Montelukast 5mg chewable tablets sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Montelukast sodium

Available from:

Krka UK Ltd

ATC code:

R03DC03

INN (International Name):

Montelukast sodium

Dosage:

5mg

Pharmaceutical form:

Chewable tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03030200; GTIN: 5391512452032

Patient Information leaflet

What is in this leaflet
1. What Montelukast is and what it is used for
2.
What you need to know before you give
Montelukast to your child
3.
How to take Montelukast
4.
Possible side effects
5.
How to store Montelukast
6.
Contents of the pack and other information
1. WHAT MonTelukAsT Is AnD
WHAT IT Is useD FoR
Montelukast is a leukotriene receptor antagonist that
blocks substances called leukotrienes. Leukotrienes
cause narrowing and swelling of airways in the lungs.
By blocking leukotrienes, Montelukast improves
asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast to treat your
child’s asthma, preventing asthma symptoms during
the day and night.
•
Montelukast 5 mg chewable tablets are used for
the treatment of 6 to 14 year old patients who are
not adequately controlled on their medication and
need additional therapy.
•
Montelukast 5 mg chewable tablets 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.
•
Montelukast 5 mg chewable tablets also help
prevent the narrowing of airways triggered by
exercise for 6 year old patients and older.
Your doctor will determine how Montelukast should be
used depending on the symptoms and severity of your
child’s asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
•
difficulty breathing because of narrowed airways.
This narrowing of airways worsens and improves
in response to various conditions.
•
sensitive airways that react to many things, such
as cigarette smoke, pollen, or cold air, or exercise.
•
swelling (inflammation) in the lining of airways.
Symptoms of asthma include: Coughing, wheezing,
and chest tightness.
2. WHAT you neeD To knoW beFoRe
you gIve MonTelukAsT To youR
cHIlD
Tell your doctor about any medical problems or
allergies your child has now or has had.
Do not give Montelukast to your child:
•
if your child is allerg

Summary of Product characteristics

OBJECT 1
MONTELUKAST 5 MG CHEWABLE TABLETS
Summary of Product Characteristics Updated 23-May-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Montelukast 5 mg chewable tablets
2. Qualitative and quantitative composition
Each chewable tablet contains 5 mg montelukast (as montelukast
sodium).
Excipient(s) with known effect:
Each chewable tablet contains 1.5 mg aspartame.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Chewable tablet.
Pink, marbled, round, slightly biconvex tablets with bevelled edges
and inscription 5 on one side.
4. Clinical particulars
4.1 Therapeutic indications
Montelukast is indicated in the treatment of asthma as add-on therapy
in those 6 to 14 year old children
with mild to moderate persistent asthma who are inadequately
controlled on inhaled corticosteroids and in
whom 'as-needed' short-acting beta-agonists provide inadequate
clinical control of asthma.
Montelukast may also be an alternative treatment option to low-dose
inhaled corticosteroids for 6 to 14
year old children 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 6
years of age and older children in
which the predominant component is exercise-induced
bronchoconstriction.
4.2 Posology and method of administration
Posology
_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 mild to moderate hepatic
impairment. There are no data on patients with severe hepatic
impairment. The dosage is the same for
both male and female patients.
_Montelukast as an alternative treatment option