ZATAMIL 0.1% LOTION mometasone furoate 0.1% w/w (1 mg/g) lotion bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

mometasone furoate, Quantity: 1 mg/g

Disponible desde:

Ego Pharmaceuticals Pty Ltd

Designación común internacional (DCI):

mometasone furoate

formulario farmacéutico:

Lotion

Composición:

Excipient Ingredients: industrial methylated spirit; citric acid; propylene glycol; hypromellose; purified water

Vía de administración:

Topical

Unidades en paquete:

1 x 30 mL

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.,ZATAMIL lotion is suitable for use in scalp psoriaris and application to other areas of the body.

Resumen del producto:

Visual Identification: Clear, colourless to straw coloured, slightly thickened solution; Container Type: Bottle; Container Material: HDPE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Registered

Fecha de autorización:

2012-05-10

Información para el usuario

ZATAMIL
_Mometasone furoate 0.1% w/w_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zatamil.
It does not contain all the available
information.
It does not take the place of talking to
your pharmacist or doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Zatamil against
the benefits he expects it will 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 ZATAMIL USED
FOR?
The name of this medicine is
Zatamil. It contains the active
ingredient called mometasone
furoate.
Zatamil is a type of cortisone and
belongs to the group of medicines
called corticosteroids.
There are three dosage forms of
Zatamil: gel, ointment and lotion.
Zatamil lotion is formulated for
easier application to the scalp and
other hairy parts of the body.
ZATAMIL IS USED ON THE SKIN TO
RELIEVE THE REDNESS, SWELLING,
ITCHING AND DISCOMFORT OF MANY
SKIN PROBLEMS SUCH AS:
•
PSORIASIS
(a stubborn skin disorder with
raised, rough, reddened areas
covered with dry, fine silvery
scales)
•
ECZEMA
(an often itchy skin condition
with redness, swelling, oozing of
fluid, crusting which may lead to
scaling)
•
OTHER TYPES OF DERMATITIS
Your doctor, however, may have
prescribed Zatamil for another
purpose. Ask your doctor if you have
any questions about why Zatamil has
been prescribed for you.
Zatamil is available only with a
doctor's prescription.
Zatamil is not addictive.
BEFORE YOU USE
ZATAMIL
_WHEN YOU MUST NOT USE_
_ZATAMIL_
1.
DO NOT USE ZATAMIL IF YOU HAVE
HAD AN ALLERGIC REACTION TO :
•
mometasone furoate
•
any other corticosteroids
•
any of the ingredients in Zatamil
listed at the end of this leaflet
2.
DO NOT USE ZATAMIL:
•
IF YOU HAVE A VIRAL SKIN INFECTION
(SUCH AS COLD SORES, SHINGLES OR
CHICKEN POX)
•
IF YOU HAVE A FUNGAL SKIN
INFECTION (SUCH AS THRUSH, TINEA
OR RINGWORM)
•
ON ACNE
•
FOR INFLAMMATION AROUND THE
MOUTH

Ficha técnica

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