M-KAST 10 (Montelukast Tablets 10mg)

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

MONTELUKAST SODIUM

Dostupné z:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Medzinárodný Name):

MONTELUKAST SODIUM

Počet v balení:

30tablet Tablets

Výrobca:

Aurobindo Pharma Limited, Unit-VII (SEZ)

Príbalový leták

_Consumer Medication Information Leaflet (RiMUP) _
M-KAST 10 (MONTELUKAST TABLETS 10MG)
Montelukast Sodium Tablets (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What M-KAST 10 is used for
2.
How M-KAST 10 works
3.
Before you use M-KAST 10
4.
How to use M-KAST 10
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of M-
KAST 10
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS M-KAST 10 USED FOR
Montelukast sodium is the active
ingredient in M-KAST 10. It is used
as a prevention and also as a
treatment for chronic asthma in
adults and adolescents from 15 years
old onwards.
It is also used for the relief of
daytime and night-time symptoms of
seasonal allergic rhinitis in adults and
adolescents from 15 years old
onwards.
HOW M-KAST 10 WORKS
Montelukast 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 M-KAST 10
-When you must not use it
You must not use this product if you
are hypersensitive to active
ingredient or excipients of this
product.
-Before you start to use it
Tell your doctor about any medical
problems or allergies you have now
or have had. If your asthma or
breathing gets worse, tell your doctor
immediately.
This product is not meant to treat
acute asthma attacks. Please follow
doctor’s instructions in case you have
an acute asthma attack.
Do not take this medication if your
doctor has not prescribed it to you.
This medication is not meant to
substitute current medications that
your doctor has prescribed to you.
Please consult your doctor if you
experience symptoms such as a flu-
like illness, numbness of arms or
legs, worsening of your asthma
condition or a rash while on this

Súhrn charakteristických

NAME OF DRUG PRODUCT :
Montelukast Tablets 10 mg.
(TRADE) NAME OF PRODUCT:
M - KAST 10
STRENGTH:
10 mg.
PHARMACEUTICAL DOSAGE FORM:
Film coated Tablet.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
_Montelukast Tablets 10 mg:_
Each
film
coated
tablet
contains
Montelukast
Sodium
Ph.Eur.
equivalent to Montelukast 10 mg.
PHARMACEUTICAL FORM:
_Montelukast Tablets 10 mg: _ Beige, rounded square shaped, film
coated tablets debossed with 'X' on one side and '54' on other side.
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS
For the prophylaxis and chronic treatment of asthma in adults and
patients 15 years of age and older.
For the relief of daytime and nighttime symptoms of seasonal allergic
rhinitis in adults and patients 15 years of age and older.
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.
_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 10-mg tablet
daily.
_General recommendations_
The therapeutic effect of montelukast on parameters of asthma control
occurs within one day. Montelukast tablets and chewable tablets can
be taken with or without food. Patients should be advised to continue
taking Montelukast while their asthma is controlled, as well as during
periods of worsening asthma.
No dosage adjustment is necessary for pediatric patients, for the
elderly, for patients with renal insufficiency, or mild-to-moderate
hepatic impairment, or for patients of either gender.
Montelukast is a long term-controller medication which should not be
substituted for short acting beta-agonists. It is effective alone or
in
combination with other prophylactic agent. Montelukast is a preventive
agent, which should be used in addition to other drugs for the
management of asth