Daktarin

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

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

Daktarin

20 mg/g, cream

Miconazole nitrate

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

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

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 bacilli and cocci.
Miconazole is also used to treat fungal infections that are secondarily infected.
Miconazole usually relieves 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.
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 doctor or pharmacist should be consulted.
If symptoms of an allergic reaction or skin irritation occur, treatment should be stopped and the doctor
contacted.
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 anticoagulant medicines, such as warfarin, monitoring of anticoagulant activity is
required. The effects and side effects of certain other medicines (e.g., oral medicines that lower blood sugar
levels and phenytoin) may be intensified when used concurrently with Daktarin cream.
Caution should be exercised when using other medicines.

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 of the medicine on driving or using machines have been observed.

Daktarin cream contains 2 mg of benzoic acid per gram 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

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 the
doctor or pharmacist. In case of doubt, the 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 at the same time as Daktarin medicated powder, it is recommended to use both
forms of the medicine 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
medicine.
The doctor should be contacted immediately 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

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

Stopping treatment with Daktarin cream

In case of further doubts about using this medicine, the 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 medicine was placed on the market include: allergic
reactions, including severe reactions such as anaphylaxis and angioedema, hives, contact dermatitis, rash,
redness, itching, skin inflammation, light spots on the skin, 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 any side effects not listed in the 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 of the 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 the medicine.

5. HOW TO STORE DAKTARIN CREAM

Do not store above 25°C.
Keep 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 month stated.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how
to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Daktarin cream contains

• The active substance of the medicine is miconazole nitrate. 1 g of cream contains 20 mg of miconazole
  nitrate.
• Other ingredients are macrogol 6 and macrogol 32 glycerol stearate, macrogol glycerides, liquid paraffin,
  butylhydroxyanisole, benzoic acid, purified water.

What Daktarin cream looks like and what the pack contains

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
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 by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Greece, the country of export: 6792/12-02-2015
8533/6-2-2007
Parallel import authorization number: 411/19

Date of leaflet approval: 24.10.2024

[Information about the trademark]