Montelukast AMETAS 5 mg kauwtabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

MONTELUKAST NATRIUM 5,2 mg/stuk SAMENSTELLING overeenkomend met ; MONTELUKAST 5 mg/stuk

Beschikbaar vanaf:

AMETAS medical GmbH Christophstrasse 6-8 09212 LIMBACH-OBERFROHNA (DUITSLAND)

INN (Algemene Internationale Benaming):

MONTELUKAST NATRIUM 5,2 mg/stuk SAMENSTELLING overeenkomend met ; MONTELUKAST 5 mg/stuk

farmaceutische vorm:

Kauwtablet

Samenstelling:

ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; IJZEROXIDE ROOD (E 172) ; KERSENSMAAKSTOF ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; PROPYLEENGLYCOL (E 1520), ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; IJZEROXIDE ROOD (E 172) ; KERSENSMAAKSTOF ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; PROPYLEENGLYCOL (E 1520)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST AMETAS 5 MG KAUWTABLETTEN
Montelukast
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.
WHAT IS IN THIS LEAFLET:
1.
What [Product Name] is and what it is used for
2.
What you need to know before you take [Product Name]
3.
How to take [Product Name]
4.
Possible side effects
5.
How to store [Product Name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
WHAT [PRODUCT NAME] IS
[Product
Name]
is
a
leukotriene
receptor
antagonist
that
blocks
substances
called
leukotrienes.
HOW [PRODUCT NAME] WORKS
Leukotrienes cause narrowing and swelling of airways in the lungs. By
blocking leukotrienes,
[Product Name] improves asthma symptoms and helps control asthma.
WHEN [PRODUCT NAME] SHOULD BE USED
Your
doctor
has
prescribed
[Product
Name]
to
treat
asthma,
preventing
your
asthma
symptoms during the day and night.
•
[Product Name] 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.
•
[Product Name] 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.
•
[Product Name] also helps prevent the narrowing of airways triggered
by exercise.
Your doctor will determine how [Product Name] should be us

Productkenmerken

1_ _
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Montelukast AMETAS 5 mg kauwtabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains montelukast sodium, which is equivalent
to 5 mg montelukast.
Excipient with known effect: This medicine contains 0.743 mg aspartame
per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
Pink, flat round, chewable tablets with beveled edges, with a nominal
diameter of 8.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product Name] 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 cortico-
steroids and in whom “as-needed” short-acting β-agonists provide
inadequate clinical control
of asthma.
[Product Name] may also be an alternative treatment option to low-dose
inhaled corticoster-
oids 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).
[Product Name] 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,
[Product Name] should be
taken 1 hour before or 2 hours after food. No dosage adjustment within
this age group is
necessary.
General recommendations
2_ _
The therapeutic effect of [Product Name] on parameters of asthma
control occurs within one
day. Patients should be advised to continue taking [Product Name] 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