DAKTACORT 2% / 1% W/W CREAM

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MICONAZOLE NITRATE ; HYDROCORTISONE

Available from:

Janssen-Cilag Ltd

ATC code:

D07CA01

INN (International Name):

MICONAZOLE NITRATE ; HYDROCORTISONE

Dosage:

2% / 1% %w/w

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

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.
Contains 0.2% w/w benzoic acid (E210) and 0.0052% butylated
hydroxyanisole (E320).
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.
Corticosteroids should therefore be used sparingly and for short
periods of time.
_Paediatrics_
In children, caution is advised when Daktacort Cream is applied to
extensive surface areas or under occlusive dressings
including baby napkins (diapers). In infants, use with occlusive
dressings is contraindicated (see section 4.3) and the
long- term continuous topical corticosteroid therapy should be avoided
(see section 4.4).
4.3 CONTRAINDICATIONS
1.
Hypersensitivity to miconazole nitrate, other imidazole derivatives,
hydrocortisone or to any of the excipients
listed in section 6.1.
2.
Use in infants in conjunction with occlusion.
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