Daktarin Cream 2.0% w/w

国家: 马耳他

语言: 英文

来源: Malta Medicines Authority

有效成分:

MICONAZOLE NITRATE

可用日期:

Johnson & Johnson Hellas Consumer AE Aegialias & Epidavrou 4, Maroussi, 15125, Athens, Greece

ATC代码:

D01AC02

INN（国际名称）:

MICONAZOLE NITRATE 20 mg/g

药物剂型:

CREAM

组成:

MICONAZOLE NITRATE 20 mg/g

处方类型:

OTC

治疗领域:

ANTIFUNGALS FOR DERMATOLOGICAL USE

授权状态:

Authorised

授权日期:

2006-12-21

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
DAKTARIN
® 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 cream.
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, other similar antifungal medicines
or any of the
other ingredients of this medicine (listed in section 6).
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.
WARNINGS AND PRECAUTIONS:
Avoid contact with the eyes. If you get any cream in your eyes, rinse
with water straight away.
Keep your eyes open when you rinse.
- 1 -
Document ID:
Version:
Status:
3.0
J0342566
Approved
OTHER MEDICINES AND DAKTARIN CREAM
Plea

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Daktarin 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
Version :
Status :
Document ID :
3.0
J0342559
Approved
should be prolonged for 10 days after all lesions have disappeared to
prevent
relapse.
4.3
CONTRAINDICATIONS
Daktarin 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 Cream
must not come into contact with the mucosa of the eyes
Benzoic acid may cause local irritation