MONTELAIR 5 montelukast 5 mg (as sodium) chewable tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

montelukast sodium, Quantity: 5.2 mg

Tilgjengelig fra:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

montelukast sodium

Legemiddelform:

Tablet, chewable

Sammensetning:

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

Administreringsrute:

Oral

Enheter i pakken:

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

Klasse:

Medicine Registered

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

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

Produkt oppsummering:

Visual Identification: Pink colored mottled round biconvex uncoated tablet debossed M5 on one side and plain on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2012-05-17

Informasjon til brukeren

_Montelukast AN tablets – Consumer Medicine Information _
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_Doc ID: 78.116.AN.M.1.0 _
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_Page 1 _
MONTELUKAST AN TABLETS
_montelukast sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Montelukast
AN.
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
AN
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 AN
IS USED FOR
Montelukast
AN
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 AN also treats your
allergic rhinitis symptoms.
It
can
be
used
in
children
2
years
of
age
and
older,
teenagers and adults.
Montelukast AN 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
Montelukast
AN
each night or as prescribed.
As
a
preventive
medicine
for
asthma, Montelukast AN 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
AN.
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

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION – MONTELAIR 4, 5 & 10
(MONTELUKAST SODIUM) TABLETS
1
NAME OF THE MEDICINE
Montelukast (as sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each MONTELAIR 10 film-coated tablet contains 10.4 mg montelukast
sodium, which is equivalent
to 10.0 mg of montelukast.
Each MONTELAIR 5 chewable tablet contains 5.2 mg montelukast sodium,
which is equivalent to 5.0
mg of montelukast.
Each MONTELAIR 4 chewable tablet contains 4.16 mg montelukast sodium,
which is equivalent to 4.0
mg of montelukast.
Excipients with known effect:
Aspartame and mannitol in the 4 mg and 5 mg tablets only.
Lactose monohydrate in the 10 mg tablets only.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
MONTELAIR 4 tablets - Pink coloured, mottled, oval, biconvex, uncoated
tablet, debossed “M4” on
one side and plain on other side.
MONTELAIR 5 tablets - Pink coloured, mottled, round, biconvex,
uncoated tablet, debossed “M5” on
one side and plain on other side.
MONTELAIR 10 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.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
ASTHMA AND/OR SEASONAL ALLERGIC RHINITIS
MONTELAIR 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 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 paediatr