Apo-Montelukast

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Montelukast sodium 10.4mg equivalent to montelukast 10 mg

Available from:

Apotex NZ Ltd

INN (International Name):

Montelukast sodium 10.4 mg (equivalent to montelukast 10 mg)

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Montelukast sodium 10.4mg equivalent to montelukast 10 mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Hypromellose Iron oxide red Iron oxide yellow Lactose Magnesium stearate Microcrystalline cellulose Titanium dioxide

Units in package:

Blister pack, Alu/Alu, 4 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Apotex Pharmachem Inc

Therapeutic indications:

APO-Montelukast is indicated in adult and paediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day-time and night-time symptoms and the prevention of exercise-induced bronchospasm

Product summary:

Package - Contents - Shelf Life: Blister pack, Alu/Alu - 4 tablets - 24 months unopened stored at or below 25°C protect from light and moisture. Store in original container - Blister pack, Alu/Alu - 14 tablets - 24 months unopened stored at or below 25°C protect from light and moisture. Store in original container - Blister pack, Alu/Alu - 28 tablets - 24 months unopened stored at or below 25°C protect from light and moisture. Store in original container

Authorization date:

2011-10-18

Patient Information leaflet

APO-MONTELUKAST TABLETS
1
APO-MONTELUKAST TABLETS
_Contains the active ingredient montelukast sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE TAKING YOUR MEDICINE.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU DO NOT UNDERSTAND
ANYTHING OR ARE WORRIED ABOUT
TAKING YOUR MEDICINE.
This leaflet answers some
common questions about
Montelukast.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on
the last page. Some more recent
information on the medicine may
be available. Speak to your
pharmacist or doctor to obtain the
most up to date information on
the medicine.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
this medicine against the benefits
they expect it will have for you.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Montelukast is used to treat:
•
asthma, including preventing
asthma symptoms during the
day and night. It also
prevents the narrowing of
airways triggered by
exercise.
•
seasonal and year-round
allergies, including daytime
and nighttime symptoms,
including nasal congestion,
runny nose, nasal itching,
and sneezing; nasal
congestion upon awakening,
difficulty going to sleep, and
nighttime awakenings;
tearing, itchy, red, and puffy
eyes.
Montelukast can be used in
children 2 years of age and older,
teenagers and adults.
Montelukast tablets are not used
to treat an acute attack of
asthma. If an acute attack
occurs, follow your doctor’s
instructions for that situation.
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

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-MONTELUKAST
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 1
1
PRODUCT NAME
Apo-Montelukast (10mg tablets)
Apo-Montelukast (4mg & 5mg chewable tablets)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains montelukast as sodium equivalent to 4mg, 5mg and
10mg of montelukast.
EXCIPIENT OF KNOWN EFFECT
Apo-Montelukast 10mg tablets contain lactose.
LACTOSE
If you have been told by your doctor that you have intolerance to some
sugars, contact your doctor
before taking this medicinal product.
Apo-Montelukast 4mg and 5mg chewable tablets contain aspartame.
ASPARTAME
Contains a source of phenylalanine. May be harmful for people with
phenylketonuria.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Apo-Montelukast 10 mg: Beige coloured, rounded square shaped, biconvex
film coated tablets, with
engraved “APO” on one side and “M10” on the other side.
Apo-Montelukast 4mg (Chewable Tablets): Pink coloured, oval shaped,
biconvex tablets, engraved with
“APO” on one side and “M 4” on the other side.
Apo-Montelukast 5mg (Chewable Tablets): Pink coloured, round shaped,
biconvex tablets, engraved
with “APO” on one side and “M 5” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Montelukast is indicated in adult and paediatric patients 2 years of
age and older for the prophylaxis
and chronic treatment of asthma, including the prevention of day- and
night-time symptoms and the
prevention of exercise-induced bronchospasm.
Montelukast is indicated in adults and paediatric patients 2 years of
age and older for the relief of
daytime and nighttime symptoms of seasonal allergic rhinitis and
perennial allergic rhinitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Montelukast should be taken once daily. For asthma, the dose should be
taken in the evening. For
allergic rhinitis, the time of administration may be individualised to
suit patient needs.
Patients with both asthma and allergic rhinitis shou