Daktarin

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MICONAZOLE NITRATE

Available from:

Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium

ATC code:

D01AC02

INN (International Name):

MICONAZOLE NITRATE

Pharmaceutical form:

CUTANEOUS POWDER

Composition:

MICONAZOLE NITRATE 20 milligram(s)/gram

Prescription type:

OTC

Therapeutic area:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Authorization status:

Authorised

Authorization date:

2006-12-20

Patient Information leaflet

Page 1 of 4
DAKTARIN POWDER
Miconazole nitrate

This medicine is used to treat fungal and bacterial infections of the
skin.

This medicine is for use by adults and children of all ages.

DO NOT USE THIS MEDICINE:
o
There are some people who should not use this medicine. _To find out
if you are one of _
_them. See Section 2. _
o
If you have ever had a bad reaction to any of the ingredients. _For
the list of ingredients. _
_See Section 6 _

SPEAK TO YOUR DOCTOR:_ _
o
If you suffer from any of the conditions mentioned in _Section 2 _
o
If you are taking any OTHER MEDICINES._ See Section 2 _

FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT CAREFULLY._ SEE
SECTION 3. _
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE.
Keep the leaflet: you might
need it again.
1.
WHAT THE MEDICINE IS FOR_ _
Daktarin Powder is a medicine which is used to treat infections of the
skin which may appear on the
hands, feet, outer ear, trunk or groin. It is also used to treat nappy
rash. The powder contains
miconazole nitrate which works by destroying both the fungus that
causes the infection and some of
the associate bacteria which may also be present. The powder helps to
dry the skin as well as treat the
infection.
This medicine is for use in adults and children of all ages.
2.
BEFORE USING THIS MEDICINE
This medicine is suitable for most adults and children but a few
people should not use it. If you are in
doubt, talk to you doctor or pharmacist.
DO NOT USE THIS MEDICINE…

If you have ever had a BAD REACTION to any of the ingredients.

If your infection is on your HAIR or NAILS.
If any of these apply to you, GET ADVICE FROM A DOCTOR OR PHARMACIST
WITHOUT USING
DAKTARIN POWDER. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING…

_Oral anticoagulants_ (drugs used to THIN THE BLOOD, such as
_warfarin_)
Page 2 of 4
If you are not sure about any of the medicines you are taking, show
the bottle or pack to you
pharmacist.
IF YOU ARE PREGNANT OR BREAST-FEEDING

Ask your doctor or pharmacist fo

Summary of Product characteristics

Page
1
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5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Daktarin Powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Daktarin powder contains miconazole nitrate 2.0% w/w
(Each gram of powder contains 20mg of miconazole nitrate)
For excipients see Section 6.1
3.
PHARMACEUTICAL FORM
Cutaneous powder.
White powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of mycotic infections of the skin and
superinfections due to
Gram positive bacteria.
_4.2_
_ _
POSOLOGY AND METHOD OF ADMINISTRATION
Daktarin powder is for cutaneous administration.
_Adults _
Twice daily application of powder to the lesions, treatment being
prolonged for
some 10 days after all lesions have disappeared to prevent relapse.
_Elderly and children _
_ _
As for adults.
4.3
CONTRAINDICATIONS
Hypersensitivity to miconazole/miconazole nitrate, other imidazole
derivatives
or to any
of the excipients listed in section 6.1.
The powder should not be recommended for the treatment of infections
of the
hair and nails.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Severe hypersensitivity reactions, including anaphylaxis and
angioedema, have
been reported during treatment with Daktarin Powder and with other
miconazole
Page
2
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5
topical formulations (see section 4.8).
If a reaction suggesting hypersensitivity or
irritation should occur, the treatment should be discontinued.
Daktarin powder must not come into contact with the mucosa of the
eyes.
Daktarin powder contains talc. Avoid inhalation of the powder to
prevent irritation
of the airways. In particular, when treating infants and children,
careful
application should be used to prevent inhalation by the child.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Miconazole administered systemically is known to inhibit CYP3A4/2C9.
Due to
the limited systemic availability after topical application,
clinically relevant
interactions are rare. However, in patients on oral anticoagulants,
such as warfarin,
caution should be exercised and anticoag