Singulair Paediatric 5 mg Chewable Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Montelukast

Available from:

IMED Healthcare Ltd.

ATC code:

R03DC; R03DC03

INN (International Name):

Montelukast

Dosage:

5 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:

2012-05-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR
® PAEDIATRIC 5 MG CHEWABLE TABLETS
montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR
YOUR CHILD.
•
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 you or 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 or your child's.
•
If you or your child get 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 you take 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 asthma,
preventing
your asthma symptoms during the day and night.
•
Singulair Paediatric is used for the treatment of paediatric patients
6 to 14
years of age 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 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 Paediatric also helps prevent the narro

Summary of Product characteristics

Health Products Regulatory Authority
17 July 2023
CRN00DPPN
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Singulair Paediatric 5 mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains montelukast sodium, which is equivalent
to 5 mg montelukast.
Excipients with known effect:
This medicinal product contains 1.5 mg aspartame (E 951) per tablet
This medicinal product contains benzyl alcohol (E 1519).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
_Product imported from Poland:_
Pink, round, biconvex, diameter 9.5 mm with SINGULAIR engraved on one
side, MSD 275 on the other.
4 CLINICAL PARTICULARS
As per PA23198/014/003
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/014/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Mannitol (E 421)
Microcrystalline cellulose
Hyprolose (E 463)
Red ferric oxide (E 172)
Croscarmellose sodium
Cherry flavor (containing benzyl alcohol (E 1519))
Aspartame (E 951)
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
blister strips and outer carton of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C.
Store in the original package in order to protect from light and
moisture.
Health Products Regulatory Authority
17 July 2023
CRN00DPPN
Page 2 of 2
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
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
PPA1463/064/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 11
th
May 2012
10 DATE OF REVISION OF THE TEXT
July 2023