SINGULAIR PAEDIATRIC 5 Milligram Tablets Chewable

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

MONTELUKAST SODIUM

Dostupné s:

Primecrown 2010 Ltd

ATC kód:

R03DC03

INN (Mezinárodní Name):

MONTELUKAST SODIUM

Dávkování:

5 Milligram

Léková forma:

Tablets Chewable

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Leukotriene receptor antagonists

Stav Autorizace:

Authorised

Datum autorizace:

2012-08-31

Informace pro uživatele

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. 

• 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 you or your child. 
Do not pass it on to others. It may harm them, even if 
their symptoms are the same as your or 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 you take SINGULAIR Paediatric 
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 asthma, 
preventing your asthma symptoms during the day and night. 

• SINGULAIR Paediatric is used for the treatment of 
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 6 to14 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. 
Your doctor will determine how SINGULAIR Paediatric 
shoul

Charakteristika produktu

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_: Aspartame (E 951) 1.5 mg per tablet.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Chewable Tablet.
_Product imported from Lithuania and Poland:_
Pink, round, biconvex with SINGULAIR engraved on one side, MSD 275 on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 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 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 in which the predominant component is exercise-induced
bronchoconstriction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage for pediatric patients 6-14 years of age is one 5-mg chewable tablet daily to be taken in the evening. If
taken in connection with food, SINGULAIR should be taken 1 hour before or two hours after food. No dosage
adjustment within this age group is necessary.
_General recommendations. _The therapeutic effect of SINGULAIR on parameters of asthma control occurs within one
day. Patients should be advised to continue taking SINGULAIR even if