Daktarin

Package Leaflet: Information for the User

Daktarin, 20 mg/g, Cream

Miconazole Nitrate

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, you should contact your 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 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 the appearance of other signs of healing.

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, you should discuss it with your doctor or pharmacist.
If you experience any signs of an allergic reaction or skin irritation, you should stop the treatment and contact your doctor.
Avoid contact between Daktarin cream and the eyes.

Daktarin Cream and Other Medicines

You should 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 effects and side effects associated with the use 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 at the same time.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Your doctor will weigh the potential risks 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 may be used in breastfeeding women only 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 life).

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 package leaflet or as directed by your doctor or pharmacist. If you are unsure, you should speak to your doctor or pharmacist.

Dosage

Daktarin cream is applied to the affected areas of the skin, usually 2 times 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 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 contact your 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 your 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 questions about the use of this medicine, you should speak to your 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 (occurring in less than 1 in 10,000 patients).
After the medicine has been on the market, very rare cases of hypersensitivity reactions, including severe reactions such as anaphylaxis and angioedema, urticaria, contact dermatitis, rash, erythema, itching, skin inflammation, light spots on the skin, burning sensation on the skin, and disorders at the application site, including irritation, burning, itching, and a feeling of heat at the application site of Daktarin cream, have been observed.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Daktarin Cream

Store in a temperature below 25°C.
Medicines should be kept 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. You should ask your pharmacist how to dispose of medicines you 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 contains an aluminum tube (internally coated with epoxy resin, closed with a membrane and a PP or PE cap) containing 15 g or 30 g of cream, placed in a cardboard box.

Marketing Authorization Holder:

McNeil Healthcare (Ireland) Limited
Office 5, 6 & 7, Block 5
High Street, Tallaght
Dublin 24, D24 YK8N
Ireland

Manufacturer:

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
To obtain more detailed information, you should contact:
email: [email protected]

Date of Last Revision of the Leaflet: