Hydrocortisyl Skin Cream

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCORTISONE

Available from:

Sanofi Malta Limited

ATC code:

D07AA02

INN (International Name):

HYDROCORTISONE

Pharmaceutical form:

CREAM

Composition:

HYDROCORTISONE 1 % (W/W)

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2005-11-24

Patient Information leaflet

674273
*674273*
PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROCORTISYL® SKIN CREAM 1%
_Hydrocortisone _
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
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. 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 of the side effects, talk to your doctor or
pharmacist. This
includes any side effects not listed in this leaflet.
IN THIS LEAFLET:
1. What Hydrocortisyl Skin Cream is and what it is used for
2. What you need to know before you use Hydrocortisyl Skin Cream
3. How to use Hydrocortisyl Skin Cream
4. Possible side effects
5. How to store Hydrocortisyl Skin Cream
6. Contents of the pack and other information
1. WHAT HYDROCRTISYL SKIN CREAM IS AND WHAT IT IS USED FOR
The name of your medicine is Hydrocortisyl Skin Cream 1%.
Hydrocortisyl
Skin Cream contains the active ingredient Hydrocortisone 1% w/w.
• Hydrocortisone belongs to a group of medicines called
corticosteroids. It
works by lowering the production of substances that cause
inflammation.
This helps lower swelling and itching.
Hydrocortisyl Skin Cream can be applied to the skin to treat a variety
of skin
conditions sensitive to corticosteroid treatment such as itching,
eczema,
dermatitis (inflamed skin), including the skin of the outer ear
(otitis externa)
and of your scalp, and rashes due to allergic reactions.
2. BEFORE YOU USE HYDROCORTISYL SKIN CREAM
Do not use this medicine and tell your doctor if:
• You are allergic (hypersensitive) to hydrocortisone or any of the
other
ingredients of Hydrocortisyl Skin Cream (listed in Section 6 below).
Signs
of an allergic reaction include: a rash, swallowing or breathing
problems,
swelling of your lips, face, throat or tongue.
• You have an

Summary of Product characteristics

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hydrocortisyl skin cream 1%.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone (micronised) 1% w/w.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Cream - water miscible base.
A smooth white uniform cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As a prescription only medicine:
In the management of corticosteroid-sensitive superficial dermatoses.
As a pharmacy medicine:
External: Use only for contact dermatitis, irritant dermatitis and
insect bite reactions.
_Route: _
Topical.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS AND CHILDREN: _
Apply one to four times daily, or as directed by a physician. Once
improvement is evident
frequency of application should be gradually reduced.
Do not use on children under 12 years of age without medical
supervision. In this group this
product should be applied sparingly over a small area once or twice a
day for a maximum of
one week.
Page 2 of 5
4.3
CONTRA-INDICATIONS
1.
Use in the presence of untreated infections of bacterial, viral,
tuberculous or fungal
origin.
2.
Use in acne, rosacea or in perioral dermatoses.
3.
Use in plaque psoriasis.
4.
Not for use on the eye, face, in the anogenital region, on broken or
infected skin,
including cold sores, acne and athletes foot.
5.
Hypersensitivity to active ingredient or to excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
Continuous treatment for longer than three weeks should be avoided in
patients under
the age of three years because of the possibility of adrenocortical
suppression and
growth retardation.
2.
Prolonged use of uninterrupted occlusion (including napkins) or use
with extensive
occlusive dressings may suppress adrenocortical function.
3.
Continuous application without interruption will result in local
atrophy of the skin,
striae, and superficial vascular dilatation, particularly on the face.
4.
Prolonged use in the management of acne vulgaris should be avoided.
5.
Use in psoriasis may lead to generalisati