Montelukast 4 mg chewable tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Montelukast

Verfügbar ab:

KRKA, d.d., Novo mesto

ATC-Code:

R03DC; R03DC03

INN (Internationale Bezeichnung):

Montelukast

Dosierung:

4 milligram(s)

Darreichungsform:

Chewable tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Leukotriene receptor antagonists; montelukast

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2010-10-22

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST 4 MG CHEWABLE TABLETS
FOR CHILDREN FROM 2 TO 5 YEARS
montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING THIS
MEDICINE TO YOUR CHILD BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
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 Montelukast is and what it is used for
2.
What you need to know before your child takes Montelukast
3.
How to take Montelukast
4.
Possible side effects
5.
How to store Montelukast
6.
Contents of the pack and other information
1.
WHAT MONTELUKAST
IS AND WHAT IT IS USED FOR
WHAT MONTELUKAST IS
Montelukast is a leukotriene receptor antagonist that blocks
substances called leukotrienes.
HOW MONTELUKAST WORKS
Leukotrienes cause narrowing and swelling of airways in the lungs. By
blocking leukotrienes,
Montelukast improves asthma symptoms and helps control asthma.
WHEN MONTELUKAST SHOULD BE USED
Your doctor has prescribed Montelukast to treat your child’s asthma,
preventing asthma symptoms
during the day and night.
-
Montelukast is used for the treatment of 2 to 5 year old patients who
are not adequately
controlled on their medication and need additional therapy.
-
Montelukast 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.
-
Montelukast also helps prevent the narrowing of airways triggered by
exercise for patients 2
years of age and older.
Your doctor will determine how Montelukast should be used depending on
the s

Fachinformation

Health Products Regulatory Authority
04 March 2024
CRN00F5KS
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Montelukast 4 mg chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 4 mg montelukast (as montelukast
sodium).
Excipient(s) with known effect:
Each chewable tablet contains 1.2 mg aspartame.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Pink, marbled, round, slightly biconvex tablets with bevelled edges
and inscription 4 on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Montelukast is indicated in the treatment of asthma as add-on therapy
in those 2 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.
Montelukast 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)
Montelukast 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 2-5 years of age is one 4
mg chewable tablet daily to be taken in the evening. If
taken in connection with food, Montelukast 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 Montelukast on parameters of asthma control
occurs within one day. Patients should be advised to
continue taking Montelukast even if their asthma is under control, as
well