Hydrocortisyl Skin Cream 1%

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCORTISONE

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

D07AA02

INN (International Name):

HYDROCORTISONE 1 % (W/W)

Pharmaceutical form:

CREAM

Composition:

HYDROCORTISONE 1 % (W/W)

Prescription type:

OTC

Therapeutic area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2005-11-24

Patient Information leaflet

710606
*710606*
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.
Always take this medicine exactly as described in this leaflet or as
your
doctor or pharmacist has told you.
– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information or advice.
– 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.
• It is used to treat conditions such as itching, dermatitis
(inflamed skin)
and rashes due to allergic reactions to certain things such as plants,
jewellery, toiletries and deoderants, soaps and detergents and also
insect
bites.
Hydrocortisyl Skin Cream can be applied to the skin to treat a variety
of skin
conditions in adults and children. If the child is under 12 years of
age your
doctor should give you advice on how long and often to use this
product.
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 aller

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Hydrocortisyl Skin Cream 1%.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains hydrocortisone 1% w/w.
Excipients: Contains Chlorocresol 0.1% w/w and Cetostearyl alcohol
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
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 & 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.
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 le