M-KAST 5 (Montelukast chewable Tablets 5mg )

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

MONTELUKAST SODIUM

Mevcut itibaren:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International Adı):

MONTELUKAST SODIUM

Paketteki üniteler:

30tablet Tablets

Tarafından üretildi:

Aurobindo Pharma Limited, Unit-VII (SEZ)

Bilgilendirme broşürü

_Consumer Medication Information Leaflet (RiMUP) _
M-KAST 4 (MONTELUKAST CHEWABLE TABLETS 4MG)
M-KAST 5 (MONTELUKAST CHEWABLE TABLETS 5MG)
Montelukast sodium as Montelukast 4mg, Montelukast sodium as
Montelukast 5mg
1
WHAT IS IN THIS LEAFLET
1.
What M-KAST is used for
2.
How M-KAST works
3.
Before you use M-KAST
4.
How to use M-KAST
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of M-
KAST
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS PRODUCT M-KAST FOR
M-KAST is used to prevent and treat
chronic asthma in adults and in
children from 12 months of age and
older.
It is also indicated in adults and
children from 2 years of age onwards
in the relief of daytime and night-
time symptoms of seasonal allergic
rhinitis.
HOW M-KAST WORKS
Montelukast is the active ingredient
in M-KAST. It binds to special
receptors found in your airways,
preventing the symptoms of asthma
and seasonal allergic rhinitis.
BEFORE YOU USE M-KAST
-When you must not use it
Do not use M-KAST if you are
allergic to its active ingredient or any
of the inactive ingredients listed.
-Before you start to use it
Do not use M-KAST to treat an acute
asthmatic attack. Please use an
appropriate medication as
recommended by your doctor or
pharmacist (usually an inhaler type
medicine) to treat your asthmatic
attack.
M-KAST contains an ingredient
called aspartame. Do not use this
product if you suffer from a
condition called phenylketonuria.
Please get your doctor or
pharmacist’s advice if you are
unsure.
Effects on ability to drive and use
machines: montelukast has no or
negligible influence on the ability to
drive and use machines. However,
drowsiness or dizziness may occur.
-Taking other medications
Please seek your doctor or
pharmacist’s advice if you are on
these current medications as they
have a potential to interact with M-
KAST.
•
Medicines used in treatment
of epilepsy such as
phenytoin and phenobarbital
•
Antibiotics such as
rifampicin
HOW TO USE M-KAST

Ürün özellikleri

Black
A/s: 165 x 240 mm
NAME OF DRUG PRODUCT:
Montelukast Chewable Tablets 4 mg
Montelukast Chewable Tablets 5 mg
(TRADE) NAME OF PRODUCT:
M-KAST 4
M-KAST 5
STRENGTHS:
4 mg & 5 mg
PHARMACEUTICAL DOSAGE FORM:
Chewable Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION:
M-KAST
4:
Each
chewable
tablet
contains
Montelukast
Sodium
Ph.Eur.
equivalent to Montelukast 4 mg.
M-KAST
5:
Each
chewable
tablet
contains
Montelukast
Sodium
Ph.Eur.
equivalent to Montelukast 5 mg.
PHARMACEUTICAL FORM:
M-KAST 4: Pink coloured, mottled, oval, biconvex, uncoated tablets,
debossed
with ‘X’ on one side and ‘52’ on the other side.
M-KAST 5: Pink coloured, mottled, round, biconvex, uncoated tablets,
debossed
with ‘X’ on one side and ‘53’ on other side.
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS:
Montelukast is indicated for the prophylaxis and chronic treatment of
asthma in
adults and pediatric patients 12 months of age and older.
Montelukast is indicated in adults and pediatric patients 2 years of
age and older
for the relief of daytime and nighttime symptoms of seasonal allergic
rhinitis.
POSOLOGY AND METHOD OF ADMINISTRATION:
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
individualized
to suit patient needs.
Patients with both asthma and allergic rhinitis should take only one
tablet daily
in the evening.
_Pediatric Patients 2 to 5 Years of Age with Asthma and/or Seasonal
Allergic _
_Rhinitis_
The dosage for pediatric patients 2 to 5 years of age is one 4mg
chewable tablet
daily.
_Pediatric Patients 6 to 14 years of Age with Asthma and/or Seasonal
Allergic _
_Rhinitis_
The dosage for pediatric patients 6 to 14 years of age is one 5mg
chewable
tablet daily.
_General Recommendations_
The therapeutic effect of Montelukast on parameters of asthma control
occurs
within one day. Montelukast chewable tablets can be taken with or
without food.
Patients should be advised to continue taking Montelukast while their
asthma is
cont