Singulair Paediatric 5 mg chewable tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Montelukast sodium

Available from:

PCO Manufacturing Ltd.

ATC code:

R03DC; R03DC03

INN (International Name):

Montelukast sodium

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:

2007-01-19

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 yours 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 preve

Summary of Product characteristics

Health Products Regulatory Authority
23 August 2023
CRN00DRK8
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.
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 Italy and Poland:_
A pink, round, biconvex chewable tablet with ‘Singulair’ engraved
on one side and ‘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
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
Do not store above 30 °C.
Store in the original package in order to protect from light and
moisture.
Health Products Regulatory Authority
23 August 2023
CRN00DRK8
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters in packages of 28 tablets contained in an 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
PPA0465/111/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19 January 2007
Date of last renewal: 19 January 2012
10 DATE OF REVISION OF THE TEXT
August 2023