Singulair Paediatric 4mg chewable tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Montelukast sodium

Available from:

Necessity Supplies Ltd

ATC code:

R03DC03

INN (International Name):

Montelukast sodium

Dosage:

4mg

Pharmaceutical form:

Chewable tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03030200

Patient Information leaflet

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 exercise for patien

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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.
Excipients with known effect: This medicine contains 1.2 mg aspartame
(E
951) per tablet.
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to
say essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
Pink, oval, biconvex-shaped, size 10.9 mm x 7.8 mm with 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
β
-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 4 mg granule 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 necessa