Singulair Paediatric 5 mg chewable tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Montelukast sodium

Dostupné z:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC kód:

R03DC; R03DC03

INN (Medzinárodný Name):

Montelukast sodium

Dávkovanie:

5 milligram(s)

Forma lieku:

Chewable tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Leukotriene receptor antagonists; montelukast

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

1998-02-20

Príbalový leták

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 your 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 prevent the

Súhrn charakteristických

Health Products Regulatory Authority
14 May 2020
CRN009RQ4
Page 1 of 8
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.
Excipients with known effect: This medicine contains 1.5 mg aspartame
(E 951) per tablet.
This medicine contains less than 1 mmol sodium (23mg) per tablet, that
is to say essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
Pink, round, biconvex, diameter 9.5 mm with SINGULAIR engraved on one
side, MSD 275 on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Singulair Paediatric 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 Paediatricmay 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 Paediatric is also indicated in the prophylaxis of asthma in
which the predominant component is exercise-induced
bronchoconstriction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for paediatric 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 Paediatric should be taken
1 hour before or 2 hours after food. No dosage
adjustment within this age group is necessary.
General recommendations
The therapeutic effect of Singulair Paediatric on parameters of asthma
control occurs within one day. Patients should be
advised to continue taki