MONTAS 4 (Montelukast Paediatric Chewable Tablets 4 mg)

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

MONTELUKAST SODIUM

Disponible des:

ACCORD HEALTHCARE SDN.BHD.

Designació comuna internacional (DCI):

MONTELUKAST SODIUM

Unidades en paquete:

28 Tablets

Fabricat per:

INTAS PHARMACEUTICALS LIMITED

Informació per a l'usuari

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
MONTAS (MONTELUKAST PAEDIATRIC
CHEWABLE TABLETS)
Montelukast Sodium (4mg, 5mg)
WHAT IS IN THIS LEAFLET
1.
What MONTAS
is
used for
2.
How MONTAS
works
3.
Before you use MONTAS
4.
How to take MONTAS
5.
While
you
are
using
MONTAS
6.
Side effects
7.
Storage and disposal of
MONTAS
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT
MONTAS
IS USED FOR
MONTAS
(montelukast sodium) is used to
treat:
•
Asthma,
including
preventing
your
asthma
symptoms
during
the
day
and
night. MONTAS
also prevents
the
narrowing
of
airways
triggered by exercise.
•
Allergic
rhinitis
(seasonal
and
perennial),
including
daytime
and
nighttime
symptoms:
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.
HOW MONTAS WORKS
MONTAS is
a leukotriene receptor antagonist
that
blocks
substances
called
leukotrienes. Leukotrienes cause
narrowing
and
swelling
of
airways in your lungs. Blocking
leukotrienes
improves
asthma
symptoms
and
helps
prevent
asthma
attacks.
Leukotrienes
also
cause
allergy
symptoms.
Blocking leukotrienes improves
allergic
rhinitis
(seasonal
and
perennial, also known as outdoor
and indoor nasal allergies).
BEFORE
YOU
USE
MONTAS
_- When you must not use it _
_ _
•
Do
not
take
MONTAS
if
you or your child is allergic to
any of its components.
USE IN PREGNANCY
Women
who
are
pregnant
or
intend to become pregnant should
consult their doctor before taking
MONTAS.
USE IN BREAST-FEEDING
It
is
not
known
if
MONTAS
appears
in
breast
milk.
You
should
consult
your
doctor
before taking MONTAS if
you are breast-feeding or intend
to breast-feed.
-
_ Before you start to use it_
_ _
_ _
Tell your doctor (or health care
provider)
about
any
medical
problems or allergies you or your
child has now or has had.
-
_Taking other medicines_
_ _
In
general,
MONTAS
does
not
interfere
with
other
medicines that you or your child
may be

Fitxa tècnica

PACKAGE INSERT
MONTAS
(Montelukast Paediatric Chewable Tablets 4 mg / 5 mg)

NAME AND STRENGTH OF ACTIVE INGREDIENT
MONTAS 4:
Each uncoated tablet contains:
Montelukast Sodium Ph.Eur. 4.16 mg eq. to Montelukast 4 mg
MONTAS 5:
Each uncoated tablet contains:
Montelukast Sodium Ph.Eur. 5.20 mg eq. to Montelukast 5 mg

PRODUCT DESCRIPTION
MONTAS 4: Pink coloured, mottled, oval, biconvex, uncoated tablet,
debossed “M4” on
one side and plain on other side.
MONTAS 5: Pink coloured, mottled, round, biconvex, uncoated tablet,
debossed “M5” on
one side and plain on other side.

PHARMACODYNAMICS & PHARMACOKINETICS
_Pharmacodynamic effects_
Montelukast is a selective and
active leukotriene receptor antagonist.
Montelukast inhibits
bronchoconstriction due to antigen challenge. Montelukast is a
selective leukotriene receptor
antagonist of the cysteinyl leukotriene CysLT 1 receptor. The
cysteinyl leukotrienes (LTC 4,
LTD 4, LTE 4) are products of arachidonic acid metabolism that are
released from various cells,
including mast cells and eosinophils. They bind to cysteinyl
leukotriene receptors (CysLT) found
in
the human airway.
Binding of cysteinyl leukotrienes to leukotriene receptors has been
correlated
with
the
pathophysiology
of
asthma,
including
airway
edema,
smooth
muscle
contraction, and altered cellular activity associated with the
inflammatory process, factors that
contribute to the signs and symptoms of asthma.
It binds to cysteinyl leukotrienes (CysLT) type-1 receptors found in
human airway (smooth
muscle cells and macrophages), which prevents airway edema, smooth
muscle contraction and
other respiratory inflammation. The leukotrienes are also released
from the nasal mucosa after
allergen exposure where montelukast sodium may inhibit symptoms of
allergic rhinitis.
Montelukast
binding
to
the
CysLT1
receptor
is
high-affinity
and
selective,
preferring
the
CysLT1 receptor to other pharmacologically important airway receptors,
such as the prostanoid,
cholinergic, or beta-adrenergic receptor. Montelukast in