Package leaflet: Information for the patient

Gyno-Femidazol, 100 mg, vaginal tablets
Miconazoli nitras
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of contents

What Gyno-Femidazol is and what it is used for
Important information before using Gyno-Femidazol
How to use Gyno-Femidazol
Possible side effects
How to store Gyno-Femidazol
Contents of the pack and other information

1. What Gyno-Femidazol is and what it is used for

Gyno-Femidazol is intended for vaginal use only. The medicine acts locally at the site of administration.
Miconazole nitrate, the active substance in Gyno-Femidazol, destroys pathogenic fungal cells and treats vaginal fungal infections.
Gyno-Femidazol is used to treat the following conditions:
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 medicines, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may present as a rash, itching, swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur, contact a doctor immediately).

Warnings and precautions
No special precautions are required when using Gyno-Femidazol; however, if local irritation or an allergic reaction occurs, treatment should be discontinued.
Avoid contact of the medicine with the eyes.
Do not use in children and adolescents under 18 years of age.
If the patient is taking oral anticoagulants such as warfarin, discontinue use of Gyno-Femidazol immediately and consult a doctor or pharmacist if unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black tarry stools, or coffee-ground vomit occur during treatment with Gyno-Femidazol. During treatment with Gyno-Femidazol, international normalized ratio (INR) values should be closely monitored under the supervision of a healthcare professional.
Gyno-Femidazol should not be used simultaneously with latex condoms or latex diaphragms. This is because Gyno-Femidazol may damage latex products and impair their proper function.
Contact a doctor even if the above warnings relate to conditions that occurred in the past.

Gyno-Femidazol and other medicines
Inform your doctor, pharmacist, or dentist about all medicines currently or recently taken, as well as any medicines you plan to take.

Gyno-Femidazol reduces the effectiveness of certain antibiotics (nystatin, natamycin). Do not use Gyno-Femidazol concomitantly with these antibiotics.
Gyno-Femidazol may affect the action of oral anticoagulant drugs (blood thinners), such as warfarin. Exercise caution when using Gyno-Femidazol together with oral anticoagulants (acenocoumarol, warfarin) due to a possible increased risk of coagulation disorders and bleeding. Because absorption of the drug from the vagina into the bloodstream is very low, this risk is unlikely. Nevertheless, patients treated simultaneously with oral anticoagulants and Gyno-Femidazol should have their blood clotting time monitored appropriately and frequently.
Avoid contact between intrauterine contraceptive devices (so-called "coil") or latex condoms and Gyno-Femidazol, as one of the components of the medicine may damage latex.

Gyno-Femidazol with food and drink
This medicine may be used regardless of meals. Food does not affect the efficacy of the medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
It is not known whether the medicine 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
When used vaginally, this is not relevant for the patient.

3. How to use Gyno-Femidazol

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
The usual dose is 1 tablet (100 mg) per day.
Gyno-Femidazol should be used once daily, in the evening.
Use in patients with hepatic or renal 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 for 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, seek medical advice immediately. Show the doctor the medicine packaging.
Missed dose of Gyno-Femidazol
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. In that case,
the missed dose should be omitted.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Gyno-Femidazol
Do not discontinue treatment without consulting your doctor before completing the prescribed course, even
if you feel better. Otherwise, symptoms may recur.
If you have any further questions 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 everyone experiences them.
Gyno-Femidazol is a well-tolerated medicine. Adverse reactions, if they occur, are usually mild and transient.
No severe adverse reactions have been reported in connection with the use of Gyno-Femidazol.
The following adverse reactions may occur during treatment:

irritation at the site of administration (burning, itching in the vulvar area, sometimes vaginal spotting),
local allergic symptoms (skin rash),
hypersensitivity (see section 2; When not to use Gyno-Femidazol). In case of hypersensitivity, Gyno-Femidazol should be discontinued.

The above-mentioned adverse reactions occur rarely (less than 1 in 1,000 treated patients).
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Gyno-Femidazol

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 stated month.
Do not store above 25°C.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Gyno-Femidazol contains
The active substance is miconazole nitrate.
The other ingredients are: monohydrate lactose, potato starch, gelatin, glycerol, sodium carboxymethyl starch, magnesium stearate.

What Gyno-Femidazol looks like and contents of the pack
Gyno-Femidazol is in the form of white, oval tablets.
The pack contains 15 tablets.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
tel.: (22) 755 50 81

For further information about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]

((logo of the Marketing Authorisation Holder))
((pharmacode))