Hydrocortisone 1%w/w Ointment

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

HYDROCORTISONE

متاح من:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC رمز:

D07AA02

INN (الاسم الدولي):

HYDROCORTISONE 1 % (W/W)

الشكل الصيدلاني:

OINTMENT

تركيب:

HYDROCORTISONE 1 % (W/W)

نوع الوصفة الطبية :

OTC

المجال العلاجي:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2011-08-24

نشرة المعلومات

148
148
210
210
PATIENT INFORMATION LEAFLET
HYDROCORTISONE 1% W/W OINTMENT
1% HYDROCORTISONE
READ ALL OF THIS LEAFLET BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
This medicine is available without a prescription. However, you still
need to use this product carefully to get the best results
from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen or do not improve
after 7 days
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Hydrocortisone Ointment is and what it is used for
2.
Before you use Hydrocortisone Ointment
3.
How to use Hydrocortisone Ointment
4.
Possible side effects
5.
How to store Hydrocortisone Ointment
6.
Further information
1.
WHAT HYDROCORTISONE OINTMENT IS AND WHAT IT IS USED FOR
Hydrocortisone Ointment is a smooth off-white ointment for application
to the skin only. It contains hydrocortisone which belongs
to a group of medicines called corticosteroids. Hydrocortisone
Ointment is used to reduce inflammation in a variety of
inflammatory skin conditions, such as:
•
mild to moderate eczema
•
dermatitis caused by irritants or allergens
•
insect bite reactions
Hydrocortisone should not be confused with anabolic steroids, used by
some body builders and taken as tablets or injections.
2.
BEFORE YOU USE HYDROCORTISONE OINTMENT
DO NOT USE HYDROCORTISONE OINTMENT:
•
if you are allergic to hydrocortisone or to any of the other
ingredients of Hydrocortisone Ointment
_(see Section 6 _
_ _
_and end of Section 2)._
•
if you have a bacterial infection (e.g. impetigo), viral infection
(e.g. cold sores ‘herpes simplex’, chicken pox) or
fungal infection (e.g. tinea, also called ‘athlete’s foot’,
ringworm or thrush) of the skin.
•
on your face or near your eyes, on the anal or genital region, or on
broken skin.
TAKE SPECIAL CARE WITH HYDROCORTIS

خصائص المنتج

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 1% w/w Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Ointment containing 1% micronised Hydrocortisone in an off-white, soft
paraffin
base.
3.
PHARMACEUTICAL FORM
Ointment for cutaneous use only.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hydrocortisone
has
topical
anti-inflammatory
activity
of
value
in
the
treatment
of
irritant
dermatitis,
contact
allergic
dermatitis,
insect
bite
reactions and mild to moderate eczema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Use sparingly over a small area once/twice a day for a maximum period
of
one week. If the condition has not improved, or worsens, consult your
doctor.
This product should not be recommended for use on children under 10
years
of age without medical supervision.
4.3
CONTRA-INDICATIONS
Bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g.
candidal
or dermatophyte) infections of the skin
.
Hypersensitivity to any of the ingredients.
Additional contraindications for P supply:
Use
on
the
eyes
and
face,
ano-genital region,
broken
or
infected
skin
including cold sores, acne and athlete’s foot.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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 are ineffective in granulomatous conditions
and
other inflammatory reactions involving the deeper regions of the
dermis.
3.
Topical corticosteroids are not generally indicated in psoriasis
excluding
widespread plaque psoriasis provided that warnings are given.
Page 2 of 4
Topical corticosteroids may be hazardous in psoriasis for a number of
reasons
including
rebound
relapses
following
development
of
tolerance,
risk
of
generalised
pustular
psoriasis,
and
local
and
systematic
toxicity
due
to
impaired barrier function of the skin. Careful patient supervision is
important.
Altho