Hydrocortisone 0.5% cream

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Hydrocortisone

Διαθέσιμο από:

Teva UK Ltd

Φαρμακολογική κατηγορία (ATC):

D07AA02

INN (Διεθνής Όνομα):

Hydrocortisone

Δοσολογία:

5mg/1gram

Φαρμακοτεχνική μορφή:

Cutaneous cream

Οδός χορήγησης:

Cutaneous

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 13040000; GTIN: 5017007370437

Φύλλο οδηγιών χρήσης

Pharmacode
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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

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 0.5%
m/m
Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone 0.5%
m
/
m
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Aqueous cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eczema and dermatitis of all types including, atopic, infantile,
discoid eczema,
photodermatitis,
otitis
extema,
primary
irritant
and
allergic
dermatitis,
intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite
reaction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For Topical application.
To be applied evenly and sparingly two or three times daily.
_ADULTS AND ELDERLY_: The same dose is used for adults and the
elderly, as
clinical evidence would indicate that no special dosage regimen is
necessary in
the elderly.
_CHILDREN_: Long term therapy should be avoided where possible.
_INFANTS_: Therapy should be limited if possible to a maximum of seven
days.
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
Visual disturbance:
Visual disturbance may be reported with systemic and topical
corticosteroid
use. If a patient presents with symptoms such as blurred vision or
other visual
disturbances, the patient should be considered for referral to an
ophthalmologist for evaluation of possible causes which may include
cataract,
glaucoma or rare diseases such as central serous chorioretinopathy
(CSCR)
which have been reported after use of systemic and topical
corticosteroids.
Remarks on indications
1. There is no good evidence that topical corticosteroids are
efficacious against
immediate (Type 1) allergic skin reactions or short-lived weal and
flare
reactions from other causes.
2. Topical corticosteroids ar