Monkasta 10 mg film-coated tablets

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

MONTELUKAST SODIUM

Verfügbar ab:

PAHANG PHARMACY SDN. BHD.

INN (Internationale Bezeichnung):

MONTELUKAST SODIUM

Einheiten im Paket:

28 mcg/mL

Hergestellt von:

KRKA, d.d., Novo mesto

Gebrauchsinformation

MONKASTA FILM-COATED TABLETS
Montelukast (10mg)
_Consumer Medication Information Leaflet (RiMUP)_
_ _
1
WHAT IS IN THIS LEAFLET
1.
What _Monkasta _is used for
2.
How _Monkasta_ works
3.
Before you use _Monkasta_
4.
How to use _Monkasta_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Monkasta_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _MONKASTA_ IS USED FOR
Monkasta is used for the treatment of
adult patients and adolescents, aged 15
years and older with asthma, who are
not
adequately
controlled
on
their
asthma medications and need additional
therapy.
For patients with asthma and seasonal
allergies,
Monkasta
also
treats
your
seasonal allergy symptoms.
Monkasta
also
helps
prevent
asthma
symptoms
in
adult
patients
and
adolescents, aged 15 years and older,
which are triggered by exercise.
HOW _MONKASTA_ WORKS
The
active
ingredient
in
Monkasta
10 mg tablets is montelukast, which is a
leukotriene
receptor
antagonist.
It
blocks naturally occurring chemicals in
the
lungs
called
leukotrienes
which
cause
narrowing
of
the
airways
and
inflammation in the lungs, which can
lead to asthma symptoms. Leukotrienes
also
contribute
to
the
symptoms
of
allergy. Blocking leukotrienes reduces
the symptoms of seasonal allergy (also
known as seasonal allergic rhinitis or
hay fever).
BEFORE YOU USE _MONKASTA _
-
_When you must not use it _
Do
not
take
Monkasta
if
you
are
allergic (hypersensitive) to montelukast
or
any
of
the
other
ingredients
of
Monkasta.
Monkasta
10
mg
tablets
are
not
recommended for use in children under
15 years of age.
_ _
-
_Before you start use it _
Patients should be advised never to use
oral montelukast to treat acute asthma
attacks
and
to
keep
their
usual
appropriate rescue medication for this
purpose readily available. If an acute
attack
occurs,
a
short-acting
inhaled
beta-agonist
should
be
used.
Patients
should
seek
their
doctor's
advice
as
soon
as
possible
if
they
need
more
inhalations of short-acting beta-agonists
than usual.
Montelu

Fachinformation

1.3.1
Montelukast sodium
SPC, Labeling and Package Leaflet
MY
SmPCPIL136740_6
31.07.2019 – Updated: 07.07.2021
Page 1 of 6
NAME OF THE MEDICINAL PRODUCT
Monkasta film-coated tablets 10 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg montelukast (equivalent to 10.4
mg montelukast sodium).
Excipient:
10 mg tablets
lactose
81.94 mg
PHARMACEUTICAL FORM
Film-coated tablet.
The film-coated tablets are apricot-coloured, round, slightly
biconvex, with bevelled edges.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
For the prophylaxis and chronic treatment of asthma in adults and
paediatric patients 12 months of age
and older.
Monkasta is indicated if adults 15 years of age and older for the
relief of daytime and night-time
symptoms of seasonal allergic rhinitis.
POSOLOGY AND METHOD OF ADMINISTRATION
Monkasta should be taken once daily. For the treatment of asthma, the
dose should be taken in the
evening. For seasonal allergic rhinitis, the time of administration
may be individualised to suit patient
needs.
Adults 15 years of Age and Older with Asthma and/or Seasonal Allergic
Rhinitis
The dosage for adults 15 years of age and older is one l0 mg tablet
daily.
_General recommendations_
The therapeutic effect of Monkasta on parameters of asthma control
occurs within one day.
Monkasta may be taken with or without food.
Patients should be advised to continue taking Monkasta even if their
asthma is under control, as well
as during periods of worsening asthma.
Monkasta should not be used concomitantly with other products
containing the same active ingredient,
montelukast.
1.3.1
Montelukast sodium
SPC, Labeling and Package Leaflet
MY
SmPCPIL136740_6
31.07.2019 – Updated: 07.07.2021
Page 2 of 6
No dosage adjustment is necessary for the elderly, or for patients
with renal insufficiency, or mild to
moderate hepatic impairment. There are no data on patients with severe
hepatic impairment. The
dosage is the same for both male and female patients.
_Therapy with Monkasta in relation to other treatment