Hydrocortisone 1% ointment

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Hydrocortisone

제공처:

Pinewood Healthcare

ATC 코드:

D07AA02

INN (International Name):

Hydrocortisone

복용량:

10mg/1gram

약제 형태:

Cutaneous ointment

관리 경로:

Cutaneous

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 13040000; GTIN: 5099186003818 5099186003825 5099186003924

환자 정보 전단

Dimensions:
Artwork
Code:
Date
Version:
2
23LF01885PW
14/10/21
260 x 148 mm
Font:
Helvetica - 9pt - 8pt
Printing:
Non-Printing:
Other information:
Previous code - 23LF01574PW
Safety Updates Aug-21
Keyline change from 210 x 148mm --> 260 x 148mm due to additional text
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Package leaflet: Information for the user
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 talk to a doctor if you do not feel better or if you feel
worse after 7 days.
• 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 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. What you need to know before you use Hydrocortisone Ointment
Do not use Hydrocortisone Ointment:
• if you are allergic to hydrocortisone or any of the other
ingredients of

제품 특성 요약

1.
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 1% w/w Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 gram of the ointment contains 10 mg of Hydrocortisone (i.e. 1
%w/w).
Excipient with known effect
Each 1 gram of the ointment contains 100 mg (10 %w/w) of wool fat.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ointment for cutaneous use only
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
Posology
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.
Method of administration
For cutaneous use
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 the active substance or to any of the excipients
listed in section
6.1.
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.
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 systema