Singulair Paediatric 5mg chewable tablets

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Montelukast sodium

Disponibbli minn:

Organon Pharma (UK) Ltd

Kodiċi ATC:

R03DC03

INN (Isem Internazzjonali):

Montelukast sodium

Dożaġġ:

5mg

Għamla farmaċewtika:

Chewable tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 03030200; GTIN: 5013945140156

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR® PAEDIATRIC 5 MG
CHEWABLE TABLETS
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 Singulair Paediatric is and what it is used for
2.
What you need to know before you take 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
asthma, preventing your asthma symptoms during the day
and night.
•
Singulair Paediatric 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.
•
Singulair Paediatric may also be used as an alternative
treatment to inhaled corticosteroids for 6 to 14 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 narr

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Singulair Paediatric
5 mg chewable tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains montelukast sodium, which is equivalent
to 5 mg
montelukast.
Excipients with known effect: This medicine contains 1.5 mg aspartame
(E
951) per tablet.
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to
say essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Chewable tablet.
Pink, round, biconvex, diameter 9.5 mm with SINGULAIR engraved on one
side and
MSD 275 on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Singulair 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.
Singulair 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).
Singulair 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,
Singulair 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 Singulair on parameters of asthma control
occurs within one
day. Patients should be advised to continue taking Singulair even if
their asthma is
under control, as well as during periods of worsening asthma.
No dosage adjustmen