Hydrocortisone 0.5% 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:

5mg/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

Pharmacode
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2.
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4.
5.
6.
1.
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Details
HYDROCORTISONE 0.5% & 1% CREAM PIL - UK
Black
BBBA6623
C Fox
16/10/2019
105 x 171
7pt
Teva Jakarta
16/10/2019
1710/2019
1
Version 2
01.11.2017
HYDROCORTISONE 0.5% AND 1.0% CREAM
BBBA6623
_Continued over page_
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 CREAM IS AND WHAT
IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU USE
HYDROCORTISONE CREAM
3
HOW TO USE HYDROCORTISONE CREAM
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE HYDROCORTISONE CREAM
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT HYDROCORTISONE CREAM 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 cream may be used for treating various
skin conditions including:
• eczema
•
dermatitis, including intertrigo (irritation between
skin folds)
•
insect bite reactions
•
inflammation of the external e

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone Cream BP 0.5%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 0.50% w/w Hydrocortisone Ph. Eur.
Excipients with known effect: cetostearyl alcohol and chlorocresol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A white cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hydrocortisone
has
topical
anti-inflammatory
activities
of
value
in
the
treatment of various dermatological conditions including:
Eczema- atopic, infantile, discoid or stasis
Dermatitis- primary irritant, contact allergic, photo or seborrhoeic
Insect bite reactions
Prurigo nodularis
Neurodermatoses
Otitis externa
Intertrigo
Napkin rash, where concurrent infection is excluded or being addressed
Hydrocortisone Cream 0.5% 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
_Posology _
Adults (including elderly)
Gently apply a thin layer of cream to the affected area two or three
times daily.
Children and infants
Gently apply a thin layer of cream to the affected area two or three
times daily.
Avoid prolonged use. In infants, therapy should be limited to five to
seven
days.
Hydrocortisone
cream
is
usually
suitable
for
moist
or
weeping
surfaces,
whereas the ointment formulation should be considered for dry, scaly
or
lichenified conditions.
_Method of Administration _
For topical application
4.3
CONTRAINDICATIONS
Hypersensitivity to hydrocortisone or to any of the excipients listed
in section
6.1 or on untreated bacterial (e.g. impetigo), fungal (e.g. candida or
dermatophyte) or viral (e.g. herpes simplex) infections of the skin,
infected
lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of an occlusive dressing can considerably increase the degree
of
systemic absorption. If the treatment continues longer than two weeks,
the risk
of systemic side effec