Montelukast Sandoz 5mg Chewable Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MONTELUKAST SODIUM

Boleh didapati daripada:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

MONTELUKAST SODIUM

Unit dalam pakej:

28 Tablets; 30 Tablets; 100 Tablets; 28 Tablets

Dikeluarkan oleh:

LEK S.A.

Risalah maklumat

MONTELUKAST SANDOZ

Montelukast Sodium (4mg Chewable Tablets, 5mg Chewable Tablets, 10mg
Film-Coated Tablets)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET:
1.
What is Montelukast Sandoz used
for
2.
How Montelukast Sandoz works
3.
Before you use Montelukast
Sandoz
4.
How to use Montelukast Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Montelukast Sandoz
8.
Product description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT IS MONTELUKAST
SANDOZ USED FOR
You have been prescribed
Montelukast Sandoz for:
•
Asthma, including preventing
your asthma symptoms during
the day and night.
•
Allergic rhinitis, including
daytime and nighttime
symptoms: nasal congestion,
runny nose, nasal itching, and
sneezing; tearing, itchy, red, and
puffy eyes.
HOW MONTELUKAST SANDOZ
WORKS
Montelukast Sandoz 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 MONTELUKAST
SANDOZ
-
_When you must not use it _
•
If you are allergic (hypersensitive)
to montelukast, or to any of the
ingredients.
-
_Before you start use it _
•
Tell your doctor (or health
care provider) about any
medical problems or
allergies you had.
•
The chewable tablets
contain Aspartame, hence is
unsuitable for patients with
phenylketonuria.
_USE IN CHILDREN _
For children 6 to 14 years old,
Montelukast Sandoz 5 mg chewable
tablets are available.
For children 2 to 5 years old,
Montelukast Sandoz 4 mg chewable
tablets and montelukast 4 mg oral
granules are available.
For children 12 months to 2 years
old with asthma, montelukast 4 mg
oral granules are available.
Safety and effectiveness of
Montelukast Sandoz in children less
th

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Montelukast Sandoz 4 mg Chewable Tablet.
Montelukast Sandoz 5 mg Chewable Tablet.
Montelukast Sandoz 10 mg Film-coated Tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Montelukast Sandoz 4 mg Chewable Tablet
Each chewable tablet contains montelukast sodium equivalent to 4 mg of
montelukast.
Excipient: Aspartame 0.96 mg per tablet.
Montelukast Sandoz 5 mg Chewable Tablet
Each chewable tablet contains montelukast sodium equivalent to 5 mg of
montelukast.
Excipient: Aspartame 1.20 mg per tablet.
Montelukast Sandoz 10 mg film-coated tablet
One film-coated tablet contains montelukast sodium equivalent to
10 mg montelukast.
Excipient:
Lactose 89.10 mg per tablet.
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Montelukast Sandoz 4 mg Chewable Tablet
Chewable tablet.
Oval pink tablet to slightly speckled pink tablet with odour of
cherry, encoded 4 on one side.
Mo
ntelukast Sandoz 5 mg Chewable Tablet
Chewable tablet.
Round pink tablet to slightly speckled pink tablet with odour of
cherry, encoded 5 on one side.
M
ontelukast Sandoz 10 mg film-coated tablet
Film-coated tablet.
A beige, round, biconvex, coated tablet (plain on both sides).
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_RECOMMENDED DOSAGE _
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
dose 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.
_Pediatric Patie