Singulair Paediatric 4mg chewable tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Montelukast sodium

थमां उपलब्ध:

Imbat Limited

ए.टी.सी कोड:

R03DC; R03DC03

INN (इंटरनेशनल नाम):

Montelukast sodium

डोज़:

4 milligram(s)

फार्मास्यूटिकल फॉर्म:

Chewable tablet

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Leukotriene receptor antagonists; montelukast

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2013-07-26

सूचना पत्रक

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR
® PAEDIATRIC 4MG CHEWABLE TABLETS
(montelukast)
Your medicine is available using the name SINGULAIR Paediatric
4mg chewable tablets but will be referred to as Singulair
Paediatric throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR
CHILD STARTS 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 your child. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as 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 Paediatric is and what it is used for
2.
Before SINGULAIR Paediatric is taken
3.
How to take SINGULAIR Paediatric
4.
Possible side effects
5.
How to store SINGULAIR Paediatric
6.
Further information
1.
WHAT SINGULAIR PAEDIATRIC IS AND WHAT IT
IS USED FOR
SINGULAIR Paediatric is a leukotriene receptor antagonist that
blocks substances called leukotrienes. Leukotrienes cause
narrowing and swelling of airways in the lungs. By blocking
leukotrienes, SINGULAIR Paediatric improves asthma symptoms
and helps control asthma.
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 patients 2 years of age and
older.
Your doctor will dete

उत्पाद विशेषताएं

Health Products Regulatory Authority
11 November 2019
CRN009FZ0
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Singulair Paediatric 4mg chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains montelukast sodium equivalent to 4mg
montelukast.
Also containsaspartame (E951).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
_Product sourced from Poland:_
Pink, oval, bi-convex-shaped tablets marked with ‘SINGULAIR’ on
one side and ‘MSD 711’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SINGULAIR 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
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
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 SPC). The dosage 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 two hours after food. No dosage
adjustment within this age group is necessary. The
SINGULAIR 4mg chewable tablet is not recommended below 2 years of age.
_General recommenda