Daktarin

Package leaflet: Information for the user

Daktarin, 20 mg/g, medicinal powder for skin spraying
Miconazoli nitras
Please read carefully all of this leaflet before using this medicine, because it contains
important information for you.

• This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your symptoms do not improve or worsen, you should contact your doctor.

Contents of the leaflet:

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

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

Daktarin medicinal powder for skin spraying 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 commonly accompanies infections caused by dermatophytes and yeasts. Itching subsides before other signs of healing appear.

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

• interdigital tinea pedis (athlete's foot),
• tinea cruris (jock itch).

Daktarin medicinal powder for skin spraying may also be used preventively inside shoes and socks.

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

Do not use Daktarin medicinal powder for skin spraying:

• if you are allergic to miconazole, to other similar antifungal medicines, or to 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 on broken or damaged skin.

Warnings and precautions
Before starting treatment with Daktarin medicinal powder for skin spraying, discuss it with your doctor or pharmacist.
If signs of hypersensitivity or skin irritation occur, discontinue treatment and contact your doctor.
Avoid contact of Daktarin medicinal powder for skin spraying with the eyes.
Daktarin medicinal powder for skin spraying contains talc. Inhalation of the powder should be avoided to prevent irritation of the respiratory tract. For this reason, the medicine should be used with particular caution when treating infants and children.
If you are taking oral anticoagulants such as warfarin, you should immediately stop using Daktarin medicinal powder for skin spraying and consult your doctor or pharmacist if unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black, tarry stools, or coffee-ground vomit occur during treatment. During treatment with Daktarin medicinal powder for skin spraying, international normalized ratio (INR) values should be closely monitored under the supervision of a healthcare professional.

Daktarin medicinal powder for skin spraying and other medicines
Inform your doctor, pharmacist, or dentist about all medicines you are currently taking, have recently taken, or plan to take.
Daktarin medicinal powder for skin spraying may affect the action of oral anticoagulant drugs (blood thinners), such as warfarin.
Patients taking oral anticoagulants require monitoring of anticoagulant effect. The effects and adverse reactions of certain other medicines (e.g., oral antidiabetic agents and phenytoin) may be intensified when used concomitantly with Daktarin medicinal powder for skin spraying. Caution should be exercised when using other medicines concurrently.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Your doctor should weigh the potential risks of using the medicine against the expected therapeutic benefits. It is not known whether the active substance, miconazole, passes into breast milk. Therefore, Daktarin medicinal powder for skin spraying should be used in breastfeeding women only on the advice of a doctor.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

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

3. How to use Daktarin, medicinal powder for skin spray

This medicine should always be used exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Apply Daktarin, medicinal powder for skin spray to the affected areas of skin, usually twice daily. Shake well before use.
When using Daktarin, medicinal powder for skin spray together with Daktarin cream, it is recommended to apply both forms of the medicine once daily.
For preventive use, apply Daktarin, medicinal powder for skin spray once daily inside shoes and socks.
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 the medicine's effect is too strong or too weak, consult your doctor.

Use of more than the recommended dose of Daktarin, medicinal powder for skin spray
Overuse of the medicine may cause skin irritation, which usually resolves after discontinuing the product.
Seek immediate medical attention if the medicine is accidentally swallowed or inhaled.
Daktarin, medicinal powder for skin spray is for topical use on the skin only and must not be taken orally.

Accidental inhalation:
Accidental inhalation of a large amount of Daktarin, medicinal powder for skin spray may cause airway obstruction. Respiratory arrest should be treated with intensive supportive care and oxygen administration. If breathing difficulties occur, the physician may consider endotracheal intubation, removal of obstructing material, and assisted ventilation.

Missed dose of Daktarin, medicinal powder for skin spray
Do not use a double dose to make up for a missed dose.

Stopping Daktarin, medicinal powder for skin spray
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Daktarin, medicated powder for skin spraying, may cause adverse reactions, although not everyone experiences them.
The frequency of possible adverse reactions listed below is defined as follows:
very rare (occurring in fewer than 1 in 10,000 patients).
Very rare cases have been observed after marketing of the product: hypersensitivity reactions, including severe reactions such as anaphylactic reactions and angioedema, urticaria, contact dermatitis, rash, erythema, pruritus, dermatitis, skin discoloration, burning sensation on the skin, local reactions at the site of application, including irritation, burning, itching, and sensation of warmth at the site of application of Daktarin, medicated powder for skin spraying.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Daktarin, medicated powder for skin spraying

Keep the medicine out of the sight and reach of children.
Store in a cool and dry place. Protect from direct sunlight and heat.
The product is extremely flammable. Pressurised container: heating may cause an explosion. Store
away from heat sources, hot surfaces, sparks, open flames and other sources of ignition.
No smoking. Do not spray near open flame or other source of ignition. Do not pierce or burn, even
after use. Do not expose to temperatures above 50°C.
Do not use Daktarin, medicated powder for skin spraying after the expiry date stated on the
packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist
what to do with medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Daktarin, medicated spray powder for skin contains
The active substance is miconazole nitrate. 1 g of medicated spray powder for skin contains
20 mg of miconazole nitrate.
The other ingredients are: talc, stearalkonium hectorite, sorbitan sesquioleate, ethanol, propellant.
What Daktarin, medicated spray powder for skin looks like and contents of the pack
The medicine is in the form of a medicated spray powder for skin.
The medicine pack is a pressurised container containing 100 g of medicated spray powder for skin.
Marketing Authorisation 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
For further information, please contact:
email: [email protected]