Miconal

Package Leaflet: Information for the Patient

MICONAL, 20 mg/g, Gel

Miconazole

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

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Miconal and what is it used for
• 2. Important information before using Miconal
• 3. How to use Miconal
• 4. Possible side effects
• 5. How to store Miconal
• 6. Contents of the pack and other information

1. What is Miconal and what is it used for

Miconal in the form of a gel contains the active substance miconazole. It is an antifungal medicine intended for topical use on the skin.

Indications for Use

Miconazole is used topically:

• for fungal infections of the skin and nails;
• for fungal infections secondarily infected by bacteria.

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).

Warnings and Precautions

• If the patient has ever had an allergy to miconazole or another antifungal medicine, they should consult a doctor before using the medicine.
• Miconal gel is intended for topical use on the skin only.
• If skin irritation or skin changes occur after using Miconal, the patient should stop using the medicine and consult a doctor.
• The patient should protect their eyes from contact with the medicine. If the gel gets into the eyes, they should be rinsed thoroughly with warm water.
• Miconal should not be used on mucous membranes or damaged skin.

Miconal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Patient taking oral anticoagulants (e.g., warfarin) should be cautious.
The effects and side effects of some other medicines (e.g., oral antidiabetic medicines and phenytoin) may be intensified when used concurrently with Miconal.

Pregnancy and breastfeeding

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.
Miconal should be avoided during pregnancy unless the doctor considers it necessary.
The use of Miconal gel in breastfeeding women should be decided by a doctor.

Driving and using machines

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

Miconal contains propylene glycol

The medicine contains 200 mg of propylene glycol in each gram of gel.
Propylene glycol may cause skin irritation.
This medicine should not be used in children under 4 weeks of age on open wounds or large areas of damaged or broken skin (e.g., burned skin) without consulting a doctor or pharmacist.

Miconal contains benzyl alcohol

The medicine contains 100 mg of benzyl alcohol in each gram of gel.
Benzyl alcohol may cause allergic reactions or mild local irritation.

Miconal contains ethanol

This medicine contains 410 mg of alcohol (ethanol) in each gram of gel.
The medicine may cause burning of damaged skin.
In newborns (premature and full-term infants), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusive dressings).

Miconal contains dimethyl sulfoxide

This medicine contains 50 mg of dimethyl sulfoxide in each gram of gel.
The medicine may cause skin irritation.

3. How to use Miconal

The medicine is intended for topical use on the skin.
Recommended dose
Unless the doctor has prescribed otherwise, a thin layer of gel (about 1 mm) should be applied to the affected skin area twice a day (morning and evening). On the affected nail surface, the gel should be applied once or twice a day.
After each application of the gel, the hands should be washed thoroughly with soap and water.
Treatment duration
The treatment duration is usually 2 to 6 weeks, depending on the location and severity of the changes.
After all symptoms and changes have disappeared, treatment should be continued for at least 1 more week.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

Using more than the recommended dose of Miconal

Using the medicine too frequently may cause skin irritation, which usually disappears after stopping the use of the medicine.
In case of accidental ingestion of the medicine, the patient should contact a doctor immediately.
Miconal is intended for use on the skin only, not for oral use. In case of accidental swallowing of the medicine, the doctor may recommend the use of an appropriate method of stomach emptying.

Missing a dose of Miconal

If a dose is missed at the usual time, the medicine should be used as soon as possible, and then regular use of the medicine should be continued.
Do not use a double dose 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 gel occur very rarely (less often than in 1 in 10,000 patients). These include:

• wheezing, swelling of the face, lips, tongue, or throat, rash, fainting, or difficulty swallowing (severe allergic reaction). If any of these reactions occur, the medicine should be stopped immediately, and a doctor should be consulted.
• hives, contact dermatitis, rash, redness, itching, burning sensation on the skin, reactions at the site of application of the gel, including irritation. If any side effects occur, including any possible side effects not listed in the leaflet, the patient should consult a doctor or pharmacist.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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
Website: https://smz.ezdrowie.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 the medicine.

5. How to store Miconal

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store the tube tightly closed to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging .
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Miconal contains

The active substance of the medicine is miconazole.
1 g of gel contains 20 mg of miconazole.
Other ingredients of the medicine are: dimethyl sulfoxide, benzyl alcohol, isopropyl alcohol, propylene glycol, hydroxypropyl cellulose, ethanol 96%.

What Miconal looks like and contents of the pack

Colorless, transparent, or slightly opalescent gel.
Packaging:30 g in a tube.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
For more detailed information, please contact the marketing authorization holder.

Date of last revision of the leaflet: