Montelukast 5mg chewable tablets sugar free

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Montelukast sodium

Dostępny od:

Accord-UK Ltd

Kod ATC:

R03DC03

INN (International Nazwa):

Montelukast sodium

Dawkowanie:

5mg

Forma farmaceutyczna:

Chewable tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 03030200; GTIN: 5055565705551

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST 5 MG CHEWABLE TABLETS
For children from 6 to 14 years
Montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 you or your child. Do not pass
it on to others. It may harm them, even if
their symptoms are the same as yours.
-
If you get any 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 5 mg is and what it is used for
2.
What you need to know before you take montelukast chewable tablet 5 mg
3.
How to take montelukast chewable tablet 5 mg
4.
Possible side effects
5.
How to store montelukast chewable tablet 5 mg
6.
Contents of the pack and other information
1. WHAT MONTELUKAST CHEWABLE TABLET 5 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
or your child’s asthma, preventing asthma
symptoms during the day and night.
• Montelukast chewable tablet 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.
• Montelukast chewable tablet 5 mg 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 chewable tablet also helps prevent the narrow

Charakterystyka produktu

OBJECT 1
MONTELUKAST 5MG CHEWABLE TABLETS
Summary of Product Characteristics Updated 21-Mar-2017 | Accord
Healthcare Limited
1. Name of the medicinal product
Montelukast 5mg Chewable TabletsFor paediatric patients from 6 to 14
years
2. Qualitative and quantitative composition
Each chewable tablet contains montelukast sodium, which is equivalent
to 5 mg montelukast.
Excipient(s)with known effect:
This medicine contains 1.5 mg of aspartame(E951) per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Chewable tablet
Pink colored, mottled, round, biconvex tablet, debossed “M5” on
one side and plain on other side.
4. Clinical particulars
4.1 Therapeutic indications
Montelukastis indicated in paediatric patients aged 6 to 14 years 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.
Montelukastmay also be an alternative treatment option to low-dose
inhaled corticosteroids for 6 to 14
years 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)
Montelukastis also indicated in the prophylaxis of asthma from6 years
of age and older in which the
predominant component is exercise-induced bronchoconstriction.
4.2 Posology and method of administration
Posology
The recommended dose for paediatric patients and adolescents 6-14
years of age is one 5 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.
_General recommendations: _
The therapeutic effect of Montelukaston parameters of asthma control
occurs within one day. Patients
should be advised to continu