Hydrocortisone 0.5% ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

A A H Pharmaceuticals Ltd

ATC code:

D07AA02

INN (International Name):

Hydrocortisone

Dosage:

5mg/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: 5037563003303

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYDROCORTISONE 0.5% AND 1.0% OINTMENT
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 HYDROCORTISONE OINTMENT IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE OINTMENT
3.
HOW TO USE HYDROCORTISONE OINTMENT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE HYDROCORTISONE OINTMENT
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT HYDROCORTISONE OINTMENT IS AND WHAT IT IS USED FOR
Hydrocortisone belongs to a group of medicines called topical
corticosteroids. These
work by calming the inflammation that occurs during certain skin
conditions or
reactions.
Hydrocortisone ointment may be used for treating various skin
conditions including:

eczema

dermatitis, including intertrigo (irritation between skin folds)

insect bite reactions

inflammation of the external ear (otitis externa)

prurigo nodularis- a long term skin condition where very itchy lumps
appear

neurodermatoses- a long term skin condition where itchy skin becomes
thick due to
scratching

nappy rash, if there is no infection present or existing infection is
being treated with
appropriate antibiotics.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE OINTMENT
DO NOT USE Hydrocortisone ointmentif you:

are ALLERGIC (hypersensitive) to hydrocortisone or any of the other
ingredients of this
medicine

have any OTHER SKIN INFECTION such as athlete’s foot (tinea pedis),
chickenpox
(varicella) or shingles

(Herpes zoster), coldsore

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Efcortelan Ointment 0.5%
Hydrocortisone 0.5% Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone BP 0.5%
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 w