Hydrocortisyl Skin Cream 1%

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydrocortisone

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

D07AA; D07AA02

INN (International Name):

Hydrocortisone

Dosage:

1.0 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Corticosteroids, weak (group I); hydrocortisone

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

753892
*753892*
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 any kind of infection, this includes infections caused by
viruses, bacteria or fungus or if you are

Summary of Product characteristics

Health Products Regulatory Authority
04 November 2021
CRN00C4MC
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisyl Skin Cream 1%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone (micronized) 1% w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cream
A smooth white uniform cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a prescription only medicine:
This medicinal product is indicated in the management of
corticosteroid-sensitive superficial dermatoses.
As a pharmacy medicine:
This medicinal product is indicated for 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 two times daily, or as directed by a physician. Once
improvement is evident frequency of application should be
gradually reduced.
Hydrocortisyl should not be used 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 CONTRAINDICATIONS
1.
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1
2.
In the presence of untreated infections of bacterial, viral,
tuberculous or fungal origin.
3.
In acne rosacea or in perioral dermatoses
4.
In plaque psoriasis
5.
Not for use on the eye, face, in the anogenital region, on broken or
infected skin, including cold sores, acne and
athlete's foot.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hydrocortisyl is for external use only. Do not apply to mucosal
surfaces. Avoid contact with eyes.
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.
Health Products Regulatory Authority
04 November 2021
CRN00C4MC
Page 2 of 4
Prolonged use of uninterrupted occlusion (including napkins) or use
with extensive occlusive dressings may supp