Sigmacort Cream 1%

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrocortisone acetate, Quantity: 10 mg/g

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Hydrocortisone acetate

Pharmaceutical form:

Cream

Composition:

Excipient Ingredients: liquid paraffin; purified water; chlorocresol; cetostearyl alcohol; cetomacrogol 1000; white soft paraffin

Administration route:

Topical

Units in package:

50g, 30g

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine, (S3) Pharmacist Only Medicine

Therapeutic indications:

Topical corticosteroid therapy for non-infective inflammatory conditions of the skin eg. eczema, dermatitis.

Product summary:

Visual Identification: A soft white cream with an odour faintly of chlorocresol.; Container Type: Tube; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1991-10-14

Patient Information leaflet

SIGMACORT Cream and Ointment- Consumer Medicine Information
Page 1 of 3
SIGMACORT 1% CREAM AND OINTMENT
hydrocortisone acetate
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SIGMACORT. It
does not contain all the available
information. It does not take place
of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of using SIGMACORT
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IS SIGMACORT
The name of your medicine is
SIGMACORT. It contains the active
ingredient called hydrocortisone
acetate.
It is available as a cream and an
ointment.
SIGMACORT is a type of cortisone
and belongs to the group of
medicines called corticosteroids.
It is a topical corticosteroid therapy
for non-infective inflammatory
conditions of the skin e.g. eczema,
dermatitis. It is used to relieve the
redness, swelling, itching and other
discomforts of the skin.
Your doctor however, may have
prescribed SIGMACORT for another
purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT
WHY SIGMACORT HAS BEEN
PRESCRIBED FOR YOU.
A doctor's prescription is required
for the 50 gram tube of SIGMACORT
cream or ointment.
The 30 gram tube can be purchased
without a doctor’s prescription.
BEFORE YOU USE IT
When you must not use it
DO NOT USE SIGMACORT IF YOU
HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
SIGMACORT or hydrocortisone
acetate.
•
Any of the ingredients in
SIGMACORT listed at the end of
this leaflet.
DO NOT USE SIGMACORT IF YOU
HAVE:
•
A viral skin infection (such as
herpes simplex, cold sores,
shingles or chicken pox)
•
A fungal skin infection (such as
thrush, tinea or ringworm)
•
Tuberculous condition of the skin
•
Vaccinia (cowpox: a viral disease
passed from cattle)
•
Varicella (a rare form of chicken
pox).
SIGMACORT should not be used

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
SIGMACORT 1% (HYDROCORTISONE ACETATE)
CREAM & OINTMENT
1
NAME OF THE MEDICINE
Hydrocortisone acetate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SIGMACORT 1% CREAM contains 10 mg/g (1.0% w/w) microfine
hydrocortisone acetate in a
water miscible, lanolin free cetomacrogol base.
SIGMACORT 1% OINTMENT contains 10 mg/g (1.0% w/w) microfine
hydrocortisone acetate in a
paraffin base.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SIGMACORT 1% CREAM is a soft white cream with an odour faintly of
chlorocresol.
SIGMACORT 1% OINTMENT is a soft, yellowish white ointment with a faint
odour of paraffin and
lanolin.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Topical corticosteroid therapy for non-infective inflammatory
conditions of the skin e.g.
eczema, dermatitis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Apply a thin smear to affected areas 2 - 4 times daily. Reduce the
number of applications as
the disorder subsides. Occlusive dressings are not necessary unless
advised by your
doctor.
4.3
C
ONTRAINDICATIONS
•
Tuberculous and fungal conditions of the skin, acute Herpes simplex,
vaccinia, varicella
and all viral infections.
•
Hypersensitivity to any component of the cream or ointment.
•
Not to be used in the eye.
•
Topical steroids should not be used in patients with markedly impaired
circulation since
skin ulceration has occurred in these patients following the use of
corticosteroids.
•
Topical steroid should be used with caution and occlusive dressings
should not be used
in patients with primary skin infections.
2
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.
If irritation develops Sigmacort should be discontinued and
alternative therapy instituted.
Prolonged and heavy doses of hydrocortisone may have an
immunosuppressant effect and
thus decrease resistance to infection as well as mask signs of it. If
infection of the skin is
present suitable antifungal or antibacterial agents should