Singulair 4mg granules

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

MONTELUKAST

Tilgjengelig fra:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ATC-kode:

R03DC03

INN (International Name):

MONTELUKAST 4 mg

Legemiddelform:

GRANULES

Sammensetning:

MONTELUKAST 4 mg

Resept typen:

POM

Terapeutisk område:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2007-11-22

Informasjon til brukeren

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR PAEDIATRIC 4 MG GRANULES
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 Paediatric is and what it is used for
2.
What you need to know before your child takes Singulair Paediatric
3.
How to take Singulair Paediatric
4.
Possible side effects
5.
How to store Singulair Paediatric
6.
Contents of the pack and other information
1.
WHAT SINGULAIR PAEDIATRIC IS AND WHAT IT IS USED FOR
WHAT SINGULAIR PAEDIATRIC IS
Singulair Paediatric is a leukotriene receptor antagonist that blocks
substances called leukotrienes.
HOW SINGULAIR PAEDIATRIC WORKS
Leukotrienes cause narrowing and swelling of airways in the lungs. By
blocking leukotrienes,
Singulair Paediatric improves asthma symptoms and helps control
asthma.
WHEN SINGULAIR PAEDIATRIC SHOULD BE USED
Your doctor has prescribed Singulair Paediatric to treat your
child’s asthma, preventing asthma
symptoms during the day and night.

Singulair Paediatric is used for the treatment of 6 months to 5 year
old patients who are not
adequately controlled on their medication and need additional therapy.

Singulair Paediatric 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 Paediatric also helps prevent the narrowing of airways
triggered by exercise fo

Preparatomtale

Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT
SINGULAIR PAEDIATRIC 4 MG GRANULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet of granules contains montelukast sodium, which is
equivalent to 4 mg montelukast.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
GRANULES.
White granular, coarse, free-flowing, homogeneous solid with no
extraneous particles present.
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Singulair is indicated in the treatment of asthma as add-on therapy in
those 6 months 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

-agonists provide inadequate clinical control
of asthma.
Singulair 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).
Singulair 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 6 months to 5 years of age is one sachet of 4 mg
granules daily to be taken in the
evening. No dosage adjustment within this age group is necessary.
Efficacy data from clinical trials
in paediatric patients 6 months to 2 years of age with persistent
asthma are limited. Patients should
be evaluated after 2 to 4 weeks for response to montelukast treatment.
Treatment should be
discontinued if a lack of response is observed. The Singulair
Paediatric 4 mg granules formulation is
not recommended below 6 months of age.
_Administration of Singulair granules: _
Singulair granules can be administered