ARISTOCORT 0.02% OINTMENT triamcinolone acetonide 0.2mg/g tube

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

triamcinolone acetonide, Quantity: 0.2 mg/g

Saatavilla:

Aspen Pharmacare Australia Pty Ltd

INN (Kansainvälinen yleisnimi):

Triamcinolone acetonide

Lääkemuoto:

Ointment

Koostumus:

Excipient Ingredients: white soft paraffin

Antoreitti:

Topical

Kpl paketissa:

2g sample pack, 100g

luokka:

Medicine Registered

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

INDICATIONS AS AT 22 October 1998: In the treatment of the following dermatoses: atopic dermatitis, eczematous dermatitis, nummular eczema, contact dermatitis, anal and vulval pruritus, otitis externa, seborrhoeic dermatitis, exzematised psoriasis, neurodermatitis.

Tuoteyhteenveto:

Visual Identification: Off-white, smooth, homogeneous, opaque ointment, free of visible contamination.; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

1991-09-09

Pakkausseloste

ARISTOCORT
1
ARISTOCORT CREAM AND OINTMENT
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ARISTOCORT?
ARISTOCORT contains the active ingredient triamcinolone acetonide.
ARISTOCORT is used on the skin to relieve the redness,
swelling, itching and discomfort of many skin problems.
For more information, see Section 1. Why am I using ARISTOCORT? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ARISTOCORT?
Do not use if you have ever had an allergic reaction to ARISTOCORT or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ARISTOCORT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ARISTOCORT and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ARISTOCORT?
ARISTOCORT is applied to the affected area three or four times daily.
More instructions can be found in Section 4. How do I use ARISTOCORT?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ARISTOCORT?
THINGS YOU SHOULD DO
•
Remind any doctor or pharmacist you visit that you are using
ARISTOCORT
•
Tell your doctor if you feel that ARISTOCORT is not helping your
condition or you have not
used it exactly as prescribed.
THINGS YOU SHOULD NOT DO
•
Do not use ARISTOCORT just before having a bath, shower or going
swimming.
•
Do not use this medicine under dressings or on large areas of skin
•
Do not use ARISTOCORT in or near the eyes.
LOOKING AFTER YOUR MEDICINE
•
Store below 25°C. Do not refrigerate.
For more information, see Section 5. What should I know while using
ARISTOCORT? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
All medicines can have side effects. If

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION
ARISTOCORT (TRIAMCINOLONE ACETONIDE)
CREAM AND OINTMENT
1
NAME OF THE MEDICINE
Triamcinolone acetonide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ARISTOCORT cream and ointment contain 0.02% w/w triamcinolone
acetonide.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ARISTOCORT cream is a smooth, white, opaque homogenous cream free from
visible
contamination.
ARISTOCORT ointment is an off-white, smooth, homogeneous, opaque
ointment free of
visible contamination.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
In the treatment of the following dermatoses: atopic dermatitis,
eczematous dermatitis,
nummular eczema, contact dermatitis, anal and vulval pruritus, otitis
externa, seborrhoeic
dermatitis, eczematised psoriasis, neurodermatitis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Apply in small quantities to the affected area three or four times
daily. Some cases of
eczematised psoriasis may be treated more effectively by the
application of ARISTOCORT
under an occlusive nonpermeable dressing.
4.3
C
ONTRAINDICATIONS
•
Tuberculosis of the skin, fungal infections and viral diseases of the
skin (Herpes simplex,
chicken-pox and baccinia).
•
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.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
2
FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.
If irritation develops, ARISTOCORT should be discontinued and
alternative therapy instituted.
Prolonged and heavy doses of triamcinolone acetonide 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 anti