Efcortelan 2.5% ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

Chemidex Pharma Ltd

ATC code:

D07AA02

INN (International Name):

Hydrocortisone

Dosage:

25mg/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000

Patient Information leaflet

Please turn over the page
93-95/L/m/6a
93-95/L/m/6a
For a child

The smaller the child the less you will need to
use.

A child of 4 years needs about a third of the
adult amount.

A course of treatment for a child should not
normally last more than 7 days - unless your
doctor has told you to use it for longer.
If you apply Hydrocortisone Ointment to your
face
You should only apply the ointment to your face
if your doctor tells you to. The ointment should
not be used for too long as the skin on your face
thins easily.
If you use more Hydrocortisone Ointment
than you should
If, by mistake on a few occasions you use more
than you should, do not worry. If you apply a lot
or if a lot is accidentally swallowed, it could make
you ill. Talk to your doctor or go to hospital as
soon as possible.
If you forget to use Hydrocortisone Ointment
If you forget to apply your ointment, apply it as
soon as you remember. If it is close to the time
you are next meant to apply it, wait until this
time.
If you stop using Hydrocortisone Ointment
If you use Hydrocortisone Ointment regularly
make sure you talk to your doctor before you
stop using it.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Hydrocortisone Ointment can
cause side effects, although not everybody gets
them.
STOP using Hydrocortisone Ointment and
tell your doctor as soon as possible if:

you find that your skin condition gets worse or
becomes swollen during treatment. You may
be allergic to the ointment, have an infection
or need other treatment.
Other side effects you may notice when
using Hydrocortisone Ointment include:

irritation or itching where the ointment is
applied

increased hair growth and changes in skin
colour.
Side effects if you use Hydrocortisone Ointment
for a long time, you use a lot each time you
apply it, or you apply it under an airtight dressing
or a nappy:

thinning of your skin and it may also damage
more easily

weight gain, roundin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Efcortelan Ointment 2.5%
Hydrocortisone 2.5% Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone BP 2.5% w/w.
3
PHARMACEUTICAL FORM
Ointment.
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.
Route of Administration
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 seven 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 wit