ALTRA TABLET 10MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MONTELUKAST SODIUM

Boleh didapati daripada:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

MONTELUKAST SODIUM

Unit dalam pakej:

3 x 10tablet Tablets

Dikeluarkan oleh:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Risalah maklumat

ALTRA TABLET 10MG
®
Montelukast 10mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Altra Tablet _
is used for
2.
How
_Altra Tablet _
works
3.
Before you use
_Altra Tablet _
4.
How to use
_Altra Tablet _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Altra Tablet _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _Altra Tablet _
IS USED FOR
Montelukast helps to treat asthma, prevent
and control asthma symptoms. It is used to
improve
seasonal
allergy
(hay
fever)
symptoms.
It is not used for the management of acute
asthma attacks.
_ _
HOW _Altra Tablet _ WORKS
Montelukast
is
a
leukotriene
receptors
antagonist,
which
suppresses
leukotriene
from narrowing the airways.
BEFORE YOU USE _Altra Tablet _
-
_When you must not use it _
Do
not
take
this
medicine
if
you
are
allergic
(hypersensitivity)
to
the
montelukast or any other ingredients in this
medicine.
_ _
-
_Before you start use it _
Tell your doctor or pharmacist if you:

have acute asthma attacks.

have
inhaled
or
orally
taken
corticosteroids.

are sensitive to aspirin.
_ _

have problem with simple sugar intake
(galactose
intolerance,
Lapp
lactase
deficiency,
glucose-galactose
malabsoprtion).
_ _

are pregnant or breast-feeding.
_ _
-
_Taking other medicines _
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines,
such
as
phenytoin
and
phenobarbital
(for
epilepsy
treatment),
rifampicin (for tuberculosis and some other
infections) and medicines obtained without
prescription.
HOW TO USE _Altra Tablet _
-
_How much to use _
Patients with asthma and/or hay fever:

Adults 15 years old and above – 10mg
(1 tablet) daily.
Your doctor or pharmacist will prescribe
based on individual conditions.
-
_When to use it _
Once-daily doses should be taken in the
evening
-
_How long to use it _
Follow the prescription from your doctor
or pharmacist.
Ask
your doctor or pharmacist before
prolong use of this medi

Ciri produk

-
IMPORTANT INFORMATION. PLEASE READ CAREFULLY.
FIIM-COATED TABLET 10MG
CHEWABLE TABLET 4MG & 5MG
COMPOSITION
Altra Tablet 10mg: Each film-coated tablet contains 10mg Montelukast
(as Montelukast Sodium).
Altra Chewable Tablet 5mg: Each chewable tablet contains 5mg
Montelukast (as Monlelukast Sodium).
Altra Chewable Tablet 4mg: Each chewable tablet contains 4mg
Montelukast (as Montelukast Sodium).
PHARMACODYNAMICS
Montelukast is a selective and competitive antagonist of the
leukotriene
C
,.
, o
,.
, and E
,.
receptors, stimulation of which by circulating leukotrienes
is thought to play a role in the pathogenesis of asthma.
The drug suppresses both early and late bronchoconstrictor responses
to inhaled antigens and irritants, but Is not suitable for the
management
of acute attacks of asthma.
PHARMACOKINETICS
Peak plasma concentrations of montelukast are achieved in 3 to 4 hours
after oral doses. The mean oral bioavailability is 64%.
Montelukast is more than 99% bound to plasma proteins. It is
extensively
metabolised in the
liver by cytochrome P450 isoenzymes CYP3A4,
CYP2A6, and CYP2C9, and is excreted principally in the faeces via the
bile.
- INDICATIONS
Altra Tablet 10mg:
• Chronic and prophylaxis treatment of asthma in adults
• Symptomatic relief of seasonal allergic rhinitis in adults
Altra Chewable Tablet 4mg & 5mg:
• Chronic and prophylaxis treatment of asthma in adults and children
2
years old and above.
• Symptomatic relief of seasonal allergic rhinitis in adults and
children 2
years old and above.
DOSAGE AND ADMINISTRATION
To be administered orally. Once daily in the evening.
_Patients with asthma and/or seasonal allergic rhinitis _
• Adults 15 years old and above - one film-coated tablet (10mg)
daily.
• Children 6 to 14 years old - one chewable tablet (5mg) daily.
• Children 2 to 5 years old - one chewable tablet (4mg) daily.
No dosage adjustment is necessary for pediatric patients, for the
elderly,
for
patients
with
renal
insufficiency,
or
mild-to-moderate
hepatic
impairment, or f
o
r patien