Singulair 5mg 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 5 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

MONTELUKAST 5 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Withdrawn

Authorization date:

2005-06-30

Patient Information leaflet

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

SINGULAIR 5 MG CHEWABLE TABLETS 
montelukast 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR
YOUR CHILD START TAKING THIS MEDICINE. 


Keep this leaflet. You may need to read it again. 


If you have any further questions,
please ask your doctor or pharmacist. 


This medicine has been prescribed for you or your child. Do
not pass it on to others. It may 
harm them, even if their symptoms are the same as
your or your child’s. 


If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET: 
1. 
What SINGULAIR is and what it is used for 
2. 
Before you take SINGULAIR 
3. 
How to take SINGULAIR 
4. 
Possible side effects 
5. 
How to store SINGULAIR 
6. 
Further information 

1. 
WHAT SINGULAIR IS AND WHAT IT IS USED FOR 

SINGULAIR is a leukotriene receptor antagonist that blocks
substances called 
leukotrienes.Leukotrienes cause narrowing and swelling of airways
in the lungs. By blocking 
leukotrienes, SINGULAIR improves asthma symptoms and
helps control asthma. 
_ _
Your doctor has prescribed SINGULAIR to treat asthma,
preventing your asthma symptoms during 
the day and night. 



SINGULAIR is used for the treatment of patients who are
not adequately controlled on their 
medication and need additional therapy. 


SINGULAIR may also be used as an alternative treatment to inhaled
corticosteroids for 6 to 
14 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 also helps prevent the narrowing of airways triggered
by exercise. 

Your doctor will determine how SINGULAIR should be
used depending on the symptoms and 
severity o

Summary of Product characteristics

1 

SUMMARY OF PRODUCT CHARACTERISTICS 

2 

1. 
NAME OF THE MEDICINAL PRODUCT 

SINGULAIR

5 MG CHEWABLE TABLETS 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

ONE CHEWABLE TABLET CONTAINS MONTELUKAST SODIUM, WHICH IS
EQUIVALENT 
TO 5 MG MONTELUKAST. 
_EXCIPIENT_: ASPARTAME (E 951) 1.5 MG PER TABLET. 
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1. 

3. 
PHARMACEUTICAL FORM 

CHEWABLE TABLET. 

Pink, round, biconvex, diameter 9.5 mm with SINGULAIR engraved on
one side and MSD 275 on the 
other. 

4. 
CLINICAL PARTICULARS 

_4.1 _
_THERAPEUTIC INDICATIONS _

SINGULAIR is indicated in the treatment of asthma as add-on
therapy in those 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 
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 in which
the predominant component is 
exercise-induced bronchoconstriction. 

_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _

The dosage for paediatric patients 6-14 years of age is
one 5 mg chewable tablet daily to be taken in 
the evening. The tablets are to be chewed before
swallowing. 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. 

_General recommendations. _The therapeutic effect of SINGULAIR on
parameters of asthma control 
o