Daktacort ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Miconazole nitrate; Hydrocortisone

Available from:

Janssen-Cilag Ltd

ATC code:

D01AC20

INN (International Name):

Miconazole nitrate; Hydrocortisone

Dosage:

20mg/1gram ; 10mg/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000; GTIN: 5012674018552

Patient Information leaflet

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
DAKTACORT
® 2% / 1% W/W OINTMENT
Miconazole nitrate and 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 ointment is and what it is used for
2. What you need to know before you use Daktacort ointment
3. How to use Daktacort ointment
4. Possible side effects
5. How to store Daktacort ointment
6. Contents of the pack and other information
1. WHAT DAKTACORT OINTMENT IS AND WHAT IT IS USED FOR
The name of your medicine is Daktacort 2% / 1% w/w ointment. It is
called
Daktacort ointment in this leaflet.
Daktacort ointment 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 ointment 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 OINTMENT
DO NOT USE DAKTACORT OINTMENT 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.

You have any other skin problems such as cold sores, herpes, chicken
pox
or shingles. Only use it for the skin problem that y

Summary of Product characteristics

OBJECT 1
DAKTACORT 2% / 1% W/W OINTMENT
Summary of Product Characteristics Updated 08-May-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Daktacort™ 2% / 1% w/w ointment.
2. Qualitative and quantitative composition
Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.
3. Pharmaceutical form
White, odourless, fatty ointment.
4. Clinical particulars
4.1 Therapeutic indications
For the topical treatment of inflamed dermatoses where infection by
susceptible organisms and
inflammation co-exist, eg intertrigo and infected eczema.
Moist or dry eczema or dermatitis including atopic eczema, primary
irritant or contact allergic eczema or
seborrhoeic eczema including that associated with acne.
Intertriginous eczema including inframammary intertrigo, perianal and
genital dermatitis.
Organisms which are susceptible to miconazole are dermatophytes and
pathogenic yeasts (eg _Candida_
spp.). Also many Gram-positive bacteria including most strains of
_Streptococcus_ and _Staphylococcus_.
4.2 Posology and method of administration
For topical administration.
Apply the ointment two or three times a day to the affected area,
rubbing in gently until the ointment has
been absorbed by the skin.
The properties of Daktacort indicate its use particularly for the
initial stages of treatment. Because of its
corticosteroid content avoid long-term treatment with Daktacort. Once
the inflammatory symptoms have
disappeared (after about 7 days), treatment can be continued where
necessary with miconazole nitrate
20mg/g cream or powder. Treatment should be continued without
interruption until the lesion has
completely disappeared (usually after 2 to 5 weeks).
If after about 7 days' application, no improvement has occurred,
cultural isolation of the offending
organism should be followed by appropriate local or systemic
antimicrobial therapy.
The same dosage applies to both adults and children.
_Elderly _
Natural thinning of the skin occurs in the elderly, hence
corticosteroids should be used sparingly and for
short periods of time.
_Paedia