DAKTARIN 2.0 %w/w Cream

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

MICONAZOLE NITRATE

Dostupné z:

McNeil Healthcare (Ireland) Ltd

ATC kód:

A01AB09

INN (Medzinárodný Name):

MICONAZOLE NITRATE

Dávkovanie:

2.0 %w/w

Forma lieku:

Cream

Typ predpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Antiinfectives and antiseptics for local oral treatment

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2009-09-25

Príbalový leták

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 Cr
eam 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 Cr
eam is and what it is used for
2. Befor
e you use Daktarin Cr
eam
3. How to use Daktarin Cr
eam
4. Possible side ef
fects
5. How to stor
e Daktarin Cr
eam
6. Further information
1

WHAT DAKTARIN CR
EAM IS AND 
WHAT IT IS USED FOR
Daktarin 2% Cr
eam is a medicine which is used in the 
tr
eatment of fungal and associated bacterial infections 
of the skin. Skin infections may appear on the hands, 
feet, outer ear
, trunk or gr
oin and include athlete’
s foot, 
dhobie itch and intertrigo. Daktarin 2% Cr
eam is also 
ef
fective against infected nappy rash. The cr
eam 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. It also has 
moisturising pr
operties to help soothe cracked, r
ed skin.
This medicine is for use in adults and childr
en of all ages.
2
  BEFOR
E YOU USE DAKTARIN 
CR
EAM
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 CR
EAM
■
  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 this applies to you, 
GET ADVICE FR
OM A DOCTOR OR 
PHAR
MACIST WITHOUT USING DAKTARIN 2% CR
EAM
. 
TAKE SPECIAL CAR
E

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daktarin 2% w/w Cream.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains miconazole nitrate 2% w/w (20 mg/g).
Excipients: contains 0.2% w/w benzoic acid (E210) and 0.005% w/w Butylated hydroxyanisole (E320).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White homogenous cream.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous administration.
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 severity of the lesion. Treatment should
continue for at least one week after the disappearance of all signs and symptoms.
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 formulations. 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 (E210) can mildly irritate the skin, eyes and mucosal membranes.
Butylated hydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and
mucosa membranes.
HEALTH PRODUCTS REGULATORY AUTHORITY
__________