TELKAST 4 (Montelukast Chewable Tablets 4mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MONTELUKAST SODIUM

Boleh didapati daripada:

MYLAN HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

MONTELUKAST SODIUM

Unit dalam pakej:

10tablet Tablets; 3 X 10tablet Tablets

Dikeluarkan oleh:

MSN Laboratories Private Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
TELKAST 4 & 5
Montelukast Chewable Tablets 4mg/5mg
pg. 1
WHAT IS IN THIS LEAFLET
1.
What
_Telkast 4&5 _
is used for
2.
How
_Telkast 4&5 _
works
_3._
_ _
Before you use
_Telkast 4&5 _
_4._
_ _
How to use
_Telkast 4&5 _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Telkast 4&5 _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT _TELKAST 4&5 _IS USED FOR
_Telkast 4&5 _
can be used for the
prophylaxis and chronic treatment of
asthma in adults and pediatric patients 12
months of age and older.
_Telkast 4&5 _
is indicated if adults 15
years of age and older for the relief of
daytime and night-time symptoms of
seasonal allergic rhinitis.
HOW _TELKAST 4&5 _WORKS
_Telkast _
_4&5 _
contain
active
substance
called Montelukast Sodium. Montelukast
is a leukotriene receptor antagonist.
BEFORE YOU USE _TELKAST 4&5 _
-
_When you must not use it _
Montelukast Sodium tablets must not be
used for the patient with hypersensitivity
to the active substance or to any of the
excipients.
-
_Before your start to use it _
Check
with
your doctor or pharmacist
before taking your medicine if
•
Patient should be advised never to use
oral montelukast to treat acute asthma
attacks.
•
Should not be abruptly substituted for
inhaled or oral corticosteroids.
•
Physicians
should
be
alert
to
eosinophilia,
vasculitic
rash,
worsening
pulmonary
symptoms,
cardiac
complications,
and/or
neuropathy presenting in their patients
•
Unsuitable
for
phenylketonurics
Montelukast contains aspartame
-
_Taking other medicines _
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines. This includes medicines
you buy without a prescription, including
herbal medicines.
In particular, tell your doctor if you are
taking any of the following medicines.
This is because it can increase the chance
of you getting side effects, when taken
with
_Telkast 4&5_
:
•
Phenobarbital - used t

Ciri produk

Body System Class
Adult Patients 15 years
and older
Paediatric Patients 6 to
14 years old
Nervous system disorders
Headache
Headache
Gastro-intestinal disorders
Abdominal pain
TELKAST 4 (Montelukast Chewable Tablets 4mg)
TELKAST 5 (Montelukast Chewable Tablets 5mg)
Label Claim:
Telkast 4 (Montelukast Chewable Tablets 4 mg)
Each uncoated chewable tablet contains Montelukast Sodium Ph.Eur
equivalent to Montelukast 4 mg.
Telkast 5 (Montelukast Chewable Tablets 5 mg)
Each uncoated chewable tablet contains Montelukast Sodium Ph. Eur
equivalent to Montelukast
5 mg.
List of excipients:
Telkast 4
Lactose Anhydrous DC, Mannitol (DC grade), Hydroxy Propyl Cellulose,
Sodium Starch Glycolate,
Aspartame, Pineapple flavour, Colloidal Silicon Dioxide, Magnesium
Stearate.
Telkast 5
Lactose Anhydrous DC, Mannitol (DC grade), Hydroxy Propyl Cellulose,
Sodium Starch Glycolate,
Aspartame, Pineapple flavour, Colloidal Silicon Dioxide, Magnesium
Stearate.
Product descriptions
Telkast 4
White to off-white, pineapple flavoured, sweet round shaped biconvex
chewable tablets.
Telkast 5
White to off-white, pineapple flavoured, sweet round shaped biconvex
chewable tablets.
Therapeutic indications
For the prophylaxis and chronic treatment of asthma in adults and
pediatric patients 12 months
of age and older.
Telkast 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_
Telkast 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 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 5-mg chewable
tablet daily.
Pediatric Patients 2 to 5 Years of Age with Asthma and/or Seasonal
Allergic Rhinitis: