SINGULAIR montelukast 4 mg (as sodium) oral granules sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

montelukast sodium, Quantity: 4.16 mg

Available from:

ORGANON PHARMA PTY LTD

Pharmaceutical form:

Granules

Composition:

Excipient Ingredients: magnesium stearate; mannitol; hyprolose

Administration route:

Oral

Units in package:

28 Sachets, 7 Sachets - sample pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For 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: WHITE, GRANULAR, COARSE, FREE-FLOWING HOMOGENEOUS SOLID.; Container Type: Sachet; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2002-11-13

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