Daktarin
Poland
Table of Contents
Attention!
Keep the package leaflet. Information on the immediate packaging is in a foreign language.
Daktarin, 20 mg/g, medicinal powder
Miconazoli nitras
Please read the entire package leaflet carefully before using this 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 a doctor or pharmacist.
- Keep this leaflet for future reference.
- If advice or additional information is needed, consult a pharmacist.
- If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
- If there is no improvement or if the patient feels worse, contact a doctor.
Table of contents of the leaflet
- What Daktarin medicinal powder is and what it is used for
- Important information before using Daktarin medicinal powder
- How to use Daktarin medicinal powder
- Possible side effects
- How to store Daktarin medicinal powder
- Contents of the packaging and other information
1. WHAT DAKTARIN MEDICINAL POWDER IS AND WHAT IT IS USED FOR
Daktarin medicinal powder contains the active substance: miconazole nitrate. Miconazole has antifungal activity, particularly against dermatophytes and yeasts, and 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 become apparent.
Indications
Daktarin medicinal powder is indicated, usually in combination with Daktarin cream, for the treatment of:
- diaper dermatitis,
- tinea cruris and/or interdigital tinea caused by dermatophytes or yeasts.
Daktarin medicinal powder may also be used preventively inside shoes and socks.
2. IMPORTANT INFORMATION BEFORE USING DAKTARIN MEDICATED POWDER
MEDICATED POWDER
When not to use Daktarin Medicated Powder:
- if the patient is allergic to miconazole, other similar antifungal medicines, or any of the ingredients of this medicine (listed in section 6),
- for the treatment of fungal infections of the scalp, mucous membranes, nails, or broken skin.
Warnings and precautions
Before starting treatment with Daktarin Medicated Powder, consult your doctor or pharmacist.
If symptoms of hypersensitivity or skin irritation occur, discontinue treatment and contact your doctor.
Avoid contact of Daktarin Medicated Powder with the eyes.
Daktarin Medicated Powder contains talc. Inhalation of the powder should be avoided to prevent respiratory tract irritation. For this reason, the product should be used with particular caution when treating infants and children.
If the patient is taking oral anticoagulant medicines such as warfarin, discontinue use of Daktarin Medicated Powder immediately and consult a doctor or pharmacist if unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in urine, black tarry stools, or coffee-ground vomit occur during treatment with Daktarin Medicated Powder. During treatment with Daktarin Medicated Powder, the international normalized ratio (INR) should be closely monitored under supervision of a healthcare professional.
Daktarin Medicated Powder and other medicines
Inform your doctor, pharmacist, or dentist about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Daktarin Medicated Powder may affect the action of oral anticoagulant medicines (blood thinners), such as warfarin.
In patients taking oral anticoagulants, monitoring of anticoagulant effect is necessary. The effects and adverse reactions associated with the use of certain other medicines (e.g. oral antidiabetic medicines and phenytoin) may be intensified when used concomitantly with Daktarin Medicated Powder. Caution should be exercised when using other medicines concurrently.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The doctor should weigh the potential risks of using the medicine against the expected therapeutic benefits. It has not been established whether the active ingredient of the medicine – miconazole – passes into breast milk. Therefore, Daktarin Medicated Powder should only be used during breastfeeding under medical supervision.
Driving and operating machinery
No effects on the ability to drive vehicles or operate machinery have been observed.
3. HOW TO USE DAKTARIN MEDICATED POWDER
This medicine should always be used exactly as described in this patient information leaflet or as directed by a physician or pharmacist.
If in doubt, consult your doctor or pharmacist.
Dosage
Daktarin medicated powder should be applied to affected areas of skin, usually twice daily.
When Daktarin medicated powder is used simultaneously with Daktarin cream, it is recommended to use both formulations once daily.
For preventive use, Daktarin medicated powder should be applied 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 that the effect of Daktarin medicated powder is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Daktarin medicated powder
Excessive use of the medicine may cause skin irritation, which usually resolves after discontinuation of the product.
Seek immediate medical advice in case of accidental ingestion or accidental inhalation of the powder.
Daktarin medicated powder is intended for topical use only, not for oral administration.
Accidental inhalation:
Accidental inhalation of a large amount of Daktarin medicated powder 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 application of assisted ventilation.
Missed dose of Daktarin medicated powder
Do not use a double dose to make up for a missed dose.
Discontinuation of Daktarin medicated powder
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like any medicine, Daktarin, medicinal powder may cause adverse reactions.
The frequency of the possible adverse reactions listed below is defined as follows:
very rare (occurring in fewer than 1 in 10,000 patients).
Post-marketing experience has very rarely reported hypersensitivity reactions, including severe reactions such as anaphylactic reactions and angioedema, urticaria, contact dermatitis, rash, erythema, pruritus, skin inflammation, light skin spots, burning sensation on the skin, local application site reactions including irritation, burning, itching, and sensation of warmth at the site of application of Daktarin, medicinal powder.
Reporting of adverse reactions
If any adverse reactions occur, including any 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 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. HOW TO STORE DAKTARIN MEDICATED POWDER
Keep the medicine out of the sight and reach of children.
No special storage instructions are required.
Do not use Daktarin medicated powder 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 your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. PACK CONTENTS AND OTHER INFORMATION
What Daktarin medicinal powder contains
The active substance is miconazole nitrate. 1 g of medicinal powder contains 20 mg of miconazole nitrate.
Other ingredients: zinc oxide, anhydrous colloidal silicon dioxide, talc.
What Daktarin medicinal powder looks like and contents of the pack
The medicinal product is packed in a plastic jar containing 20 g of medicinal powder, placed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Greece, country of export:
Johnson & Johnson Hellas Consumer AE
Aigialeias & Epidavrou 4
15125 Marousi
Athens
Greece
Manufacturer:
Lusomedicamenta-Sociedade Técnica Farmacêutica SA
Estrada Consiglieri Pedroso 69-B
2730-055 Barcarena Queluz de Baixo
Portugal
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Marketing Authorisation Number in Greece, country of export: 30830/02-05-2012
1774/17.01.1996
8533/06.02.2007
Parallel import licence number: 204/10