Gino-femidazol

Package Leaflet: Information for the Patient

Gyno-Femidazol, 100 mg, Vaginal Tablets

Miconazole Nitrate

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

What is Gyno-Femidazol and what is it used for
Important Information Before Using Gyno-Femidazol
How to Use Gyno-Femidazol
Possible Side Effects
How to Store Gyno-Femidazol
Contents of the Package and Other Information

1. What is Gyno-Femidazol and What is it Used For

Gyno-Femidazol is used exclusively vaginally. The medication only works at the site of administration.
Miconazole nitrate, the active substance of Gyno-Femidazol, destroys the cells of pathogenic fungi and combats fungal infections of the vagina.

Gyno-Femidazol is Used to Treat the Following Diseases:

Fungal and yeast infections of the vagina

2. Important Information Before Using Gyno-Femidazol

When Not to Use Gyno-Femidazol

If the patient is allergic to miconazole nitrate, other similar antifungal medications, or any of the other components of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur, consult a doctor).

Warnings and Precautions

Using Gyno-Femidazol does not require special precautions, however, in the case of local irritation or an allergic reaction, treatment should be discontinued.
Protect your eyes from contact with the medication.
Do not use in children and adolescents under 18 years of age.
Gyno-Femidazol should not be used simultaneously with a latex condom or latex diaphragm.
This is because Gyno-Femidazol may damage latex products and prevent them from working properly.
Consult a doctor even if the above warnings apply to past situations.

Gyno-Femidazol and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking, or have recently taken, as well as any medications you plan to take.
Gyno-Femidazol weakens the effect of certain antibiotics (nystatin, natamycin). Do not use Gyno-Femidazol in combination with certain antibiotics.
Be cautious when using Gyno-Femidazol with oral anticoagulant medications (acenocoumarol, warfarin) due to the possible increased risk of blood coagulation disorders and bleeding. Due to the very low absorption of the medication from the vagina into the blood, this risk is unlikely. Nevertheless, patients treated simultaneously with oral anticoagulant medications and Gyno-Femidazol should have their blood coagulation time controlled frequently.
Avoid contact between intrauterine devices (such as an IUD) or latex condoms and Gyno-Femidazol, as one of the components of the medication may damage the latex.

Gyno-Femidazol with Food and Drink

The medication can be taken independently of meals. Food does not affect the efficacy of the medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medication.
It is not known whether the medication passes into breast milk. Breastfeeding women should exercise caution when using Gyno-Femidazol.

Driving and Operating Machinery

Gyno-Femidazol does not affect the ability to drive or operate machinery.

Gyno-Femidazol Contains Lactose and Glycerol

In the case of vaginal use, this is not significant for the patient.

3. How to Use Gyno-Femidazol

This medication should always be used as directed by your doctor. In case of doubts, consult a doctor or pharmacist.
Typically, the recommended dose is 1 tablet (100 mg) per day.
Gyno-Femidazol is used once a day, in the evening.

Use in Patients with Liver or Kidney Impairment

Dose adjustment is not necessary.

Use in Elderly Patients

Dose adjustment is not necessary.

Use in Children and Adolescents Under 18 Years of Age

Gyno-Femidazol is not recommended for use in children and adolescents under 18 years of age.
Gyno-Femidazol is intended for vaginal use only.
The tablet should be inserted deep into the vagina.
Treatment should last 15 days.
If you feel that the effect of Gyno-Femidazol is too strong or too weak, consult your doctor.

In Case of Accidental Oral Ingestion of the Medication, Consult a Doctor Immediately. Show the Doctor the Package with the Tablets.

Missing a Dose of Gyno-Femidazol

In case of missing a dose, use it as soon as possible, unless it is close to the time of the next dose. In this case, do not use the missed dose.
Do not use a double dose to make up for the missed dose.

Stopping the Use of Gyno-Femidazol

Do not stop treatment without consulting your doctor before completing the prescribed course, even if you feel better. Otherwise, the symptoms of the disease may recur.
In case of any further doubts about using this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Gyno-Femidazol can cause side effects, although not everybody gets them.
Gyno-Femidazol is a well-tolerated medication. Side effects, if they occur, are usually mild and transient.
No serious side effects have been reported in connection with the use of Gyno-Femidazol.
The following side effects may occur during treatment with Gyno-Femidazol:
irritation at the site of administration (burning, itching in the vulva area, sometimes spotting from the vagina),
local symptoms of allergy (rash on the skin),
hypersensitivity (see section 2; point: When Not to Use Gyno-Femidazol).
In case of hypersensitivity to Gyno-Femidazol, discontinue use.
The above side effects occur rarely (less than 1 in 1000 treated patients).

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, inform your 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
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Gyno-Femidazol

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the package. The expiration date refers to the last day of the specified month.
Do not store above 25°C.
Medications should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Package and Other Information

What Gyno-Femidazol Contains

The active substance of the medication is miconazole nitrate.
Other ingredients are: lactose monohydrate, potato starch, gelatin, glycerol, sodium carboxymethyl starch, magnesium stearate.

What Gyno-Femidazol Looks Like and What the Package Contains

Gyno-Femidazol is a white, oval-shaped tablet.
The package contains 15 tablets.

Responsible Entity and Manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
phone: (22) 755 50 81
To obtain more detailed information about the medication, contact:
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 Update of the Leaflet:September 2015
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