Montelukast 4mg chewable tablets sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Montelukast sodium

Available from:

Accord-UK Ltd

ATC code:

R03DC03

INN (International Name):

Montelukast sodium

Dosage:

4mg

Pharmaceutical form:

Chewable tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03030200; GTIN: 5055565705544

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST 4 MG CHEWABLE TABLETS
For children from 2 to 5 years
Montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for your child. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as your child’s.
-
If any of the side effects gets serious, talk to your doctor or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Montelukast chewable tablet 4 mg is and what it is used for
2.
What you need to know before you take Montelukast chewable tablet 4 mg
3.
How to take Montelukast chewable tablet 4 mg
4.
Possible side effects
5.
How to store Montelukast chewable tablet 4 mg
6.
Contents of the pack and other information
1. WHAT MONTELUKAST CHEWABLE TABLET 4 MG IS AND WHAT IT IS USED FOR
Montelukast
chewable
tablet
is
a
leukotriene
receptor
antagonist
that
blocks
substances
called
leukotrienes.
Leukotrienes cause narrowing and swelling of airways in your lungs. By
blocking leukotrienes, Montelukast chewable
tablet improves asthma symptoms and helps control asthma.
Your doctor has prescribed, Montelukast chewable tablet to treat your
child’s asthma, preventing asthma symptoms
during the day and night.
• Montelukast chewable tablet is used for the treatment of 2 to 5
year old patients who are not adequately controlled
on their medication and need additional therapy.
• Montelukast chewable tablet 4 mg 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.
• Montelukast chewable tablet also helps prevent the narrowing of
airways tr

Summary of Product characteristics

OBJECT 1
MONTELUKAST 4MG CHEWABLE TABLETS
Summary of Product Characteristics Updated 21-Mar-2017 | Accord
Healthcare Limited
1. Name of the medicinal product
Montelukast 4mg Chewable Tablets
For paediatric patients from 2 to 5 years
2. Qualitative and quantitative composition
Each chewable tablet contains montelukast sodium, which is equivalent
to 4 mg montelukast.
Excipient(s) with known effect:
This medicine contains 1.2mg of aspartame (E951) per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Chewable tablet Pink colored, mottled, oval, biconvex tablet, debossed
“M4” on one side and plain on
other side.
4. Clinical particulars
4.1 Therapeutic indications
Montelukast is indicated in paediatric patients aged 2 to 5years 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
beta-agonists provide inadequate clinical
control of asthma.
Montelukast may also be an alternative treatment option to low-dose
inhaled corticosteroids for 2
to5years 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)
Montelukast 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 must be administered to children under the
supervision of adults.
The recommended dose for paediatric patients 2-5 years of age is one 4
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.
The tablets are to be chewed before swallowing.
_General recommendations: _
The therap