Daktarin

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Daktarin, 20 mg/g (2%), Cream

Miconazole Nitrate

Read the Leaflet Carefully Before Using the Medicinal Product, as it Contains

Important Information for the Patient.
This medicinal product should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or further information is needed, a doctor or pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this 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 consulted.

Table of Contents of the Leaflet:

• 1. What Daktarin Cream is and What it is 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 Daktarin Cream is and What it is Used For

Daktarin Cream contains the active substance miconazole. Miconazole has antifungal effects, including on dermatophytes and yeasts, and antibacterial effects on Gram-positive bacilli 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 the antibacterial effect of Daktarin Cream, it 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 medicinal product (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 doctor or pharmacist should be consulted.
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 doctor should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 hypoglycemic agents and phenytoin) may be intensified when used concomitantly with Daktarin Cream.
Caution should be exercised when using other medicines concomitantly.

Pregnancy and Breast-feeding

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

Driving and Using Machines

No effects of the medicinal product 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 medicinal product may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to Use Daktarin Cream

This medicinal product should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

Dosage

Daktarin Cream is applied to the affected areas of the skin, usually twice a day.
If Daktarin Cream is used concomitantly with Daktarin Medicinal 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 the disappearance of all symptoms and lesions, treatment should be continued for at least 1 week.
If the patient feels that the effect of the medicinal product is too strong or too weak, a doctor should be consulted.

Using More than the Recommended Dose of Daktarin Cream

Too frequent use of the medicinal product may cause skin irritation, which usually disappears after discontinuation of the medicinal product.
A doctor should be consulted immediately in case of accidental ingestion of the medicinal product.
Daktarin Cream is intended for use on the skin only, not for oral use.

Missing a Dose of Daktarin Cream

A double dose should not be used to make up for a missed dose.

Stopping Use of Daktarin Cream

In case of further doubts about the use of this medicinal product, a doctor or pharmacist should be consulted.

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 (occurring in less than 1 in 10,000 patients).
Very rare side effects that have been reported after the medicinal product has been on the market include: hypersensitivity reactions, including severe reactions such as anaphylaxis and angioedema, urticaria, contact dermatitis, rash, erythema, pruritus, skin inflammation, skin discoloration, burning sensation on the skin, local reactions at the application site, including irritation, burning, itching, and warmth at the application site of Daktarin Cream.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects will help to gather more information on the safety of this medicinal product.

5. How to Store Daktarin Cream

Do not store above 25°C.
The medicinal product should be kept out of the 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.
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. 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 contains a tube with 30 g of cream, placed in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing Authorization Holder in Greece, the Country of Export:

Johnson & Johnson Hellas Consumer AE
Aigialeias & Epidavrou 4
Marousi
15125 Athens
Greece

Manufacturer:

Janssen Pharmaceutica NV
Turnhoutseweg 30
2340 Beerse
Belgium

Parallel Importer:

InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Greece, the Country of Export:8533/06-02-2007
1353/15-01-1996
6792/12-02-2015
Parallel Import Authorization Number:140/09

Date of Approval of the Leaflet: 01.07.2024

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