ZATAMIL 0.1% HYDROGEL mometasone furoate 0.1% w/w (1 mg/g) gel tube

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

mometasone furoate, Quantity: 1 mg/g

Доступно од:

Ego Pharmaceuticals Pty Ltd

INN (Међународно име):

mometasone furoate

Фармацеутски облик:

Gel

Састав:

Excipient Ingredients: hexylene glycol; citric acid; hypromellose; purified water

Пут администрације:

Topical

Јединице у пакету:

1 x 5 g, 15g, 1 x 45 g

Тип рецептора:

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

Терапеутске индикације:

For the short term (up to four continuous weeks) relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as psoriasis and atopic dermatitis.

Резиме производа:

Visual Identification: Soft, clear, colourless to straw-coloured gel; Container Type: Tube; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус ауторизације:

Registered

Датум одобрења:

2012-05-10

Информативни летак

ZATAMIL
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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 ZATAMIL?
Zatamil contains the active ingredient mometasone furoate. Zatamil is
used on the skin to relive the redness, swelling, itching and
discomfort of many skin problems such as psoriasis, eczema and other
types of dermatitis.
For more information, see Section 1. Why am I using Zatamil? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ZATAMIL?
Do not use if you have ever had an allergic reaction to mometasone
furoate or any of the ingredients listed in Section 7. Product
details.
Do not use if you have a viral skin condition, a fungal skin
condition, on acne, inflammation around the mouth, a skin condition
with
ulcers, or your have tuberculosis of the skin.
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
Zatamil? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Zatamil and affect how it works.
Refer to Section 3. What if I am taking other medicines? in the full
CMI.
4.
HOW DO I USE ZATAMIL?
•
Apply a light film of Zatamil Hydrogel or Ointment or a few drops of
Zatamil Lotion to the affected area once a day and rub in
lightly.
More instructions can be found in Section 4. How do I use Zatamil? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ZATAMIL?
THINGS YOU
SHOULD DO
•
If your condition does not improved after one week of using Zatamil
daily, tell your pharmacist or doctor.
•
Tell your doctor if your skin condition worsens or becomes infected.
THINGS YOU
SHOULD NOT DO
•
Do not use Zatamil under dressings or on large areas of skin,
particularly in infants and children, unless
your doctor tells you.
•
Do not use Zatamil under a nappy or under plastic pants, in the case

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION – ZATAMIL
(MOMETASONE FUROATE) GEL, LOTION, OINTMENT
1
NAME OF THE MEDICINE
Mometasone furoate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mometasone furoate 0.1% (1mg/g).
Mometasone furoate is a white to off-white powder which is practically
insoluble in water,
soluble in acetone and in methylene chloride, slightly soluble in
ethanol (96 per cent).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Zatamil Hydrogel is a clear, colourless to straw-coloured gel.
Zatamil Ointment is an opaque white to off-white ointment.
Zatamil Lotion is a clear, colourless to straw-coloured lotion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Short term (up to four continuous weeks) relief of inflammation and
pruritic manifestations of
corticosteroid-responsive dermatoses, such as psoriasis and atopic
dermatitis.
Zatamil Lotion is suitable for use in scalp psoriasis and applications
to other areas of the
body.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Apply a thin film of the ointment or gel to the affected skin once
daily. For Zatamil Lotion few
drops should be applied to the affected skin areas including scalp
sites once daily; massage
gently and thoroughly until the medication disappears.
4.3
C
ONTRAINDICATIONS
Hypersensitivity to mometasone furoate or to other corticosteroids.
As with other corticosteroids, Zatamil is contraindicated in most
viral infections of the skin,
tuberculosis, acne rosacea, perioral dermatitis, fungal skin
infections and ulcerative
conditions.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only. Avoid contact with eyes.
2
If irritation or sensitisation develops, treatment should be
discontinued and appropriate
therapy instituted.
In the presence of an infection, an antibacterial or antifungal agent,
as appropriate should be
added to the treatment regimen. If the infection does not resolve
promptly, corticosteroid
therapy should be discontinued until the infection is controlled.
As with all topical corticoste