Gynoxin optima
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Gynoxin Optima (Gynoxin)
20 mg/g (2%), vaginal cream
Fenticonazoli nitras
Gynoxin Optima and Gynoxin 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.
Table of Contents
- What Gynoxin Optima is and what it is used for
- Important information before using Gynoxin Optima
- How to use Gynoxin Optima
- Possible side effects
- How to store Gynoxin Optima
- 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 infections of the mucous membranes of the genital organs (vulvovaginal candidiasis, vaginitis,
vaginal discharge).
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 is intended for topical use only.
A reliable diagnosis of fungal infection and confirmation of microorganism sensitivity to fenticonazole
can only be made by a physician. Please refer to section 2 of this leaflet for information on when to
consult your 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, breastfeeding and fertility"),
- latex-based mechanical contraceptive methods are used concurrently (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,
- the patient is allergic to imidazole or other vaginal antifungal medicines,
- the patient is over 60 years of age,
- the patient experiences any of the following symptoms: abnormal or irregular bleeding, blood-stained vaginal discharge, vaginal or vulvar lesions including ulcers and blisters, lower abdominal or back pain, dysuria (painful urination), or adverse effects such as redness, itching or rash related to treatment.
Avoid contact with the eyes.
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 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. The applicator should not be used during pregnancy.
Driving and operating machinery
Gynoxin Optima has no influence on the ability to drive or operate machinery.
Gynoxin Optima contains
- hydrogenated lanolin and cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
- propylene glycol This medicine contains 50 mg of propylene glycol per 1 g of cream.
3. How to use Gynoxin Optima
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor. If in doubt, consult your doctor.
Insert the entire contents of the applicator (approximately 5 g) deeply into the vagina. The cream should be administered using the applicator (after washing, it is suitable for repeated use). Apply once daily deeply into the vagina in the evening before bedtime for 6 consecutive days, or twice daily – in the evening before bedtime and in the morning – for 3 consecutive days.
Children and adolescents
The recommended dose for adolescents aged 16 years and above is the same as for adults.
Instructions for administering the cream
Use only a clean applicator. After each use, wash the applicator with warm water and soap.
In exceptional cases, your doctor may recommend sterilizing the applicator.
Do not use water hotter than 50°C or organic solvents.
After washing, dry the applicator thoroughly and store it in the provided container.
Follow the instructions below (see also the figure below).
- After removing the cap, screw the applicator onto the cream tube.
- Gently squeeze the tube from the bottom to fill the applicator. If resistance is encountered when pushing the plunger, gently pull it back slightly. Unless otherwise instructed, fill the applicator completely.
- Remove the applicator from the tube, which should then be tightly closed.
- The patient should lie down with knees bent and apart; then insert the applicator deeply into the vagina. Completely empty the applicator by pressing the plunger. Remove the applicator from the vagina without moving the plunger.
In appropriate cases, the cream may also be used by the sexual partner (see "Warnings and precautions" in section 2).
Use of more than the recommended dose of Gynoxin Optima
If the vaginal cream is accidentally 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 will experience them.
After insertion of the cream into the vagina, mild, transient burning sensation may occur.
If Gynoxin Optima is used as recommended, the active substance is poorly absorbed systemically,
and the occurrence of systemic adverse effects is unlikely.
Topical 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 vulva and vagina,
- erythema,
- pruritus,
- 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, pharmacist, or nurse. 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 the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Gynoxin Optima contains
- The active substance is fenticonazole nitrate. 100 g of vaginal cream contains 2 g of fenticonazole nitrate.
- The other ingredients (excipients) are: macrogol esters with fatty acids, almond oil, propylene glycol, cetyl alcohol, glyceryl monostearate, hydrogenated lanolin, disodium edetate, purified water.
What Gynoxin Optima looks like and contents of the pack
Tube in a cardboard box. The pack contains 35 g of cream in a tube and 7 applicators (for single use).
For further information, please contact the responsible party or the parallel importer.
Responsible party in Belgium, the country of export:
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1, 20148 Milan, Italy
Manufacturer:
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1, 20148 Milan, Italy
Vamfarma S.R.L.
Via Kennedy, 5, 26833 Comazzo (Lodi), 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
Belgium, country of export, marketing authorization number: BE162504
Parallel import authorization number: 211/19