SINGULAIR Montelukast (as sodium) 5 mg chewable tablet blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

montelukast sodium, Quantity: 5.2 mg (Equivalent: montelukast, Qty 5 mg)

Available from:

ORGANON PHARMA PTY LTD

Pharmaceutical form:

Tablet, chewable

Composition:

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

Administration route:

Oral

Units in package:

28 tablets, 4 tablets - sample pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prophylaxis and treatment of chronic asthma in adults and children over two years. Symptomatic treatment of seasonal allergic rhinitis

Product summary:

Visual Identification: A pink biconvex round chewable tablet engraved with SINGULAIR on one side and MSD 275 on the other; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1998-05-11

Patient Information leaflet

SINGULAIR
®
_Montelukast sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SINGULAIR. 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 SINGULAIR
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 SINGULAIR IS
USED FOR
SINGULAIR 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), SINGULAIR also treats
your allergic rhinitis symptoms.
It can be used in children 2 years of
age and older, teenagers and adults.
SINGULAIR tablets are 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
SINGULAIR each night or as
prescribed.
As a preventive medicine for asthma,
SINGULAIR 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
SINGULAIR.
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
asthma, contact the Asthma
Foundation in your state on 1800 645
130, or www.asthmaaustralia.org.au
Seasonal

Summary of Product characteristics

S-WPC-MK0476-MF-112018
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
SINGULAIR
®
(MONTELUKAST SODIUM)
TABLETS AND GRANULES
1
NAME OF THE MEDICINE
Montelukast sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg film-coated tablet contains 10.4 mg montelukast sodium,
which is equivalent to
10.0 mg of montelukast, the free acid.
Excipients with known effects:
-
lactose monohydrate
Each 5 mg chewable tablet contains 5.2 mg montelukast sodium, which is
equivalent to 5.0
mg of montelukast, the free acid.
Each 4 mg chewable tablet contains 4.16 mg of montelukast sodium,
which is equivalent to
4.0 mg of montelukast, the free acid.
Excipients with known effects:
-
aspartame
Each packet of 4 mg oral granules contains 4.16 mg of montelukast
sodium, which is
equivalent to 4.0 mg of montelukast, the free acid.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
10 mg film-coated tablet - A beige biconvex rounded square film-coated
tablet engraved with
SINGULAIR on one side and MSD 117 on the other.
5 mg chewable tablet - A pink biconvex round chewable tablet engraved
with SINGULAIR on
one side and MSD 275 on the other.
4 mg chewable tablet - A pink, oval, biconvex chewable tablet with
SINGULAIR debossed on
one side and MSD 711 on the other.
4 mg oral granules - Coarse, white free-flowing granules sealed in a
foil packet.
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.
S-WPC-MK0476-MF-112018
Page 2 of 18
4.2
DOSE AND METHOD OF ADMINISTRATION
ASTHMA AND/OR SEASONAL ALLERGIC RHINITIS
SINGULAIR 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.
ADULTS 15 YEARS OF AGE AND OLDER
The dosage for adults 15