Daktarin

Leaflet attached to the packaging: information for the user

Daktarin, 20 mg/g, medicinal powder for spraying on the skin

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, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Daktarin, medicinal powder for spraying on the skin, and what is it used for
• 2. Important information before using Daktarin, medicinal powder for spraying on the skin
• 3. How to use Daktarin, medicinal powder for spraying on the skin
• 4. Possible side effects
• 5. How to store Daktarin, medicinal powder for spraying on the skin
• 6. Package contents and other information

1. What is Daktarin, medicinal powder for spraying on the skin, and what is it used for

Daktarin, medicinal powder for spraying on the skin, contains the active substance miconazole.
Miconazole has antifungal effects, including on dermatophytes and yeast, 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 yeast. The itching subsides before other signs of recovery appear.

Indications for use

Daktarin, medicinal powder for spraying on the skin, is indicated, usually in combination with Daktarin cream, for the treatment of:

• interdigital foot fungus (athlete's foot),
• inguinal fungus. Daktarin, medicinal powder for spraying on the skin, can also be used prophylactically in shoes and socks.

2. Important information before using Daktarin, medicinal powder for spraying on the skin

on the skin

When not to use Daktarin, medicinal powder for spraying on the skin:

• 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, medicinal powder for spraying on the skin, the patient should discuss it with their doctor or pharmacist.
If symptoms of an allergic reaction or skin irritation occur, treatment should be discontinued and the doctor contacted.
Avoid contact between Daktarin, medicinal powder for spraying on the skin, and the eyes.
Daktarin, medicinal powder for spraying on the skin, contains talc. Inhaling the powder should be avoided to prevent respiratory irritation. For this reason, the medicine should be used with particular caution when treating infants and children.

Daktarin, medicinal powder for spraying on the skin, and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In patients taking oral anticoagulant medicines, such as warfarin, it is necessary to monitor their anticoagulant activity. 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, medicinal powder for spraying on the skin. Caution should be exercised when using other medicines concurrently.

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 should weigh the potential risks associated with the use of the medicine against the expected therapeutic benefits. It has not been established whether the active substance of the medicine, miconazole, passes into breast milk. For this reason, in breastfeeding women, Daktarin, medicinal powder for spraying on the skin, may only be used on the advice of a doctor.

Driving and operating machinery

No effects of the medicine on the ability to drive or operate machinery have been observed.

Daktarin, medicinal powder for spraying on the skin, contains ethanol

This medicine contains 255 mg of alcohol (ethanol) per dose (2550 mg), which is equivalent to 100 mg/g (10% w/w).
Daktarin, medicinal powder for spraying on the skin, may cause burning of damaged skin.

3. How to use Daktarin, medicinal powder for spraying on the skin

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Daktarin, medicinal powder for spraying on the skin, is applied to the affected areas of the skin, usually twice a day. Shake before use.
If Daktarin, medicinal powder for spraying on the skin, is used concurrently with Daktarin cream, it is recommended to use both forms of the medicine once a day.
Daktarin, medicinal powder for spraying on the skin, is used prophylactically once a day in shoes and socks.
The duration of treatment is from 2 to 6 weeks, depending on the location and severity of the changes.
After all symptoms and changes have subsided, 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 a higher dose of Daktarin, medicinal powder for spraying on the skin, than recommended

Using the medicine too frequently may cause skin irritation, which usually subsides after discontinuing the medicine.
The patient should contact their doctor immediately in case of accidental ingestion or inhalation of the medicine.
Daktarin, medicinal powder for spraying on the skin, is intended for use on the skin only, not for oral use.
Accidental inhalation:
Accidental inhalation of a large amount of Daktarin, medicinal powder for spraying on the skin, may cause respiratory obstruction. Respiratory arrest should be treated with intensive supportive therapy and oxygen administration. In case of respiratory disorders, the doctor may consider intubation, removal of accumulated content, and assisted breathing.

Missing a dose of Daktarin, medicinal powder for spraying on the skin

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

Stopping the use of Daktarin, medicinal powder for spraying on the skin

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Daktarin, medicinal powder for spraying on the skin, 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 was placed on the market, very rare cases of the following have been reported: 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, disorders at the application site, including irritation, burning, itching, heat sensation at the application site of Daktarin, medicinal powder for spraying on the skin.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Daktarin, medicinal powder for spraying on the skin

The medicine should be kept out of the sight and reach of children.
Store in a cool and dry place. Protect from direct sunlight and temperature.
The product is highly flammable. Pressurized container: heating may cause explosion. Keep away from heat sources, hot surfaces, sparks, open flames, and other ignition sources.
Smoking is prohibited. Do not spray near open flames or other ignition sources. Do not puncture or burn, even after use. Do not expose to temperatures above 50°C.
Do not use Daktarin, medicinal powder for spraying on the skin, 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 patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Daktarin, medicinal powder for spraying on the skin, contains

The active substance of the medicine is miconazole nitrate. 1 g of medicinal powder for spraying on the skin contains 20 mg of miconazole nitrate.
The other ingredients are: talc, hectorite stearalkonium, sorbitan sesquioleate, ethanol, propellant.

What Daktarin, medicinal powder for spraying on the skin, looks like and what the package contains

The medicine is a medicinal powder for spraying on the skin.
The package contains a pressurized container holding 100 g of medicinal powder for spraying on the skin.

Marketing authorization holder:

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

Importer:

JNTL Consumer Health (France) SAS
Domaine de Maigremont
Val de Reuil 27100
France
To obtain more detailed information, please contact:
email: [email protected]

Date of last revision of the leaflet: