Hydrocortisone 2.5% cream

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Hydrocortisone

MAH:

Teva UK Ltd

ATC_code:

D07AA02

INN:

Hydrocortisone

dosage:

25mg/1gram

pharmaceutical_form:

Cutaneous cream

administration_route:

Cutaneous

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 13040000; GTIN: 5017007598114

PIL

REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard, or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.
HOW TO STORE HYDROCORTISONE CREAM
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
Hydrocortisone Cream should be stored below 25ºC
and not frozen.
Do not use Hydrocortisone Cream after the expiry
date which is stated on the carton or on the tube
after EXP. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.
CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT HYDROCORTISONE CREAM CONTAINS:
•
The active substance is hydrocortisone
•
The other ingredients are white soft paraffin,
cetomacrogol emulsifying wax, liquid paraffin,
chlorocresol, and purified water.
WHAT HYDROCORTISONE CREAM LOOKS LIKE AND CONTENTS
OF THE PACK:
•
Hydrocortisone 0.5 %, 1 %, and 2.5 % Cream is an
aqueous cream
•
Hydrocortisone 0.5 %, 1 %, and 2.5 % Cream is
available in 15 g tubes. Hydrocortisone 1 % Cream
is also available in 30 g and 50 g tubes.
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Marketing Authorisation holder: TEVA UK Limited,
Eastbourne, BN22 9AG England and company
responsible for manufacture: Teva Pharmaceutical
Works Private Limited, Pallagi Street 13, Debrecen,
H 4042, Hungary
THIS LEAFLET WAS LAST REVISED: JUNE 2019
PL 00289/0753-0755
•
are using this cream under occlusive dressing that
can considerably increase the absorption of this
cream.
Caution should be taken to keep away from the eyes.
Contact your doctor if you experience blurred vision
or other visual dist

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 2.5% m/m Cream.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone 2.5 %
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