Montelukast Synthon 4 mg Kautabletten

País: Alemanha

Língua: alemão

Origem: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

Ingredientes ativos:

Montelukast-Natrium

Disponível em:

Synthon B.V. (8010015)

Código ATC:

R03DC03

DCI (Denominação Comum Internacional):

Montelukast sodium

Forma farmacêutica:

Kautablette

Composição:

Teil 1 - Kautablette; Montelukast-Natrium (27913) 4,16 Milligramm

Via de administração:

zum Einnehmen

Status de autorização:

verlängert

Data de autorização:

2012-05-31

Folheto informativo - Bula

Common Technical Document
Montelukast (as sodium) 4 mg
Chewable tablets
Document number (version): M1.3.1_03.MUT.sod.oct4.018.03.Core
Page 1 of 7
1.3.1
Package leaflet - Core
PACKAGE LEAFLET: INFORMATION FOR THE USER
[PRODUCT NAME] 4 MG CHEWABLE TABLETS
montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS 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 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 you use [Product name]
3.
How to use [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
Montelukast 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

Características técnicas

Common Technical Document
Montelukast (as sodium) 4 mg
Chewable tablets
Document number (version): M1.3.1_01.MUT.sod.oct4.018.04.Core
Page 1 of 13
1.3.1
Summary of Product Characteristics – Core
1
NAME OF THE MEDICINAL PRODUCT
[Product name] 4 mg chewable tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains montelukast sodium, which is equivalent
to 4 mg montelukast.
Excipient(s) with known effect
This medicine contains 1.2 mg aspartame (E951) per tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Chewable tablet
Pink, capsule shaped, biconvex tablets (approximately 4 x 12 x 6 mm).
The tablets are debossed
with “M9UT” and “4” on one side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
4 mg chewable tablets are 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.
4 mg chewable tablets may also be an alternative
treatment option to low-dose
inhaled corticosteroids 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).
4 mg chewable tablets are 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. For children who have
problems consuming a chewable tablet, a granule formulation is
available. The recommended dose
Common Technical Document
Montelukast (as sodium) 4 mg
Chewable tablets
Document number (version): M1.3.1_01.MUT.sod.oct4.018.04.Core
Page 2 of 13