Singulair 4mg chewable Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MONTELUKAST

Available from:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

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Withdrawn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:

2005-06-30

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR PAEDIATRIC 4 MG CHEWABLE TABLETS
montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICINE TO
YOUR CHILD BECAUSE IT CONTAINS
IMPORTANT INFORMATION.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for your child only. Do not pass it
on to others. It may
harm them, even if their signs of illness are the same as your
child’s.

If your child gets any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Singulair Paediatric is and what it is used for
2.
What you need to know before your child takes Singulair Paediatric
3.
How to take Singulair Paediatric
4.
Possible side effects
5.
How to store Singulair Paediatric
6.
Contents of the pack and other information
1.
WHAT SINGULAIR PAEDIATRIC IS AND WHAT IT IS USED FOR
WHAT SINGULAIR PAEDIATRIC IS
Singulair Paediatric is a leukotriene receptor antagonist that blocks
substances called leukotrienes.
HOW SINGULAIR PAEDIATRIC WORKS
Leukotrienes cause narrowing and swelling of airways in the lungs. By
blocking leukotrienes,
Singulair Paediatric improves asthma symptoms and helps control
asthma._ _
WHEN SINGULAIR PAEDIATRIC SHOULD BE USED
Your doctor has prescribed Singulair Paediatric to treat your
child’s asthma, preventing asthma
symptoms during the day and night.

Singulair Paediatric is used for the treatment of 2 to 5 year old
patients who are not
adequately controlled on their medication and need additional therapy.

Singulair Paediatric 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.

Singulair Paediatric also helps prevent the narrowing of airways
triggered by exercis

Summary of Product characteristics

Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT
SINGULAIR PAEDIATRIC 4 MG CHEWABLE TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
ONE CHEWABLE TABLET CONTAINS MONTELUKAST SODIUM, WHICH IS
EQUIVALENT TO 4 MG MONTELUKAST.
_ _
EXCIPIENT WITH KNOWN EFFECT: THIS MEDICINE CONTAINS 1.2 MG
ASPARTAME (E 951) PER TABLET.
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1.
3.
PHARMACEUTICAL FORM
CHEWABLE TABLET.
Pink, oval, bi-convex-shaped, SINGULAIR engraved on one side and MSD
711 on the other.
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Singulair is indicated in the treatment of asthma as add-on therapy in
those 2 to 5year old patients
with mild to moderate persistent asthma who are inadequately
controlled on inhaled corticosteroids
and in whom “as-needed” short acting

-agonists provide inadequate clinical control of asthma.
Singulair 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).
Singulair 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 is to be given to a child under adult
supervision. For children who have
problems consuming a chewable tablet, a granule formulation is
available (see Singulair Paediatric
4 mg Granules SmPC). The recommended dose for paediatric patients 2-5
years of age is one 4 mg
chewable tablet daily to be taken in the evening. If taken in
connection with food, Singulair should
be taken 1 hour before or 2 hours after food. No dosage adjustment
within this age group is
necessary.
_ _
Page 2 of 12
General recommendations_ _
The therapeutic effect of Singulair on parameters of asthma control
occurs within on