Montelukast AMETAS 10 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

MONTELUKAST NATRIUM 10,4 mg/stuk SAMENSTELLING overeenkomend met ; MONTELUKAST 10 mg/stuk

Beschikbaar vanaf:

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

INN (Algemene Internationale Benaming):

MONTELUKAST NATRIUM 10,4 mg/stuk SAMENSTELLING overeenkomend met ; MONTELUKAST 10 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

ASPARTAAM (E 951) ; BANANENSMAAKSTOF ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; PROPYLEENGLYCOL (E 1520) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND) (E 1440), ASPARTAAM (E 951) ; BANANENSMAAKSTOF ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; PROPYLEENGLYCOL (E 1520) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST AMETAS 10 MG FILMOMHULDE TABLETTEN
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 [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 and
also cause allergy
symptoms. By blocking leukotrienes, [Product Name] improves asthma
symptoms, helps con-
trol asthma and improves seasonal allergy symptoms (also known as hay
fever or seasonal
allergic rhinitis).
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 adults and adolescents 15
years of age and
older who are not adequately controlled on their medication and need
additional therapy.
•
[Product Name] also helps prevent the narrowing of airways triggered
by exercise.
•
In those asthmatic patients in whom [Product Name] is indicated in
asthma, [Product
Name] can also provide symptomatic relief of seasonal allergic
rhinitis.
Your doctor will determine how [Product Name] should be used depending
on the sympt

Productkenmerken

1_ _
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Montelukast AMETAS 10 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains montelukast sodium, which is
equivalent to 10 mg monte-
lukast.
Excipient with known effect: This medicine contains 1.5 mg aspartame
per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Beige, round, biconvex, film-coated tablets, 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. In those asthmatic patients in whom [Product Name] is
indicated in asthma,
[Product Name] can also provide symptomatic relief of seasonal
allergic rhinitis.
[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 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 [Product Name] on parameters of asthma
control occurs within one
day. [Product Name] may be taken with or without food. Patients should
be advised to
continue taking [Product Name] even if their asthma is under control,
as well as during
periods of worsening asthma. [Product Name] should not be used
concomitantly with other
products containing the same active ingredient, montelukast.
2_ _
No dosage adjustment is necessary for the elderly, or for patients
with renal insufficiency, or
mild to moderate hepatic impairment. There are no data on patients
with severe hepatic
impairment. The dos