SINGULAIR PAEDIATRIC 4 Milligram Tablets Chewable

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

MONTELUKAST SODIUM

Inapatikana kutoka:

Primecrown 2010 Ltd

ATC kanuni:

R03DC03

INN (Jina la Kimataifa):

MONTELUKAST SODIUM

Kipimo:

4 Milligram

Dawa fomu:

Tablets Chewable

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Leukotriene receptor antagonists

Idhini hali ya:

Authorised

Idhini ya tarehe:

2012-08-31

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER 
SINGULAIR® PAEDIATRIC 4 MG 
CHEWABLE TABLETS 
montelukast 

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 docto

Tabia za bidhaa

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: _Aspartame (E951) 1.2 mg per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable Tablet.
_Product imported from Lithuania and Poland:_
Pink, oval, bi-convex-shaped, SINGULAIR engraved on one side, MSD 711 on the other.
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
-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 shou