CORTIC-DS 1% hydrocortisone acetate 10mg/g ointment tube

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

hydrocortisone acetate, Quantity: 10 mg/g

Διαθέσιμο από:

Aspen Pharmacare Australia Pty Ltd

INN (Διεθνής Όνομα):

Hydrocortisone acetate

Φαρμακοτεχνική μορφή:

Ointment

Σύνθεση:

Excipient Ingredients: white soft paraffin; hard paraffin; Wool fat; liquid paraffin

Οδός χορήγησης:

Topical

Μονάδες σε πακέτο:

50g, 30g

Τρόπος διάθεσης:

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

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Visual Identification: A soft, yellowish white ointment with an odour faintly of paraffin and lanolin.; Container Type: Tube; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2003-01-07

Φύλλο οδηγιών χρήσης

CORTIC-DS- Consumer Medicine Information
Page 1 of 3
CORTIC-DS 1% CREAM AND OINTMENT
_hydrocortisone acetate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CORTIC-DS.
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 CORTIC-DS
against the benefits this medicine is
expected to have for you.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CORTIC-DS IS USED
FOR
The name of your medicine is
CORTIC-DS. It contains the active
ingredient called hydrocortisone
acetate.
It is available as a cream and an
ointment.
CORTIC-DS is a type of cortisone
and belongs to the group of
medicines called corticosteroids.
CORTIC-DS 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.
ASK YOUR DOCTOR (OR PHARMACIST) IF
YOU HAVE ANY QUESTIONS ABOUT WHY
CORTIC-DS HAS BEEN PRESCRIBED
FOR YOU.
Your doctor, however, may have
prescribed CORTIC-DS for another
purpose.
A doctor's prescription is required
for the 50 gram tube of CORTIC-
DS cream or ointment.
The 30 gram tube of CORTIC-DS
cream or ointment can be purchased
without a doctor’s prescription.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE CORTIC-DS IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
TO:
•
CORTIC-DS or hydrocortisone
acetate.
•
Any of the ingredients in
CORTIC-DS listed at the end of
this leaflet.
DO NOT USE CORTIC-DS 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 chi

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION
CORTIC-DS 1% (HYDROCORTISONE ACETATE)
CREAM & OINTMENT
1
NAME OF THE MEDICINE
Hydrocortisone acetate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CORTIC-DS 1% CREAM contains 10 mg/g (1.0% w/w) microfine
hydrocortisone acetate in a
water miscible, lanolin free cetomacrogol base. hydrocortisone
acetate.
CORTIC-DS 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
CORTIC-DS 1% CREAM is a soft white cream with an odour faintly of
chlorocresol.
CORTIC-DS 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 noninfective 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 Cortic-DS 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 antib