DAKTARIN 2.0 %w/w Cutaneous Powder

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

MICONAZOLE NITRATE

Disponible des:

McNeil Healthcare (Ireland) Ltd

Codi ATC:

A01AB09

Designació comuna internacional (DCI):

MICONAZOLE NITRATE

Dosis:

2.0 %w/w

formulario farmacéutico:

Cutaneous Powder

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Antiinfectives and antiseptics for local oral treatment

Estat d'Autorització:

Authorised

Data d'autorització:

2009-08-14

Informació per a l'usuari

TOP
READ ALL OF THIS LEAFLET CAR
EFULLY BECAUSE IT 
CONTAINS IMPORTANT INFOR
MATION FOR YOU.
This medicine is available without pr
escription. 
However you still need to take Daktarin Powder 
car
efully to get the best r
esults fr
om it.
■
  Keep this leaflet. Y
ou may need to r
ead it again.
■
  Ask your pharmacist if you need mor
e information 
or advice.
■
  Y
ou must contact a doctor if your symptoms 
worsen or do not impr
ove.
■
  If any of the side ef
fects get serious or if you 
notice any side ef
fects not listed in this leaflet, 
please contact your doctor or pharmacist.
IN THIS LEAFLET
1. What Daktarin Powder is and what it is used for
2. Befor
e you take Daktarin Powder
3. How to take Daktarin Powder
4. Possible side ef
fects
5. How to stor
e Daktarin Powder
6. Further information
1
  WHAT DAKTARIN POWDER IS 
AND WHAT IT IS USED FOR
Daktarin Powder is a medicine which is used to tr
eat

infections of the skin which may appear on the hands,

feet, outer ear
, trunk or gr
oin. It is also used to tr
eat

nappy rash. The powder contains miconazole nitrate

which works by destr
oying both the fungus that

causes the infection and some of the associated

bacteria which may also be pr
esent. The powder

helps to dry the skin as well as tr
eat the infection.
This medicine is for use in adults and childr
en of all 
ages.
2
  BEFOR
E YOU TAKE DAKTARIN 
POWDER
This medicine is suitable for most adults and 
childr
en but a few people should not use it. If you 
ar
e in any doubt, talk to your doctor or pharmacist. 
DO NOT USE DAKTARIN POWDER
■
  If you ar
e aller
gic to the active substance, 
other similar antifungal medicines or any of 
the other ingr
edients of this medicine (listed 
in section 6).
If any of these apply to you, 
GET ADVICE FR
OM 
A 
DOCTOR OR PHAR
MACIST WITHOUT USING 
DAKTARIN POWDER
. 
TAKE SPECIAL CAR
E WITH DAKTARIN POWDER
■
  A
void contact with the eyes.
■
  If you experience any irritation or sensitivity 
to the powder
, s

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daktarin 2% w/w Cutaneous Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains miconazole nitrate 2% w/w (20mg/g)
Each gram of cutaneous powder contains 20mg of Miconazole Nitrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous powder
White free-flowing powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical treatment of fungal infections of the skin and secondary infections due to Gram-positive bacteria. The
powder may be applied separately or with the cream to skin lesions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous administration.
Apply powder once or twice daily to affected areas until the lesions have completely healed.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, 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
miconazole topical formulations. 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 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
cutaneous application (See Section 5.2 Pharmacokinetic properties), clinically relevant interactions are unlikely to
occur.