Montelukast Mylan 4mg Chewable Tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MONTELUKAST

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

R03DC03

INN (International Name):

MONTELUKAST 4 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

MONTELUKAST 4 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Withdrawn

Authorization date:

2012-02-01

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MONTELUKAST MYLAN 4 MG
montelukast
FOR CHILDREN 2 TO 5 YEARS OLD
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor, pharmacist or
nurse.
_ _
−
This medicine has been prescribed for you or your child only. Do not
pass it on to others. It may
harm them, even if their signs of illness are the same as yours or
your child’s.
−
If you or your child get any side effects, talk to your doctor,
pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Montelukast Mylan 4 mg is and what it is used for
2.
What you need to know before you give Montelukast Mylan 4 mg
3.
How to give Montelukast Mylan 4 mg
4.
Possible side effects
5.
How to store Montelukast Mylan 4 mg
6.
Contents of the pack and other information
1.
WHAT MONTELUKAST MYLAN 4 MG IS AND WHAT IT IS USED FOR
Montelukast Mylan 4 mg contains montelukast, which is a leukotriene
receptor antagonist that
blocks substances called leukotrienes. Leukotrienes cause narrowing
and swelling of airways in
your lungs. By blocking leukotrienes, Montelukast Mylan 4 mg improves
asthma symptoms and
helps control asthma.
Your doctor has prescribed Montelukast Mylan 4 mg to treat your
child’s asthma, preventing
asthma symptoms during the day and night.
•
Montelukast Mylan 4 mg is used for the treatment of 2 to 5 year old
patients who are not
adequately controlled on their medication and need additional therapy.
•
Montelukast Mylan 4 mg may also be used as an alternative treatment to
inhaled corticosteroids
for 2 to 5 year old patients who have not recently taken oral
corticosteroids for their asthma and
have shown that they are unable to use inhaled corticosteroids.
•
Montelukast Mylan 4 mg also helps prevent the narrowing of airways
triggered by exercise for

Summary of Product characteristics

PAGE 1 OF 12
1.
NAME OF THE MEDICINAL PRODUCT
Montelukast Mylan 4 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains montelukast sodium, which is equivalent
to 4 mg montelukast.
Excipient with known effect: Each chewable tablet contains 2 mg
aspartame (E951).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable Tablet
A white to off-white, oval, biconvex tablet (9.5mm x 4.9mm) debossed
with “M” on one side and
“MS1” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Montelukast Mylan 4 mg is indicated in the treatment of asthma as
add-on therapy in those 2 to 5
year old
patients with mild to moderate persistent asthma who are inadequately
controlled on
inhaled corticosteroids and in whom “as-needed” short acting
beta-agonists provide inadequate
clinical control of asthma.
Montelukast Mylan 4 mg may also be an alternative treatment option to
low-dose inhaled
corticosteroids for 2 to 5 year old patients with mild persistent
asthma who do not have a recent
history of serious asthma attacks that required oral corticosteroid
use, and who have demonstrated
that they are not capable of using inhaled corticosteroids (see
section 4.2).
Montelukast Mylan 4 mg is also indicated in the prophylaxis of asthma
from 2
_ _
years of age and
older
_ _
in which the predominant component is exercise-induced
bronchoconstriction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This medicinal product should be given to a child under adult
supervision.
The dosage for paediatric patients 2-5 years of age is one 4mg
chewable tablet daily to be taken in
the evening.
No dosage adjustment within this age group is necessary.
The Montelukast Mylan 4 mg chewable tablet formulation is not
recommended below 2 years of
age. The tablets are to be chewed before swallowing. For children who
have problems consuming a
chewable tablet, other pharmaceutical forms such as a granule
formulation may be available.
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_ _
_General recommendations. _
The therapeut