Daktarin
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Daktarin, 20 mg/g (2%) cream
Miconazole nitrate
Please read this 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 the
physician or pharmacist.
- Keep this leaflet, so that you can read it again if necessary.
- If you need advice or further information, please consult your doctor or pharmacist.
- If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement or if you feel worse, consult your doctor.
Table of contents of the leaflet
- What Daktarin cream is and what it is used for
- Important information before using Daktarin cream
- How to use Daktarin cream
- Possible side effects
- How to store Daktarin cream
- Contents of the pack and other information
1. What Daktarin cream is and what it is used for
Daktarin cream contains the active substance miconazole. Miconazole has antifungal activity 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 often accompanies infections caused by dermatophytes and yeasts. Itching subsides before other signs of healing appear.
Indications
Daktarin cream is indicated for the treatment of fungal skin infections caused by dermatophytes, yeasts, and other fungi, such as tinea of the scalp, body, hands, groin (tinea cruris), and interdigital fungal infection of the feet (athlete's foot).
Due to its antibacterial action, Daktarin cream may also be used in fungal infections secondarily infected by bacteria (e.g. infected diaper dermatitis).
2. Information before using Daktarin cream
When not to use Daktarin cream:
- 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 scalp, mucous membranes, nails, or on broken skin.
Warnings and precautions
Before starting treatment with Daktarin cream, discuss this 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 cream with the eyes.
Daktarin cream and other medicines
You should tell your doctor about all medicines you are currently taking or have recently taken,
as well as any medicines you plan to take.
In patients taking oral anticoagulant medicines such as warfarin, monitoring of anticoagulant effect is necessary. The effects and adverse reactions associated with some other medicines (e.g. oral antidiabetic agents and phenytoin), when used concomitantly with Daktarin cream, may be enhanced.
Caution should be exercised when using other medicines simultaneously.
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 will consider the potential risk 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 cream should be used in breastfeeding women only on medical advice.
Driving and operating machinery
No influence of the medicine on the ability to drive or operate machinery has been observed.
Daktarin cream contains 2 mg of benzoic acid in each g of cream
Benzoic acid may cause local irritation. Benzoic acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
Daktarin cream contains butylated hydroxyanisole
This medicine may cause a local skin reaction (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
3. How to use Daktarin cream
This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage
Daktarin cream should be applied to the affected areas of skin, usually twice daily.
If Daktarin cream is being used at the same time as Daktarin medicinal powder, it is recommended to use both forms of the medicine once daily.
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 the medicine is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Daktarin cream
Excessive use of the medicine may cause skin irritation, which usually resolves after discontinuation of treatment.
Seek immediate medical advice in case of accidental ingestion.
Daktarin cream is for external use on the skin only and must not be taken orally.
Missed dose of Daktarin cream
Do not apply a double dose to make up for a missed dose.
Stopping Daktarin cream
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, Daktarin cream may cause adverse reactions, although not everyone experiences them.
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 shown very rare occurrences of: 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 site reactions including irritation, burning, itching, and sensation of warmth at the site of application of Daktarin cream.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Daktarin cream
Do not store above 25°C.
Keep the medicine in a place invisible and inaccessible to children.
Do not use Daktarin cream 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 how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the package and other information
What Daktarin cream contains
- The active substance is miconazole nitrate. 1 g of cream contains 20 mg of miconazole nitrate.
- The other ingredients are butylhydroxyanisole, benzoic acid, liquid paraffin, glyceryl monooleate macrogol ethers, macrogol 6 stearyl ether and macrogol 32 stearyl ether, purified water.
What Daktarin cream looks like and contents of the pack
The medicine is supplied in a tube containing 30 g of cream, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Ireland, country of export:
JNTL Consumer Health I (Ireland) Ltd. Block 5, High Street, Tallaght, Dublin 24, D24 YK8N, Ireland
Manufacturer:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B2340, Beerse, Belgium
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Relabelled and repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Irish Marketing Authorisation number, country of export: PA23490/028/001
Parallel Import Licence number: 50/25