Montelukast AMETAS 4 mg kauwtabletten

국가: 네덜란드

언어: 네덜란드어

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

유효 성분:

MONTELUKAST NATRIUM 4,2 mg/stuk SAMENSTELLING overeenkomend met ; MONTELUKAST 4 mg/stuk

제공처:

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

INN (International Name):

MONTELUKAST NATRIUM 4,2 mg/stuk SAMENSTELLING overeenkomend met ; MONTELUKAST 4 mg/stuk

약제 형태:

Kauwtablet

구성:

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)

관리 경로:

Oraal gebruik

승인 날짜:

1900-01-01

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST AMETAS 4 MG KAUWTABLETTEN
Montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICINE TO
YOUR CHILD BECAUSE IT
CONTAINS IMPORTANT INFORMATION.
-
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 your child only. Do not pass it
on to others. It
may harm them, even if their signs of illness are the same as your
child’s.
-
If your child gets 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 your child takes [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 your child’s
asthma, preventing asthma
symptoms during the day and night.
•
[Product Name] is used for the treatment of 2 to 5 year old patients
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 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.
•
[Product Name] also helps prevent the narrowing of airways triggered
by exercise for
patients 2 years of age and older.
Your doctor will determine how [Product Name] should be used depending

제품 특성 요약

1_ _
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Montelukast AMETAS 4 mg kauwtabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains montelukast sodium, which is equivalent
to 4 mg montelukast.
Excipient with known effect: This medicine contains 0.6 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, marked with
‘4’ on one side and plain
on the other, with a nominal diameter of 7.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product Name] is indicated in the treatment of asthma as add-on
therapy in those 2 to 5 year
old patients 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.
[Product Name] may also be an alternative treatment option to low-dose
inhaled corticoster-
oids for 2 to 5 year 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).
[Product Name] 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 is to be given to a child under adult
supervision.
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,
[Product Name] should be
taken 1 hour before or 2 hours after food. No dosage adjustment within
this age group is
2_ _
necessary. For children who have problems consuming a chewable tablet,
another pharma-
ceutical form may be more appropriate.
General recommendations
The therapeutic effect of [Product Name] on paramete