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 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.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, talk to a doctor or pharmacist.
• If you get any side effects, talk to a doctor, pharmacist, or nurse. See section 4.
• If you do not feel better or if you feel worse, you should contact a 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 you are 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, discuss it with your doctor or pharmacist. If you experience any signs of an allergic reaction or skin irritation, stop the treatment and contact a doctor. Avoid contact between Daktarin cream and the eyes.

Daktarin Cream and Other Medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. In patients taking oral anticoagulants, such as warfarin, it is necessary to monitor the anticoagulant effect. The effect and side effects associated with the use of some 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 you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. The doctor will weigh the potential risk associated with the use of the medicine against the expected therapeutic benefits. It is not known whether the active substance of the medicine, miconazole, passes into breast milk. Therefore, Daktarin cream can be used in breast-feeding women only on the advice of a doctor.

Driving and Using Machines

No effect of the medicine on the ability to drive or use machines has been observed.

Daktarin Cream Contains 2 mg of Benzonic Acid in Each g of Cream

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

Daktarin Cream Contains Butylhydroxyanisole

The medicine may cause a local skin reaction (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 you are unsure, talk to a 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 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 changes. After the disappearance of all symptoms and changes, the treatment should be continued for at least 1 week. If you feel that the effect of the medicine is too strong or too weak, you should talk to a 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. You should contact a doctor immediately in case of accidental ingestion of the medicine. Daktarin cream is intended for use on the skin only, not for oral use.

Missing a Dose of Daktarin Cream

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

Stopping the Use of Daktarin Cream

If you have any further doubts about the use of this medicine, you should talk to a 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 (occur in less than 1 in 10,000 patients). After the medicine was placed on the market, very rare cases of allergic reactions, including severe ones, such as anaphylactic reactions and angioedema, urticaria, contact dermatitis, rash, erythema, itching, skin inflammation, skin discoloration, burning sensation on the skin, and local irritation, including irritation, burning, itching, and a feeling of warmth at the application site of Daktarin cream, have been reported.

Reporting Side Effects

If you experience any side effects, including those not listed in the leaflet, you should tell your 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to Store Daktarin Cream

Do not store above 25°C. Keep the medicine out of the 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. Ask your pharmacist 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, benzonic acid, 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, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Ireland, the Country of Export:

JNTL Consumer Health I (Ireland) Ltd., Block 5, High Street, Tallaght, Dublin 24, D24 YK8N, Ireland

Manufacturer:

Janssen Pharmaceutica NV, Turnhoutseweg 30, B2340, Beerse, Belgium

Parallel Importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Ireland export authorization number: PA23490/028/001

Parallel Import Authorization Number: 50/25

Date of Approval of the Leaflet: 04.02.2025

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