PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Daktarin
20 mg/g, cream
Miconazoli nitras
Please read carefully the entire leaflet 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
your doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, please consult your doctor or pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of contents

What Daktarin cream is and what it is used for
Important information before using Daktarin cream
How to use Daktarin cream
Possible side effects
How to store Daktarin cream
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 activity against dermatophytes and yeasts, as well as antibacterial activity against Gram-positive bacilli and cocci. Miconazole is also used in the treatment of secondarily infected fungal infections.
Miconazole usually relieves skin itching, which often accompanies infections caused by dermatophytes and yeasts. Itching subsides before other signs of healing appear.
Indications
Daktarin cream is indicated for the treatment of fungal skin infections caused by dermatophytes, yeasts, and other fungi, such as: tinea capitis, tinea corporis, tinea manuum, tinea cruris, and interdigital tinea pedis (athlete's foot).
Due to its antibacterial action, Daktarin cream may also be used in fungal infections secondarily infected by bacteria (e.g. diaper dermatitis).

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 scalp, mucous membranes, nails, or on broken skin.

Warnings and precautions
Before starting treatment with DAKTARIN Cream, discuss this with your doctor or pharmacist.
If symptoms of allergy or skin irritation occur, treatment should be discontinued and the patient should contact a doctor.
Avoid contact of DAKTARIN Cream with the eyes.

DAKTARIN Cream and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines the patient intends to take.
In patients taking oral anticoagulants such as warfarin, monitoring of anticoagulant effect is necessary. The effects and adverse reactions associated with the use of certain other medicines (e.g. oral antidiabetic drugs and phenytoin) may be intensified when used concomitantly with DAKTARIN Cream.
Caution is advised when using other medicines simultaneously.

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.
The doctor will assess the potential risk associated with using the medicine against the expected therapeutic benefits. It has not been established 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 operating machinery
No influence of the medicine on the ability to drive or operate machinery has been observed.

DAKTARIN Cream contains 2 mg of benzoic acid per g of cream
Benzoic acid may cause local irritation. Benzoic 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
This medicine may cause a local skin reaction (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. HOW TO USE DAKTARIN CREAM

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

Dosage
Daktarin cream should be applied to the affected areas of skin, usually twice daily.
If Daktarin cream is used at the same time as Daktarin medicated powder, it is recommended to use both forms once daily.
The duration of treatment ranges from 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 additional week.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Use of more than the recommended dose of Daktarin cream
Excessive use of the medicine may cause skin irritation, which usually resolves after discontinuation of the product.
Seek immediate medical advice in case of accidental ingestion.
Daktarin cream is for external use only and must not be taken orally.

Missed dose of Daktarin cream
Do not apply a double dose to make up for a missed dose.

Stopping Daktarin cream
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Daktarin cream may cause adverse reactions, although not everyone will experience them.
The frequency of the possible adverse reactions listed below is defined as follows: very rare (occurring in fewer than 1 in 10,000 patients).

Post-marketing experience has very rarely reported: hypersensitivity reactions, including severe reactions such as anaphylactic reactions and angioedema, urticaria, contact dermatitis, rash, erythema, pruritus, dermatitis, depigmented skin patches, burning sensation on the skin, local reactions at the application site including irritation, burning, itching, and sensation of warmth at the site of application of Daktarin cream.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE DAKTARIN CREAM

Do not store above 25°C.
Keep in a place out of sight and reach of children.
Do not use Daktarin cream after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Daktarin cream contains

The active substance is miconazole nitrate. 1 g of cream contains 20 mg of miconazole nitrate.
Other ingredients are macrogol 6 stearate, macrogol glyceryl monooleate, liquid paraffin, butylhydroxyanisole, benzoic acid, purified water.

What Daktarin cream looks like and contents of the pack
The medicinal product is packed in a tube containing 30 g of cream, placed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, the country of export:
Johnson & Johnson Hellas Consumer AE
Aigialeias & Epidavrou 4
15125 Marousi
Greece
Manufacturer:
Janssen Pharmaceutica NV
Turnhoutseweg 30
2340 Beerse
Belgium
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Greece, the country of export: 6792/12-02-2015
8533/6-2-2007
Parallel Import licence number: 411/19