MONTELUKAST SANDOZ 4 montelukast 4 mg (as sodium) chewable tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

montelukast sodium, Quantity: 4.16 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

montelukast sodium

Pharmaceutical form:

Tablet, chewable

Composition:

Excipient Ingredients: microcrystalline cellulose; iron oxide red; magnesium stearate; mannitol; croscarmellose sodium; aspartame; Flavour

Administration route:

Oral

Units in package:

4 Tablets in blister pack, 28 Tablets in blister pack, 14 Tablets in blister pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Pink colored mottled oval biconvex uncoated tablet debossed M4 on one side and plain on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-05-17

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
MONTELUKAST SANDOZ
(MONTELUKAST SODIUM) CHEWABLE AND FILM-COATED TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
MONTELUKAST SANDOZ. 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
montelukast 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 MONTELUKAST
SANDOZ IS USED FOR
MONTELUKAST SANDOZ 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 SANDOZ also
treats your allergic rhinitis
symptoms.
It can be used in children 2
years of age and older,
teenagers and adults.
MONTELUKAST SANDOZ 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 SANDOZ each
night or as prescribed.
As a preventive medicine for
asthma, MONTELUKAST
SANDOZ can be used alone or
in combination with other
preventive medicines, such as
inhaled corticosteroids. Your
doctor may reduce your dose of
inhaled corticosteroid while you
are taking MONTELUKAST
SANDOZ.
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.
For further information about
as

Summary of Product characteristics

1
V3
AUSTRALIAN PRODUCT INFORMATION –
MONTELUKAST SANDOZ
® (MONTELUKAST SODIUM) TABLETS
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 effect: Aspartame in the 4 mg and 5 mg tablets
only.
Lactose in the 10 mg 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 tablets: Beige coloured, rounded square, biconvex, film coated
tablet debossed “M10” on one
side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
ASTHMA AND/OR SEASONAL ALLERGIC RHINITIS
2
V3
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
individualized to suit patient needs.
Patients with both asthma and seasonal allergic rhinitis should take
only one tablet daily in the
evening.
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 TO 5 YEARS OF AGE
The dosage for paediatric patients 2 to 5 years of age is one 4