Package leaflet: Information for the patient

MICONAL, 20 mg/g, gel
Miconazolum
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 or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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 gel contains the active substance miconazole. It is an antifungal medicine intended for topical application to the skin.
Indications
Miconazole is used topically:

in fungal infections of the skin and nails;
in 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 allergic reaction to miconazole or another antifungal medicine in the past, consult a doctor before using this medicine.
Miconal gel is intended for topical use on the skin only.
If skin irritation or skin changes occur after applying Miconal, discontinue use and contact a doctor.
Avoid contact with the eyes. If the gel gets into the eyes, rinse thoroughly with lukewarm water.
Do not apply Miconal to mucous membranes or broken skin.
If the patient is taking oral anticoagulant medicines such as warfarin, discontinue use of Miconal immediately and consult a doctor or pharmacist if unexpected bleeding or bruising occurs during treatment with Miconal, such as nosebleeds, coughing up blood, blood in urine, black tarry stools, or coffee-ground vomit.
During treatment with Miconal, the international normalized ratio (INR) should be closely monitored under the supervision of a healthcare professional.

Miconal and other medicines
Inform your doctor, pharmacist, or dentist about all medicines currently used, recently used, or planned to be used.

Patients taking oral anticoagulant medicines (e.g. warfarin) should exercise caution. Miconal may affect the action of oral anticoagulants (blood thinners), such as warfarin.

The effects and adverse reactions of certain other medicines (e.g. oral antidiabetic drugs and phenytoin) may be intensified when used concomitantly with Miconal.

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.

Avoid using Miconal during pregnancy unless the doctor considers its use necessary.

The decision on using Miconal gel in breastfeeding women should be made by a doctor.

Driving and operating machinery
There is no data available on the influence of this medicine on the ability to drive or operate machinery.

Miconal contains propylene glycol
This medicine contains 200 mg of propylene glycol in each gram of gel.
Propylene glycol may cause skin irritation.
Do not use this medicine in children under 4 weeks of age on open wounds or large areas of injured or damaged skin (e.g. burned skin) without consulting a doctor or pharmacist.

Miconal contains benzyl alcohol
This 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 a stinging sensation on damaged skin.
In neonates (preterm and full-term newborns), high concentrations of ethanol may lead to 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 application to the skin.
Recommended dose
Unless otherwise advised by your doctor, apply a thin layer of gel (approximately 1 mm) to the affected skin area twice daily (morning and evening). For affected nail areas, apply the gel once or twice daily.
After each application, hands should be thoroughly washed with soap and water.
Duration of treatment
The treatment duration is usually 2 to 6 weeks, depending on the location and severity of the lesions.
After all symptoms and skin lesions have resolved, treatment should be continued for at least 1 more week.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Miconal
Excessive use of the medicine may cause skin irritation, which usually resolves after discontinuation of the medicine.
Contact your doctor immediately if the medicine is accidentally ingested.
Miconal is intended for topical use on the skin only, not for oral administration. In case of accidental ingestion, the doctor may recommend appropriate methods for gastric evacuation.
Missed dose of Miconal
If you miss a dose at the usual scheduled time, apply the medicine as soon as possible, then continue regular use.
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, Miconal may cause adverse reactions, although not everyone experiences them.
Adverse reactions following the use of Miconal gel are very rare (occurring in fewer than 1 in 10,000 patients). These include:

sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction). If any of the above reactions occur, the medicine must be discontinued immediately and a doctor should be contacted without delay.
urticaria, contact dermatitis, rash, erythema, itching, burning sensation on the skin, local reactions at the site of gel application including irritation. If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, medical advice should be sought from a doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to enhance the safety information available regarding the use of this medicine.

5. How to store Miconal
Keep the medicine out of sight and reach of children.
Store below 25°C. Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Miconal contains
The active substance is miconazole.
1 g of gel contains 20 mg of miconazole.
Other ingredients are: dimethyl sulfoxide, benzyl alcohol, isopropyl alcohol, propylene glycol, hydroxypropyl cellulose, ethanol 96%.
What Miconal looks like and contents of the pack
Colourless, transparent or slightly opalescent gel.
Pack: 30 g in a tube.
Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
For further information, please contact the Marketing Authorisation Holder.