Daktacort Hydrocortisone cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone; Miconazole nitrate

Available from:

McNeil Products Ltd

ATC code:

D01AC20

INN (International Name):

Hydrocortisone; Miconazole nitrate

Dosage:

10mg/1gram ; 20mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000; GTIN: 5027097795331

Patient Information leaflet

■
This medicine is used to treat inflamed sweat rash and Athlete’s
Foot
skin infections.
■
This medicine is for use by adults and children aged 10 years and
over.
■
DO NOT USE THIS MEDICINE:
■
There are some people who should not use this medicine.
_To find out if you are one of them. See Section 2_
c
■
If you are allergic to the active substance, other similar antifungal
medicines or any of the other ingredients of this medicine
(listed in section 6)
c
■
SPEAK TO YOUR DOCTOR:
■
If you suffer from any of the conditions mentioned in _Section 2_
c
■
If you are taking any OTHER MEDICINES. _See Section 2_
c
■
FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT CAREFULLY.
_See Section 3_
c
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE.
Keep the leaflet: you might need it again.
1
WHAT THE MEDICINE IS FOR
Daktacort Hydrocortisone Cream is a medicine which is used to treat
inflamed sweat rash or Athlete’s Foot.
The cream contains the following ingredients:
Hydrocortisone acetate is a mild ‘topical steroid’ which reduces
inflammation, swelling, redness and itching of the skin.
Miconazole nitrate is an antifungal which works by destroying both the
fungus that causes the infection and some of the associated bacteria
which may also be present.
Sweat rash (candida intertrigo, or ‘thrush’ of the skin folds) is
a sore,
itchy red rash found in areas where the skin rubs together e.g. below
or
between the breasts, underarms, tops of legs or the groin or other
skin
areas.
Athlete’s Foot is a fungal skin infection causing soreness, itching
and
flaking between the toes or on the soles or sides of the feet.
If you have a fungal infection without any symptoms of inflammation,
an antifungal medication without hydrocortisone acetate may be more
appropriate.
Ask your doctor or pharmacist if you are in doubt.
This medicine is for use in adults and children aged 10 years and
over.
2
BEFORE USING THIS MEDICINE
This medicine is suitable for most adults and children but a few
people should n

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Daktacort Hydrocortisone Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole nitrate 2% w/w; Hydrocortisone acetate equivalent to
hydrocortisone 1%
w/w.
Excipients with known effect:
2 mg/g of benzoic acid (E210)
0.052 mg/g of butylhydroxyanisole (E320).
For the full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Cream.
White, homogeneous, odourless cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Athlete’s foot and candidal intertrigo where there are co-existing
symptoms of
inflammation.
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_.
The properties of Daktacort Hydrocortisone Cream indicate it
particularly for the
initial stages of treatment. Once the inflammatory symptoms have
disappeared,
treatment can be continued with Daktarin cream or Daktarin powder.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration
Apply the cream twice a day to the affected area, rubbing in gently
until the
cream has been absorbed by the skin.
The maximum period of treatment is 7 days.
ELDERLY
Natural thinning of the skin occurs in the elderly, hence
corticosteroids should
be used sparingly and for short periods of time.
4.3
CONTRAINDICATIONS
Known
hypersensitivity
to
miconazole
or
other
imidazole
derivatives,
hydrocortisone or to any of the excipients listed in section 6.1.
Tubercular or viral infections of the skin or those caused by
Gram-negative
bacteria.
Daktacort
Hydrocortisone
Cream
should
not
be
used
in
the
following
conditions:
•
If the skin is broken
•
On large areas of skin
•
Used for longer than 7 days
•
To treat cold sores and acne
•
Use on the face, eyes and mucous membranes
•
Children under 10 years of age, unless prescribed by a doctor
•
On the ano-genital region unless prescribed by a doctor
•
To treat ringworm unless prescribed by a doct