Singulair Paediatric 4 mg chewable tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Montelukast

Доступна з:

Merck Sharp & Dohme Ireland (Human Health) Limited

Код атс:

R03DC; R03DC03

ІПН (Міжнародна Ім'я):

Montelukast

Дозування:

4 milligram(s)

Фармацевтична форма:

Chewable tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Leukotriene receptor antagonists; montelukast

Статус Авторизація:

Not marketed

Дата Авторизація:

1998-02-20

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR® 4 MG CHEWABLE TABLETS
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 is and what it is used for
2.
What you need to know before your child takes Singulair
3.
How to take Singulair
4.
Possible side effects
5.
How to store Singulair
6.
Contents of the pack and other information
1.
WHAT SINGULAIR IS AND WHAT IT IS USED FOR
WHAT SINGULAIR IS
Singulair is a leukotriene receptor antagonist that blocks substances
called leukotrienes.
HOW SINGULAIR WORKS
Leukotrienes cause narrowing and swelling of airways in the lungs. By
blocking leukotrienes,
Singulair improves asthma symptoms and helps control asthma.
_ _
WHEN SINGULAIR SHOULD BE USED
Your doctor has prescribed Singulair to treat your child’s asthma,
preventing asthma symptoms during
the day and night.

Singulair 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 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 also helps prevent the narrowing of airways triggered by
exercise for patients 2 years
of age and older.
Your doctor will determine how Singulair should be used depending on
the symptoms and severity of
your child's asthma.
WHAT IS ASTHMA

Характеристики продукта

Health Products Regulatory Authority
14 May 2020
CRN009RQ4
Page 1 of 9
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.
_ _
Excipients with known effect: This medicine contains 1.2 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, oval, bi-convex-shaped, SINGULAIR engraved on one side and MSD
711 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 2 to 5year 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 Paediatricmay 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. For children who have problems consuming a
chewable tablet, a granule formulation is available (see Singulair
Paediatric 4 mg granule SmPC). The recommended dose 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 Paediatric should be ta