Montelukast 4mg Chewable Tablets - For paediatric patients from 2 to 5 years

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

MONTELUKAST

Διαθέσιμο από:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Φαρμακολογική κατηγορία (ATC):

R03DC03

INN (Διεθνής Όνομα):

MONTELUKAST 4 mg

Φαρμακοτεχνική μορφή:

CHEWABLE TABLET

Σύνθεση:

MONTELUKAST 4 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2011-06-02

Φύλλο οδηγιών χρήσης

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST 4MG 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
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What montelukast chewable tablet 4 mg is and what it is used for
2.
What you need to know before your child takes Montelukast chewable
tablet 4 mg
3.
How to take Montelukast chewable tablet 4 mg
4.
Possible side effects
5.
How to store Montelukast chewable tablet 4 mg
6.
Contents of the pack and other information
1.
WHAT MONTELUKAST CHEWABLE TABLET 4 MG IS AND WHAT IT IS USED FOR
What Montelukast chewable tablet is
Montelukast chewable tablet is a leukotriene receptor antagonist that
blocks substances called
leukotrienes.
How Montelukast chewable tablet works
Leukotrienes cause narrowing and swelling of airways in your lungs. By
blocking leukotrienes,
Montelukast chewable tablet improves asthma symptoms and helps control
asthma.
When Montelukast chewable tablet should be used
Your doctor has prescribed, Montelukast chewable tablet to treat your
child’s asthma, preventing
asthma symptoms during the day and night.
•
Montelukast chewable tablet 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 chewable tablet 4 mg 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

Αρχείο Π.Χ.Π.

PAGE 1 OF 13
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Montelukast 4mg Chewable Tablets
For paediatric patients from 2 to 5 years
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains montelukast sodium, which is equivalent
to 4 mg montelukast.
Excipient(s) with known effect:
This medicine contains 1.2mg of aspartame (E951) per tablet.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Chewable tablet Pink colored, mottled, oval, biconvex tablet, debossed
“M4” on one side and
plain on other 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 years 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
PAGE 2 OF 13
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 i