines, especially 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 in the vulva and vagina,
• erythema,
• itching,
• rash.

Unknown (frequency cannot be estimated from available data):

• local hypersensitivity at the site of administration.

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, 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 enables better assessment of 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 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. This will help 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 components (excipients) are: medium-chain triglycerides, colloidal anhydrous silica, gelatin, glycerol, titanium dioxide (E 171), sodium ethylparaben (E 215), sodium propylparaben (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 box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Greece, the country of export:
Recordati Hellas Pharmaceuticals AE
Zoodochou Pigis 7
152-31 Chalandri
Greece
Manufacturer
Catalent Italy S.p.A.
Via Nettunense km 20,100
04011 Aprilia (LT)
Italy
Parallel importer:
Polypharm S.A.
ul. Barska 33
02-315 Warsaw
Repackaged in:
Farmak Sp. z o.o.
ul. Nałęczowska 5A
02-922 Warsaw
Marketing authorisation numbers in Greece, the country of export: 17076/10.6.1993
8524/6.2.2007
Parallel import authorisation number: 109/23