APX-MONTELUKAST montelukast 10 mg (as sodium) film-coated tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

montelukast sodium, Quantity: 10.4 mg

Sẵn có từ:

Accord Healthcare Pty Ltd

INN (Tên quốc tế):

montelukast sodium

Dạng dược phẩm:

Tablet, film coated

Thành phần:

Excipient Ingredients: croscarmellose sodium; hypromellose; iron oxide red; magnesium stearate; hyprolose; iron oxide yellow; macrogol 6000; titanium dioxide; lactose monohydrate; microcrystalline cellulose

Tuyến hành chính:

Oral

Các đơn vị trong gói:

28 Tablets in blister pack

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

-Prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. ,-Symptomatic treatment of seasonal allergic rhinitis.

Tóm tắt sản phẩm:

Visual Identification: Beige coloured rounded square biconvex film coated tablet debossed M10 on one side and plain on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2012-05-17

Tờ rơi thông tin

MONTELUKAST-APOTEX
1
MONTELUKAST APOTEX
_Montelukast sodium _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Montelukast is used to prevent
asthma symptoms, including those
that occur during the day and at
night-time. It also prevents the
narrowing of airways triggered by
exercise.
If you have seasonal allergic rhinitis
(hay fever), montelukast also treats
your allergic rhinitis symptoms.
Montelukast is not used to treat an
acute attack of asthma. If an acute
attack occurs, follow your doctor's
instructions for your reliever
medicine, and keep taking your
montelukast each night or as
prescribed.
As a preventive medicine for asthma,
montelukast can be used alone or in
combination with other preventive
medicines, such as inhaled
corticosteroids.
Asthma is a lung disease and has the
following characteristics:
•
narrowed airways causing
breathing to become difficult
•
inflamed airways, which means
the lining of airways become
swollen
•
sensitive airways that react to
many things, such as cigarette
smoke, pollen, or cold air
Symptoms of asthma include
coughing, wheezing and chest
tightness. Not all people with asthma
wheeze. For some, coughing may be
the only symptom of asthma.
Symptoms often occur during the
night or after exercise.
Seasonal allergic rhinitis (also known
as hay fever) is an allergic response
often caused by airborne pollens
from trees, grasses, and weeds. The
daytime and night-time symptoms of
seasonal allergic rhinitis ty

Đặc tính sản phẩm

1
Montelukast Apotex v2 11.21
AUSTRALIAN PRODUCT INFORMATION –
MONTELUKAST APOTEX (MONTELUKAST SODIUM)
1
NAME OF THE MEDICINE
Montelukast sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4 mg chewable tablet contains 4.16 mg montelukast sodium, which
is equivalent to
4.0 mg of montelukast.
Each 5 mg chewable tablet contains 5.2 mg montelukast sodium, which is
equivalent to 5.0 mg
of montelukast
Each 10 mg film-coated tablet contains 10.4 mg montelukast sodium,
which is equivalent to
10.0 mg of montelukast.
Excipients with known effects:
•
Aspartame (4 mg and 5 mg chewable tablets only).
•
Lactose monohydrate (10 mg film-coated tablets only).
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
4 mg chewable tablets: Pink coloured, mottled, oval, biconvex,
uncoated tablet, debossed
“M4” on one side and plain on other side.
5 mg chewable tablets: Pink coloured, mottled, round, biconvex,
uncoated tablet, debossed
“M5” on one side and plain on other side.
10 mg film-coated tablets: Beige coloured, rounded square, biconvex,
film coated tablet
debossed “M10” on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis and treatment of chronic asthma in adults and children 2
years of age and older.
Symptomatic treatment of seasonal allergic rhinitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
ASTHMA AND/OR SEASONAL ALLERGIC RHINITIS
Montelukast Tablets should be taken once daily.
For asthma, the dose should be taken in the evening.
For seasonal allergic rhinitis, the time of administration may be
individualised to suit patient
needs.
Patients with both asthma and seasonal allergic rhinitis should take
only one tablet daily in
the evening.
2
Montelukast Apotex v2 11.21
Adults 15 Years of Age and Older
The dosage for adults 15 years of age and older is one 10 mg tablet
daily.
Paediatric Patients 6 to 14 Years of Age
The dosage for paediatric patients 6 to 14 years of age is one 5 mg
chewable tablet daily.
Paediatric Patients 2