Daktacort 2% / 1% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydrocortisone; Miconazole nitrate

Available from:

Janssen Sciences Ireland UC

ATC code:

D07CA; D07CA01

INN (International Name):

Hydrocortisone; Miconazole nitrate

Dosage:

2% / 1% percent weight/weight

Pharmaceutical form:

Cream

Therapeutic area:

Corticosteroids, weak, combinations with antibiotics; hydrocortisone and antibiotics

Authorization status:

Marketed

Authorization date:

1996-12-16

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
DAKTACORT
® 2% / 1% W/W CREAM
Miconazole nitrate / hydrocortisone
Daktacort 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 Daktacort cream is and what it is used for
2 What you need to know before you use Daktacort cream
3 How to use Daktacort cream
4 Possible side effects
5 How to store Daktacort cream
6 Contents of the pack and other information
1 WHAT DAKTACORT CREAM IS AND WHAT IT IS USED FOR
The name of your medicine is Daktacort 2% / 1% w/w cream. It is called
‘Daktacort cream’ in this leaflet.
Daktacort cream is a medicine which is used to treat inflamed
conditions of the
skin such as eczema and dermatitis which may be caused by infection
with
certain fungi and bacteria.
The cream contains the following ingredients:

Miconazole nitrate - an antifungal which works by destroying both the
fungus that causes the infection and some of the associated bacteria
which may also be present.

Hydrocortisone - a mild ‘topical steroid’ which reduces
inflammation,
swelling, redness and itching of the skin.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE DAKTACORT CREAM
DO NOT USE DAKTACORT CREAM:

if you are allergic to miconazole nitrate, hydrocortisone, any of the
other
ingredients of this medicine (listed in section 6) or to other similar
antifungal
medicines

if you have any other skin problems such as cold sores, herpes,
chicken pox
or shingles. Only use it for the skin problem that you showed the
doctor

Summary of Product characteristics

Health Products Regulatory Authority
03 November 2020
CRN009V66
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daktacort 2% / 1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.
Excipients with known effect
Contains 0.2% w/w benzoic acid (E210) and 0.0052% w/w butylated
hydroxyanisole (E320).
5 g: This medicine contains 10 mg benzoic acid in each tube of 5 g
cream which is equivalent to 2 mg/g cream.
10 g: This medicine contains 20 mg benzoic acid in each tube of 10 g
cream which is equivalent to 2 mg/g cream.
15 g: This medicine contains 30 mg benzoic acid in each tube of 15 g
cream which is equivalent to 2 mg/g cream.
30 g: This medicine contains 60 mg benzoic acid in each tube of 30 g
cream which is equivalent to 2 mg/g cream.
75 g: This medicine contains 150 mg benzoic acid in each tube of 75 g
cream which is equivalent to 2 mg/g cream.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White, homogenous, odourless cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Daktacort is used for the topical treatment of skin conditions where
inflammation and infection by susceptible organisms
co-exist. The properties of Daktacort indicate it particularly for the
initial stages of treatment. Once the inflammatory symptoms
have disappeared, treatment can be continued with miconazole nitrate
20mg/g cream.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous administration
Apply one to three times daily to the affected area or as directed by
the physician.
Daktacort cream should be rubbed in gently until it has been
completely penetrated into the skin. The treatment with
Daktacort cream (or subsequently with miconazole nitrate 20 mg/g
cream) should be continued without interruption until the
lesion has completely disappeared (usually after 2 to 6 weeks).
_Elderly_
Thinning of the skin occurs naturally and especially in the elderly,
and is a common risk with prolonged/excessive use of
corticosteroids.