Montelair 4 mg Chewable Tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Montelukast

Disponibbli minn:

Clonmel Healthcare Ltd

Kodiċi ATC:

R03DC; R03DC03

INN (Isem Internazzjonali):

Montelukast

Dożaġġ:

4 milligram(s)

Għamla farmaċewtika:

Chewable tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Leukotriene receptor antagonists; montelukast

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2010-10-29

Fuljett ta 'informazzjoni

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

Karatteristiċi tal-prodott

Health Products Regulatory Authority
21 March 2024
CRN00F29D
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Montelair 4 mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains montelukast sodium, which is equivalent
to 4 mg montelukast.
Excipient(s) with known effect
Each chewable tablet contains 4.8 mg of aspartame (E951) and 0.45 mg
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Chewable tablet. _Pink, oval, biconvex-shaped tablets with ‘M4’
engraved on one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Montelairis 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.
Montelair 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).
Montelair is also indicated in the prophylaxis of asthma for 2 to 5
year old patients 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 montelukast
sodium 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, Montelair should be taken 1 hour before or 2 hours after food.
No dosage adjustment within this age group is necessary.
Montelair
General recommendations
The therapeutic effect of Montelair on