GYNAZOL, 20 mg/g, vaginal cream
Butoconazole nitrate
important information for the patient.
Gynazol vaginal cream is indicated for the local treatment of vulvovaginal candidiasis caused by Candida albicans.
If the patient is allergic to butoconazole or any of the other ingredients of this medicine (listed in section 6).
The efficacy and safety of Gynazol in pregnant women and children have not been established.
Before starting treatment with Gynazol, consult a doctor or pharmacist.
The efficacy and safety of Gynazol in children and adolescents have not been established.
Inform the doctor or pharmacist about all medicines currently being taken or recently taken, as well as any medicines planned to be taken.
Gynazol contains mineral oil, which may damage products made of latex or rubber, such as condoms or vaginal diaphragms.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Gynazol can be used during pregnancy only on the advice and under the close supervision of a doctor.
It is not known whether the active substance of Gynazol passes into breast milk. Therefore, the doctor should always be consulted before using this medicine during breastfeeding.
Gynazol does not affect the ability to drive or operate machines.
Propylene glycol may cause skin irritation.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible late-type reactions).
This medicine should always be used exactly as advised by the doctor. In case of doubts, consult a doctor or pharmacist.
Gynazol is intended for vaginal use only. The medicine is in a single-dose applicator containing one dose of the medicine.
The entire contents of the applicator should be administered vaginally at one time (see below - Step 3).
The recommended dose is approximately 100 mg of butoconazole nitrate (5 g of cream contained in one applicator). The medicine should be used vaginally once, regardless of the time of day (preferably in the evening).
Step 1 -Preparing the applicator
Plunger with ring Tip
Fig. 1 Applicator
Step 2 -Inserting the applicator
Fig. 2
Fig. 3
Fig. 4
In case of accidental ingestion of Gynazol, consult a doctor or pharmacist as soon as possible, as gastric lavage may be necessary.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.
Like all medicines, Gynazol can cause side effects, although not everybody gets them.
The following side effects may occur: burning sensation, itching, pain, and swelling in the vulva or vagina, pain and/or cramps in the lower abdomen. Two or more of these symptoms may occur at the same time.
Local side effects of Gynazol are very similar to the clinical symptoms of vaginal yeast infection or vulvovaginitis. If these symptoms do not disappear during treatment, consult a doctor as soon as possible.
Allergic reactions (hypersensitivity reactions) may occur after using any medicine. Therefore, inform the doctor immediately if any of the following symptoms of allergy occur after using Gynazol: exfoliative dermatitis (redness or peeling), skin or mucous membrane changes, or hives.
If any side effects occur, including those not listed in this leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.
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 month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Each filled applicator contains 5 g of vaginal cream, including 100 mg of butoconazole nitrate.
A homogeneous, gentle cream, white or almost white in color.
Gynazol cream is placed in a polypropylene applicator. Each filled applicator is on a polystyrene tray placed in a laminated bag.
The bag is packed in a cardboard box.
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
To obtain more detailed information, contact the representative of the marketing authorization holder:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: +48 22 755 96 48
lekalert@grodzisk.rgnet.org
fax: +48 22 755 96 24
Date of last revision of the leaflet:
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