Singulair Paediatric 4 mg granules

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Montelukast sodium

Հասանելի է:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC կոդը:

R03DC; R03DC03

INN (Միջազգային անվանումը):

Montelukast sodium

Դոզան:

4 milligram(s)

Դեղագործական ձեւ:

Granules

Ռեկվիզորի տեսակը:

Product subject to prescription which may be renewed (B)

Թերապեւտիկ տարածք:

Leukotriene receptor antagonists; montelukast

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

2003-03-07

Տեղեկատվական թերթիկ

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR
® PAEDIATRIC 4 MG GRANULES
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 6 months 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 patie

Ապրանքի հատկությունները

Health Products Regulatory Authority
14 May 2020
CRN009RQ4
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Singulair Paediatric 4 mg granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet of granules contains montelukast sodium, which is
equivalent to 4 mg montelukast.
Excipient with known effect: This medicine contains less than 1 mmol
sodium (23 mg) per sachet, that is to say essentially
'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules.
White, granular, coarse, free-flowing homogeneous solid with no
extraneous particles present.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Singulair Paediatric is indicated in the treatment of asthma as add-on
therapy in those 6 months 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 β‑agonists provide inadequate clinical control of
asthma.
Singulair Paediatric 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 Paediatric 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
Posology
This medicinal product is to be given to a child under adult
supervision. The recommended dose for paediatric patients
6 months to 5 years of age is one sachet of 4 mg granules daily to be
taken in the evening. No dosage adjustment within this
age group is necessary. Efficacy data from clinical trials in
paediatric patients 6 months to 2years of age with persistent asthma
are limited. Patients should be evaluated after 2 to 4weeks for
response to montelukast tr