Singulair Paediatric 5mg chewable tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Montelukast sodium

Disponible des:

DE Pharmaceuticals

Codi ATC:

R03DC03

Designació comuna internacional (DCI):

Montelukast sodium

Dosis:

5mg

formulario farmacéutico:

Chewable tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 03030200

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR
® PAEDIATRIC 5MG CHEWABLE TABLETS
(MONTELUKAST SODIUM)
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 yours 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.
•
The name of this medicine is SINGULAIR Paediatric 5mg chewable
tablets but will be referred to as Singulair or Singulair Paediatric
throughout the remainder of this leaflet.
•
Singulair Paediatric 5mg chewable tablets are also available in other
strengths.
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 use

Fitxa tècnica

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