Singulair Paediatric 5 mg chewable tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Montelukast sodium

Dostupné s:

Imbat Limited

ATC kód:

R03DC; R03DC03

INN (Mezinárodní Name):

Montelukast sodium

Dávkování:

5 milligram(s)

Léková forma:

Chewable tablet

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Leukotriene receptor antagonists; montelukast

Stav Autorizace:

Authorised

Datum autorizace:

2013-07-26

Informace pro uživatele

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR
® PAEDIATRIC 5MG CHEWABLE TABLETS
(montelukast)
Your medicine is available using the name SINGULAIR Paediatric
5mg chewable tablets but will be referred to as SINGULAIR
Paediatric throughout this leaflet.
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 yours 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 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 narrowing of
airways triggered by exercise.
Your doctor will determine how SINGULAIR Paediatric should be

Charakteristika produktu

Health Products Regulatory Authority
11 November 2019
CRN009FZ0
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Singulair Paediatric 5 mg chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains montelukast sodium equivalent to 5mg
montelukast.
Also contains aspartame (E951).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
_Product sourced from Poland:_
Pink, round, biconvex tablets marked with ‘SINGULAIR’ on one side
and ‘MSD 275’ on the other side.
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 β-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 their
asthma is under control, as well as during periods of
worsening asthma.
No dosage adjustment is necessary for patients with renal
insufficiency, or mild to moderate hepatic imp