Gynoxin optima

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Gynoxin Optima (Lomexin)
200 mg, vaginal capsule, soft
Fenticonazoli nitras
Gynoxin Optima and Lomexin are different brand names for the same medicine.
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 the patient leaflet or as directed by a 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 or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, contact your 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 a broad spectrum of 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 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.
Gynoxin Optima vaginal capsules are 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 the leaflet for information on situations when you should speak with your doctor before using the 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"),
• mechanical contraceptive methods made of latex are used simultaneously (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 last 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 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 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 (condoms, vaginal diaphragms) (see "Warnings and precautions").
Concomitant use with spermicides (vaginally administered substances that immobilize sperm and are used for contraception alone or in combination with, e.g., 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 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 or operate machinery.
Gynoxin Optima contains:

• sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, 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 prescribed by a physician.
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 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 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 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
After insertion of the capsule into the vagina, mild, transient burning sensation may occur.
If Gynoxin Optima is used as recommended, the active substance is poorly absorbed,
and systemic adverse reactions are 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 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 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 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 enables continuous monitoring of the benefit-risk balance 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 cardboard box and
blister pack 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 the sewage system 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 pack 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, 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/PVDC/Al 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, country of export:
Recordati Hellas Pharmaceuticals ΑΕ
Zoodochou Pigis 7,
152 31 Chalandri
Greece
Manufacturer:
Catalent Italy S.p.A.,
Aprilia (LT),
Italy
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
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
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
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation numbers in Greece, country of export: 17076/10.6.1993
8524/6.2.2007
Parallel import authorisation number: 59/22