Package leaflet: Information for the patient

Miconal, 3.29 mg/g, cutaneous spray, suspension
Miconazole nitrate
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor, pharmacist, or nurse.

Keep this leaflet so that it can be read again if necessary.
If advice or further information is needed, consult a pharmacist.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If symptoms do not improve or worsen, contact a doctor.

Table of contents

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

1. What Miconal is and what it is used for

Miconal in the form of a spray contains the active substance miconazole. It is an antifungal medicine intended for topical use.
Indications
Miconazole is used topically:

in fungal infections of the skin (tinea of the scalp, trunk, hands, feet and between the toes, armpits, groin);
in mixed fungal-bacterial infections.

2. Important information before using Miconal

When not to use Miconal
If the patient is allergic to miconazole or any of the other ingredients of this medicine (listed in section 6).
This medicine should not be used to treat fungal infections of the scalp, nails, mucous membranes, or on broken or damaged skin.

Warnings and precautions
Before starting treatment with Miconal, discuss it with your doctor or pharmacist.

If the patient has ever had an allergic reaction to miconazole or any other antifungal medicine in the past, consult a doctor before using this medicine.
Miconal in aerosol form is intended for topical use on the skin only.
If skin irritation or skin changes occur after applying Miconal, discontinue use and contact your doctor.
Protect the eyes from the sprayed substance. If the suspension gets into the eyes, rinse thoroughly with lukewarm water.
Do not inhale the sprayed substance.
If the patient is taking oral anticoagulant medicines such as warfarin, discontinue using Miconal 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 Miconal. During treatment with Miconal, the international normalized ratio (INR) values should be closely monitored under the supervision of a healthcare professional.

Miconal and other medicines
Inform your doctor, pharmacist, or dentist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Patients taking oral anticoagulant medicines (e.g. warfarin) must exercise caution.
Miconal may affect the action of oral anticoagulant medicines (blood-thinning medicines), such as warfarin.
The effects and adverse reactions of certain other medicines (e.g. oral antidiabetic medicines and phenytoin – an anticonvulsant and antiarrhythmic medicine) may be intensified when used concomitantly with Miconal.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

If the patient is pregnant or suspects she may be pregnant
Avoid using Miconal during pregnancy unless the doctor considers its use necessary.

If the patient is breastfeeding
The decision to use Miconal aerosol in breastfeeding women should be made by a doctor.

Effect on fertility
No data available.

Driving and operating machinery
No data available on the effect of the medicine on the ability to drive or operate machinery.

3. How to use Miconal medicine

For topical use on the skin.
Unless otherwise directed by a physician, the medicine should be applied locally to the affected area of skin twice daily (morning and evening).
Shake the container vigorously before each use.
Duration of treatment
After all symptoms and skin lesions have resolved, treatment should still be continued for at least 1 week.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Miconal medicine
Excessive use of the medicine may cause skin irritation, which usually resolves after discontinuation of the medicine.
In case of accidental ingestion, contact a doctor immediately.
Miconal medicine is intended for topical use on the skin only, not for oral administration.
In case of accidental ingestion, a doctor may recommend appropriate gastric evacuation procedures.
If a dose of Miconal medicine is missed
If a dose is missed at the usual scheduled time, apply the medicine as soon as possible, then continue with regular dosing.
Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, Miconal may cause adverse effects, although not everyone experiences them.
Adverse effects after using Miconal aerosol are very rare (occurring in less than 1 in 10,000 people).
These include:

sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction); if any of these symptoms occur, the medicine must be stopped immediately and a doctor contacted;
urticaria, contact dermatitis, rash, erythema, itching, burning sensation on the skin, skin irritation at the site of aerosol 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.
Adverse effects can also be reported to the marketing authorization holder.

5. How to store Miconal

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the stated month.

Extremely flammable aerosol
Pressurized container. Heating may cause an explosion.
Keep away from heat/sparks, open flames, and hot surfaces. No smoking.
Do not spray on an open flame or other ignition source.
Pressurized container. Do not pierce or burn, even after use.
Protect from sunlight. Do not expose to temperatures exceeding 50°C / 122°F.

Medicines must 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 package and other information

What Miconal contains
The active substance is miconazole in the form of miconazole nitrate.
1 g of the suspension contains 3.29 mg of miconazole nitrate.
The other ingredients are: sorbitan trioleate (Span 85), lecithin, isopropyl myristate,
Drivosol 35 A (a mixture of propane, butane, isobutane).

What Miconal looks like and contents of the pack
Miconal is a homogeneous white-cream coloured suspension.
Pack: a container with 39.5 g of suspension in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
Al. A. Fleminga 2
03-176 Warsaw
Tel.: 22 811-18-14
For further information, please contact the Marketing Authorisation Holder.