Singulair Paediatric 4 mg chewable tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Montelukast

MAH:

PCO Manufacturing Ltd.

ATC_code:

R03DC; R03DC03

INN:

Montelukast

dosage:

4 milligram(s)

pharmaceutical_form:

Chewable tablet

prescription_type:

Product subject to prescription which may be renewed (B)

therapeutic_area:

Leukotriene receptor antagonists; montelukast

authorization_status:

Authorised

authorization_date:

2012-08-17

PIL

_ _
_ _
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 f

SPC

Health Products Regulatory Authority
27 July 2020
CRN009VLG
Page 1 of 2
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.
Excipient with known effect: This medicine contains aspartame (E 951).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable Tablet.
_Product imported from The UK and Poland:_
Pink, oval, bi-convex-shaped, SINGULAIR engraved on one side, MSD 711
on the other.
4 CLINICAL PARTICULARS
As per PA1286/046/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/046/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Mannitol (E421)
Microcrystalline cellulose
Hyprolose (E463)
Red ferric oxide (E172)
Croscarmellose sodium
Cherry flavour
Aspartame (E951)
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from light and
moisture.
Health Products Regulatory Authority
27 July 2020
CRN009VLG
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters in packages of 28 tablets contained in an overlabelled outer
cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/111/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17
th
August 2012
10 DATE OF REVISION OF THE TEXT
July 2020