Daktarin

PATIENT INFORMATION LEAFLET: USER INFORMATION

Daktarin, 20 mg/g, medicinal powder

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 the patient information leaflet or as advised 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 you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, contact a doctor.

Table of contents of the leaflet

• 1. What is Daktarin medicinal powder and what is it 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 IS DAKTARIN MEDICINAL POWDER AND WHAT IS IT USED FOR

Daktarin medicinal powder 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 disappears before other signs of healing appear.

Indications for use

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

• intertrigo,
• inguinal and/or interdigital fungal infections caused by dermatophytes or yeast. Daktarin medicinal powder can also be used prophylactically in the middle of shoes and socks.

2. IMPORTANT INFORMATION BEFORE USING DAKTARIN MEDICINAL POWDER

When not to use Daktarin medicinal powder:

• if you are allergic to miconazole, other similar antifungal medicines, or any 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, discuss it with your doctor or pharmacist. If symptoms of hypersensitivity or skin irritation occur, treatment should be discontinued and a doctor consulted. Avoid contact of Daktarin medicinal powder with the eyes. Daktarin medicinal powder contains talc. Inhaling the powder should be avoided to prevent respiratory tract 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

Tell your doctor about all medicines you have taken recently, even those that are available without a prescription. In patients taking oral anticoagulant medicines, such as warfarin, it is necessary to monitor 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. Caution should be exercised when using other medicines concurrently.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. The doctor should consider the ratio of potential risk associated with the use of the medicine to the expected therapeutic benefits. It has not been determined whether the active substance of the medicine, miconazole, passes into breast milk. For this reason, in breastfeeding women, Daktarin medicinal powder may only be used on the advice of a doctor.

Driving and using machines

No effects of the medicine on the ability to drive and use machines have been observed.

3. HOW TO USE DAKTARIN MEDICINAL POWDER

This medicine should always be used exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Dosage

Daktarin medicinal powder is applied to the affected areas of the skin, usually 2 times a day. When Daktarin medicinal powder is used concurrently with Daktarin cream, it is recommended to use both forms of the medicine once a day. Daktarin medicinal powder is used prophylactically once a day in the middle of shoes and socks. 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, treatment should be continued for at least 1 week. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher dose of Daktarin medicinal powder than recommended

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

Missing a dose of Daktarin medicinal powder

Do not use a double dose to make up for a missed dose.

Stopping the use of Daktarin medicinal powder

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Daktarin medicinal powder can cause side effects. 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 marketing authorization of the medicine, very rare cases of hypersensitivity reactions, including severe reactions such as anaphylaxis and angioedema, urticaria, contact dermatitis, rash, erythema, pruritus, skin inflammation, pale 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 medicinal powder, have been observed.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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]. 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 MEDICINAL POWDER

Keep the medicine out of the reach and sight of children. There are no special precautions for storage. Do not use Daktarin medicinal powder after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Daktarin medicinal powder contains

The active substance of the medicine is miconazole nitrate. 1 g of medicinal powder contains 20 mg of miconazole nitrate. The other ingredients are zinc oxide, colloidal anhydrous silica, and talc.

What Daktarin medicinal powder looks like and what the pack contains

The packaging of the medicine is a polyethylene jar containing 20 g of medicinal powder.

Marketing authorization 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 more information, contact: email: [email protected]

Date of last revision of the leaflet: