Montelukast 10mg tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Montelukast sodium

Доступно од:

Torrent Pharma (UK) Ltd

АТЦ код:

R03DC03

INN (Међународно име):

Montelukast sodium

Дозирање:

10mg

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 03030200; GTIN: 5060623370367

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST 10 MG TABLETS
For adolescents and adults from 15 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.
-
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness
are the same as yours.
-
If you 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 Montelukast tablets are and what they are used for
2.
What you need to know before you take Montelukast tablets
3.
How to take Montelukast tablets
4.
Possible side effects
5.
How to store Montelukast tablets
6.
Contents of the pack and other information 1.
WHAT MONTELUKAST TABLETS ARE AND WHAT THEY ARE
USED FOR
WHAT MONTELUKAST TABLETS ARE
Montelukast tablets are a leukotriene receptor antagonist that
blocks substances called leukotrienes.
HOW MONTELUKAST TABLETS WORKS
Leukotrienes cause narrowing and swelling of airways in the lungs
and
also
cause
allergy
symptoms.
By
blocking
leukotrienes,
Montelukast
tablets
improve
asthma
symptoms,
help
control
asthma and improve seasonal allergy symptoms (also known as
hay fever or seasonal allergic rhinitis).
WHEN MONTELUKAST TABLETS SHOULD BE USED
Your doctor has prescribed Montelukast tablets to treat asthma,
preventing your asthma symptoms during the day and night.
-
Montelukast tablets are used for the treatment of adults and
adolescents 15 years of age and older who are not adequately
controlled on their medication and need additional therapy.
-
Montelukast tablets also help prevent the narrowing of airways
triggered by exercise.
-
In those asthmatic patients in whom Montelukast tablets are
indicated in asthma, Montelukast tablets can also provide
symptomatic relief of seasonal allerg

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Montelukast 10 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10.4 mg montelukast sodium which corresponds to
10 mg
montelukast.
Excipients with known effect:
Montelukast 10 mg tablet
contains 0.75 mg aspartame in each tablet.
Montelukast 10 mg tablet
contains less than 1 mmol (23 mg) of sodium per tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Light brown coloured, round biconvex shaped, uncoated tablet, with
breakline on
both sides.
The tablet can be divided into equal doses.
4.1
THERAPEUTIC INDICATIONS
Montelukast is indicated in the treatment of asthma as add-on therapy
in those
patients from 15 years of age 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.
In those asthmatic patients in whom Montelukast is indicated in
asthma, Montelukast
can also provide symptomatic relief of seasonal allergic rhinitis.
Montelukast 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 adults and adolescents 15 years of age and
older
with asthma, or with asthma and concomitant seasonal allergic
rhinitis, is one
10-mg tablet daily to be taken in the evening.
General recommendations
The therapeutic effect of Montelukast on parameters of asthma control
occurs
within one day. Montelukast tablets may be taken with or without food.
Patients should be advised to continue taking Montelukast even if
their asthma
is under control, as well as during periods of worsening asthma.
Montelukast
should not be used concomitantly with other products containing the
same
active ingredient, montelukast.
No dosage adjustment is necessary for the elderly, or for patients
with renal
insufficiency, or mild to moderate hepatic im