Miconal

Package Leaflet: Information for the Patient

Miconal, 3.29 mg/g, skin spray, suspension
Miconazole nitrate

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be contacted.

Package Leaflet Contents

• 1. What Miconal is and what it is used for
• 2. Important information before using Miconal
• 3. How to use Miconal
• 4. Possible side effects
• 5. How to store Miconal
• 6. Package contents 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 for topical use.

Indications for use

Miconazole is used topically:

• in fungal skin infections (ringworm of the head, trunk, hands, feet, and between the fingers, 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). The medicine should not be used to treat fungal infections of the hairy scalp, nails, mucous membranes, or damaged skin.

Warnings and precautions

Before starting to use Miconal, the doctor or pharmacist should be consulted.

• If the patient has ever had an allergy to miconazole or another antifungal medicine, the doctor should be consulted before using the medicine.
• Miconal in the form of a spray is intended only for topical use on the skin.
• If skin irritation or skin changes occur after using Miconal, the use of the medicine should be stopped and a doctor consulted.
• The eyes should be protected from the sprayed substance. If the suspension gets into the eyes, they should be rinsed thoroughly with lukewarm water.
• The sprayed substance should not be inhaled.

Miconal and other medicines

The doctor or pharmacist should be told about all medicines being taken currently or recently, as well as any medicines the patient plans to use.
Patients taking oral anticoagulant medicines (e.g., warfarin) should be cautious.
The effects and side effects of certain other medicines (e.g., oral antidiabetic medicines and phenytoin – a medicine with antiepileptic and antiarrhythmic effects) may be enhanced when used with Miconal.

Pregnancy, breastfeeding, and fertility

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.
If the patient is pregnant or thinks they may be pregnant
Miconal should be avoided during pregnancy unless the doctor considers the use of the medicine necessary.
If the patient is breastfeeding
The use of Miconal spray in breastfeeding women should be decided by a doctor.
Effects on fertility
There are no data available.

Driving and using machines

There are no data available on the effects of the medicine on the ability to drive and use machines.

3. How to use Miconal

For skin use only.
Unless the doctor has prescribed otherwise, the medicine should be used topically on the affected skin surface twice a day (morning and evening).
Shake the container vigorously before each use.

Treatment duration

After all symptoms and changes have disappeared, treatment should be continued for at least another week.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor.

Using more Miconal than prescribed

Using the medicine too frequently may cause skin irritation, which usually disappears after stopping the use of the medicine.
A doctor should be contacted immediately in case of accidental ingestion of the medicine.
Miconal is intended for use on the skin only, not for oral use.
In case of accidental ingestion of the medicine, the doctor may recommend the use of an appropriate method to empty the stomach.

Missing a dose of Miconal

If a dose of the medicine is missed at the usual time, it should be used as soon as possible, and then the regular use of the medicine should be continued.
A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medicines, Miconal can cause side effects, although not everybody gets them.
Side effects after using Miconal spray occur very rarely (in less than 1 in 10,000 people).
These include

• sudden wheezing, swelling of the face, lips, tongue, or throat, rash, fainting, or difficulty swallowing (severe allergic reaction); if such symptoms occur, the medicine should be stopped immediately and a doctor consulted;
• hives, contact dermatitis, rash, redness, itching, burning sensation on the skin, skin irritation at the application site.

Reporting side effects

If any side effects occur, including any not listed in the package leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, e-mail: ndl@urpl.gov.pl.
Reporting side effects will help to gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. Storing Miconal

The medicine should be kept out of the sight and reach of children.
Store at a temperature 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 month stated.

• Highly flammable aerosol
• Pressurized container. Heating may cause a burst.
• Keep away from heat sources/ignition sources, open flames/hot surfaces. No smoking.
• Do not spray near open flames or other ignition sources.
• Pressurized container. Do not pierce or burn, even after use.
• Protect from sunlight. Do not expose to temperatures above 50°C / 122°F.

Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information What Miconal contains

The active substance of the medicine is miconazole in the form of miconazole nitrate.
1 g of suspension contains 3.29 mg of miconazole nitrate.
Other ingredients of the medicine 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 suspension of white-beige color.
Packaging:a container containing 39.5 g of suspension in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna ul.

• A. Fleminga 2 03-176 Warszawa Phone number: 22 811-18-14

For more detailed information, the marketing authorization holder should be contacted.

Date of last revision of the package leaflet: