Montelukast 5mg Chewable Tablets - For paediatric patients from 6 to 14 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 5 mg

Φαρμακοτεχνική μορφή:

CHEWABLE TABLET

Σύνθεση:

MONTELUKAST 5 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Withdrawn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 5MG CHEWABLE TABLETS
For children from 6 to 14 years
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 montelukast chewable tablet 5 mg is and what it is used for
2.
What you need to know before you take montelukast chewable tablet 5 mg
3.
How to take montelukast chewable tablet 5 mg
4.
Possible side effects
5.
How to store montelukast chewable tablet 5 mg
6.
Contents of the pack and other information
1.
WHAT MONTELUKAST CHEWABLE TABLET 5 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 the 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
asthma, preventing your asthma
symptoms during the day and night.
•
Montelukast chewable tablet 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.
•
Montelukast chewable tablet 5 mg may also be used as an alternative
treatment to inhaled
corticosteroids for 6 to 14 year old patients who have not recently
taken oral cortico

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Montelukast 5mg Chewable Tablets
For paediatric patients from 6 to 14 years
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains montelukast sodium, which is equivalent
to 5 mg montelukast.
Excipient(s) with known effect:
This medicine contains 1.5 mg of aspartame (E951) per tablet.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Chewable tablet
Pink colored, mottled, round, biconvex tablet, debossed “M5” 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 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
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 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,
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 as during periods of worsening asthma.
No dosage adjustment is necessary for patients with renal
insufficiency, or mil