Daktarin 2% cream

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Miconazole nitrate

متاح من:

Janssen-Cilag Ltd

ATC رمز:

D01AC02

INN (الاسم الدولي):

Miconazole nitrate

جرعة:

20mg/1gram

الشكل الصيدلاني:

Cutaneous cream

طريقة التعاطي:

Cutaneous

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 13100200; GTIN: 5012674021217

نشرة المعلومات

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
DAKTARIN
® 2% W/W CREAM
Miconazole nitrate
Daktarin is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again

If you have any further questions, ask your doctor or pharmacist

This medicine has been prescribed for you only. Do not pass it on to
others.
It may harm them, even if their signs of illness are the same as yours

If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Daktarin cream is and what it is used for
2. What you need to know before you use Daktarin cream
3. How to use Daktarin cream
4. Possible side effects
5. How to store Daktarin cream
6. Contents of the pack and other information
1. WHAT DAKTARIN CREAM IS AND WHAT IT IS USED FOR
The name of your medicine is Daktarin 2% w/w cream. It is called
Daktarin
cream in this leaflet.
Daktarin cream contains a medicine called miconazole. This belongs to
a group
of medicines called ‘antifungals’.
Daktarin cream is used for infections of the skin or nails caused by
fungi
including yeasts, and some bacteria. Infections may appear on the:

Trunk

Hands or feet

Scalp or outer ear

Groin
Daktarin cream works by destroying the fungus and associated bacteria
which
may be present.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DAKTARIN CREAM
DO NOT USE DAKTARIN CREAM:

If you are allergic to miconazole, any of the other ingredients of
this medicine
(listed in section 6) or to other similar antifungal medicines
Do not use this medicine if the above applies to you. If you are not
sure, talk to
your doctor or pharmacist before using Daktarin cream.
- 2 -
WARNINGS AND PRECAUTIONS
Keep this medicine away from your eyes. If you get any cream in your
eyes,
rinse with water straight away. Keep your eyes open when you rinse.
OTHER MEDICI

خصائص المنتج

OBJECT 1
DAKTARIN 2% W/W CREAM
Summary of Product Characteristics Updated 12-Aug-2016 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Daktarin 2% w/w cream.
2. Qualitative and quantitative composition
Miconazole nitrate 2% w/w.
(Each gram of cream contains 20mg of miconazole nitrate)
Excipients with known effect:
Benzoic acid
2 mg/g
Butylated hydroxyanisole 0.052 mg/g
For the full list of excipients, see Section 6.1
3. Pharmaceutical form
Cream
White homogeneous cream.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of mycotic infections of the skin and nails and
superinfections due to Gram-positive
bacteria.
4.2 Posology and method of administration
_Route of administration:_
Cutaneous use.
_Recommended dosage:_
For all ages:
Fungal infections of the skin: Apply some cream to the lesions two
times daily. Rub the cream into the
skin with your finger until it has fully penetrated. If the powder is
used with the cream, a once daily
application of both formulations is recommended. The duration of
therapy varies from 2 to 6 weeks
depending on the localisation and the severity of the lesion.
Treatment should be continued at least one
week after disappearance of all signs and symptoms.
Nail infections: Apply the cream once or twice daily to the lesions.
Treatment should be prolonged for 10
days after all lesions have disappeared to prevent relapse.
4.3 Contraindications
Daktarin 2% w/w cream is contraindicated in individuals with a known
hypersensitivity to
miconazole/miconazole nitrate, other imidazole derivatives or to any
of the excipients listed in section
6.1.
4.4 Special warnings and precautions for use
Severe hypersensitivity reactions, including anaphylaxis and
angioedema, have been reported during
treatment with Daktarin Cream and with other miconazole topical
formulations (see section 4.8). If a
reaction suggesting hypersensitivity or irritation should occur, the
treatment should be discontinued.
Daktarin 2% w/w cream must not come into contact with the mucosa of
the eyes.
Benzoic a