Daktarin

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Daktarin(Daktarin 2%-Cream)

20 mg/g (2%), cream

Miconazole nitrate
Daktarin and Daktarin 2%-Cream are different trade names for the same medicine.

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

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

Table of Contents of the Leaflet

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

1. What is Daktarin cream and what is it used for

Daktarin cream contains the active substance miconazole. Miconazole has antifungal effects, including on dermatophytes and yeasts, as well as antibacterial effects on Gram-positive rods and cocci.
Miconazole is also used to treat fungal infections that are secondarily infected.
Miconazole usually eliminates skin itching, which often accompanies infections caused by dermatophytes and yeasts. The itching disappears before other signs of healing appear.

Indications for Use

Daktarin cream is indicated for the treatment of fungal skin infections caused by dermatophytes, yeasts, and other fungi, such as: scalp ringworm, body ringworm, hand ringworm, and athlete's foot (tinea pedis).
Due to its antibacterial effect, Daktarin cream may be used in fungal infections secondarily infected by bacteria (e.g., diaper rash).

2. Important Information Before Using Daktarin Cream

When Not to Use Daktarin Cream:

• if the patient is allergic to miconazole, other similar antifungal medicines, or any of the other ingredients of this medicine (listed in section 6),
• for the treatment of fungal infections of the hairy scalp, mucous membranes, nails, or damaged skin.

Warnings and Precautions

Before starting to use Daktarin cream, the patient should discuss it with their doctor or pharmacist.
If symptoms of an allergic reaction or skin irritation occur, treatment should be discontinued and a doctor consulted.
Contact between Daktarin cream and the eyes should be avoided.

Daktarin Cream and Other Medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In patients taking oral anticoagulants, such as warfarin, monitoring of anticoagulant activity is necessary. The effects and side effects of certain other medicines (e.g., oral blood sugar-lowering medicines and phenytoin) may be enhanced when used concomitantly with Daktarin cream.
Caution should be exercised when using other medicines concomitantly.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The doctor will weigh the potential risks and benefits of using the medicine. It is not known whether the active substance of the medicine, miconazole, passes into breast milk. Therefore, Daktarin cream should only be used in breastfeeding women on the advice of a doctor.

Driving and Using Machines

No effects on the ability to drive or use machines have been observed.

Daktarin Cream Contains 2 mg of Benzonic Acid per g of Cream

Benzonic acid may cause local irritation. Benzonic acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

Daktarin Cream Contains Butylhydroxyanisole

The medicine may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to Use Daktarin Cream

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Dosage

Daktarin cream is applied to the affected areas of the skin, usually twice a day.
If Daktarin cream is used concomitantly with Daktarin medicated powder, it is recommended to use both formulations once a day.
The duration of treatment is from 2 to 6 weeks, depending on the location and severity of the lesions.
After all symptoms and lesions have disappeared, treatment should be continued for at least 1 week.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using More Than the Recommended Dose of Daktarin Cream

Using the medicine too frequently may cause skin irritation, which usually disappears after stopping the use of the medicine.
The patient should immediately consult their doctor in case of accidental ingestion of the medicine.
Daktarin cream is for external use only and should not be taken orally.

Missing a Dose of Daktarin Cream

The patient should not use a double dose to make up for a missed dose.

Stopping Treatment with Daktarin Cream

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Daktarin cream can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as follows:
very rare (occurs in less than 1 in 10,000 patients).
Very rarely, the following have been reported after the medicine was placed on the market: hypersensitivity reactions, including severe reactions such as anaphylaxis and angioedema, hives, contact dermatitis, rash, redness, itching, skin inflammation, pale spots on the skin, burning sensation on the skin, disorders at the application site, including irritation, burning, itching, and warmth at the application site of Daktarin cream.

Reporting Side Effects

If the patient experiences any side effects, including any not listed in the leaflet, they 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
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Daktarin Cream

Do not store above 25°C.
The medicine should be kept out of sight and reach of children.
Daktarin cream should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The shelf-life after first opening: 3 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the Pack and Other Information

What Daktarin Cream Contains

• The active substance is miconazole nitrate. 1 g of cream contains 20 mg of miconazole nitrate.
• The other ingredients are butylhydroxyanisole (E 320), benzonic acid (E 210), liquid paraffin, macrogol glycerol oleate, macrogol 6 and macrogol 32 glycerol stearate, purified water.

What Daktarin Cream Looks Like and Contents of the Pack

The pack consists of an aluminum tube with an internal coating and a polypropylene screw cap, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Austria, the Country of Export:

Johnson & Johnson GmbH
Leopold Ungar Platz 2
1190 Vienna
Austria

Manufacturer:

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
2340 Beerse
Belgium

Parallel Importer:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing authorization number in Austria, the country of export: 15.307

Parallel Import Authorization Number: 111/25

Date of Approval of the Leaflet: 26.03.2025

[Information about the trademark]