Daktarin 2% powder

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Miconazole nitrate

Fáanlegur frá:

McNeil Products Ltd

ATC númer:

D01AC02

INN (Alþjóðlegt nafn):

Miconazole nitrate

Skammtar:

20mg/1gram

Lyfjaform:

Cutaneous powder

Stjórnsýsluleið:

Cutaneous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 13100200; GTIN: 5027097300139

Upplýsingar fylgiseðill

miconazole nitrate
_POWDER_
■
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:
■
There are some people who should not use this
medicine. _To find out if you are one of them. _
_See Section 2_
c
■
If you are allergic to the active substance, other
similar antifungal medicines or any of the other
ingredients of this medicine (listed in section 6)
■
SPEAK TO YOUR DOCTOR:
■
If you suffer from any of the conditions
mentioned in _Section 2_
c
■
If you are taking any OTHER MEDICINES. _See _
_Section 2_
c
■
FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS
PRODUCT CAREFULLY. _See Section 3_
c
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 associated
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 any doubt, talk to your doctor or pharmacist.
DO NOT USE THIS MEDICINE…
■
If you are allergic to the active substance, other
similar antifungal medicines or any of the other
ingredients of this medicine (listed in section 6)
■
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_)._ _
If you are not sure about any of the medicines you are
taking, show t

Vara einkenni

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 the full list of 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 the active substance, 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
topical
formulations
(see
Adverse
Reactions).
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 anticoagulant effect sh