Singulair Paediatric 4 mg Chewable Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Montelukast

Beschikbaar vanaf:

IMED Healthcare Ltd.

ATC-code:

R03DC; R03DC03

INN (Algemene Internationale Benaming):

Montelukast

Dosering:

4 milligram(s)

farmaceutische vorm:

Chewable tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Leukotriene receptor antagonists; montelukast

Autorisatie-status:

Authorised

Autorisatie datum:

2012-05-11

Bijsluiter

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 patient

Productkenmerken

Health Products Regulatory Authority
13 November 2018
CRN008N4V
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: _Aspartame (E 951)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
_Product imported from 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
Microcrystalline cellulose
Hyprolose (E 463)
Red ferric oxide (E 172)
Croscarmellose sodium
Cherry flavour
Aspartame (E 951)
Magnesium stearate
6.2 INCOMPATIBILITIES
Health Products Regulatory Authority
13 November 2018
CRN008N4V
Page 2 of 2
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister strips and
outer carton 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.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium blister strips in an over-labelled cardboard carton
containing 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE
MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF
THE
PRODUCT
Any unused product or waste material should be disposed of in
accordance with
local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/064/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 11
th
May 2012
10 DATE OF REVISION OF THE TEXT
February 2017