Hydrocortisone 2.5% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

D07AA02

INN (International Name):

Hydrocortisone

Dosage:

25mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000

Patient Information leaflet

Page 1 of 4
90-92/L/m/6a
EFCORTELAN CREAM
hydrocortisone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT EFCORTELAN CREAM IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE EFCORTELAN CREAM
3.
HOW TO USE EFCORTELAN CREAM
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE EFCORTELAN CREAM
6.
FURTHER INFORMATION
1.
WHAT EFCORTELAN CREAM IS AND WHAT IT IS USED FOR
Efcortelan Cream contains a medicine called hydrocortisone. It belongs
to a group of medicines called
steroids. It helps to reduce swelling and irritation.
Efcortelan Cream is used to:

help reduce the redness and itchiness of certain skin problems. These
skin problems include eczema,
dermatitis or insect bites

help reduce inflammation of the outer ear.
2. BEFORE YOU USE HYDROCORTISONE
2. BEFORE YOU USE EFCORTELAN CREAM
DO NOT USE EFCORTELAN CREAM:

if you are allergic (hypersensitive) to hydrocortisone, or any of the
other ingredients of Efcortelan
Cream (listed in Section 6)

to treat any of the following skin problems, it could make them worse:
-
viral infections, such as cold sores, herpes or chicken pox
-
fungal infections, such as ringworm, athletes foot or thrush
-
skin blisters or sores that are caused by an infection.
Do not use if any of the above apply to you. If you are not sure, talk
to your doctor or pharmacist before
using Efcortelan Cream.
TAKE SPECIAL CARE WITH EFCORTELAN CREAM
Check with your doctor or pharmacist before using your medicine if:

you are applying the cream under an airtight dressing, including a
child's nappy. These dressings
make it easier for the active ingredient to pass

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Efcortelan Cream 2.5%
Hydrocortisone 2.5% Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone BP 2.5%
W
/
W.
3
PHARMACEUTICAL FORM
Aqueous Cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hydrocortisone has topical anti-inflammatory activities of value in
the
treatment of a wide variety of dermatological conditions, including
the
following: eczema, including atopic, infantile, discoid and stasis
eczemas:
prurigo nodularis, neurodermatoses, seborrhoeic dermatitis, intertrigo
and
contact sensitivity reactions.
Hydrocortisone preparations can also be used in the management of
insect
bites and otitis externa.
Hydrocortisone 0.5% preparations can be used as continuation therapy
in mild
cases of seborrhoeic or atopic eczema once the acute inflammatory
phase has
passed.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, children and elderly
A small quantity should be applied to the affected area two or three
times
daily.
Hydrocortisone cream is often appropriate for moist or weeping
surfaces, and
Hydrocortisone ointment for dry-lichenified or scaly lesions, but this
is not
invariably so.
For topical application.
4.3
CONTRAINDICATIONS
Skin lesions caused by infection with viruses (e.g. herpes simplex,
chicken pox), fungi
(e.g. candidiasis, tinea) or bacteria (e.g. impetigo).
Hypersensitivity to the preparation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In infants and children, long-term continuous topical therapy should
be avoided where
possible, as adrenal suppression can occur even without occlusion. In
infants, the napkin may
act as an occlusive dressing, and increase absorption. Treatment
should therefore be limited, if
possible, to a maximum of 7 days.
Appropriate antimicrobial therapy should be used whenever treating
inflammatory lesions
which have become infected. Any spread of infection requires
withdrawal of topical
corticosteroid therapy, and systemic administration of antimicrobial
agents.
As with all corticosteroids, pro