Daktarin

Daktarin, 20 mg/g, medicinal powder
Miconazoli nitras

• Please read the following information carefully before using the 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 you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, consult a doctor.

Table of contents

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

1. WHAT DAKTARIN MEDICINAL POWDER IS AND WHAT IT IS USED FOR

Daktarin medicinal powder contains the active substance miconazole. Miconazole has antifungal activity, particularly against dermatophytes and yeasts, as well as antibacterial activity against Gram-positive bacilli and cocci. Miconazole is also effective in the treatment of secondarily infected fungal lesions. Miconazole usually relieves itching of the skin, which often accompanies infections caused by dermatophytes and yeasts. Itching subsides before other signs of healing appear.

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

• diaper dermatitis (napkin rash),
• tinea cruris and/or interdigital tinea, caused by dermatophytes or yeasts.

Daktarin medicinal powder may also be used prophylactically inside shoes and socks.

2. IMPORTANT INFORMATION BEFORE USING DAKTARIN MEDICATED POWDER

MEDICATED POWDER
When not to use Daktarin medicated powder:

• if you are 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 to use Daktarin medicated powder, discuss it with your doctor or pharmacist.
If symptoms of allergy or skin irritation occur, treatment should be discontinued and you should contact your doctor.
Avoid contact of Daktarin medicated powder with the eyes.
Daktarin medicated powder contains talc. Avoid inhaling the powder to prevent irritation of the respiratory tract. For this reason, the medicine should be used with particular caution when treating infants and children.
If the patient is taking oral anticoagulant medicines such as warfarin, treatment with Daktarin medicated powder should be stopped immediately and medical advice should be sought from 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 the supervision of a healthcare professional.

Daktarin medicated powder and other medicines
Tell your doctor, pharmacist, or dentist about all medicines you are currently taking, have recently taken, or plan to take.
Daktarin medicated powder may affect the action of oral anticoagulant medicines (blood-thinning medicines), 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 concomitantly.

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 consider the potential risks of using the medicine against the expected therapeutic benefits. It has not been established whether the active substance of the medicine – miconazole – passes into breast milk. Therefore, Daktarin medicated powder should be used in breastfeeding women only on medical advice.

Driving and operating machinery
No effect of the medicine on the ability to drive vehicles or operate machinery has 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 your doctor 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.
If Daktarin medicated powder is being used at the same time as Daktarin cream, it is recommended to use both forms once daily.
Daktarin medicated powder used preventively 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 the effect of the medicine is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Daktarin medicated powder
Overuse of the medicine may cause skin irritation, which usually resolves after discontinuation of the medicine.
Seek immediate medical advice in case of accidental ingestion or inhalation of the medicine.
Daktarin medicated powder is for external use on the skin only and is not intended for oral use.
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 assisted ventilation.
Missed dose of Daktarin medicated powder
Do not use a double dose to make up for a missed dose.
Stopping Daktarin medicated powder
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Daktarin, medicinal powder may cause adverse reactions.
The frequency of possible adverse reactions listed below is defined as follows:
very rare (occurring in fewer than 1 in 10,000 patients).
Since the medicine has been placed on the market, hypersensitivity reactions have very rarely been observed, 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 reactions at the application site, including irritation, burning, itching, and sensation of warmth at the site of application of Daktarin, medicinal powder.

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 of Adverse Drug Reactions 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
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
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 reach and sight of children.
No special storage instructions apply.
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 wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. 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 components are zinc oxide, anhydrous colloidal silica, talc.

What Daktarin medicinal powder looks like and contents of the pack
The medicine is packed in a polyethylene jar containing 20 g of medicinal powder.

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

Manufacturer:
Lusomedicamenta – Sociedade Técnica Farmacêutica S.A.
Estrada Consiglieri Pedroso 69-B
Queluz de Baixo
2730-055 Barcarena, Portugal

For further information, please contact:
email: [email protected]