Denk-Air Junior 5mg tablets chewable

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

montelukast (montelukast sodium)

Commercializzato da:

Denk Pharma GmbH & Co. KG

Codice ATC:

R03DC03

INN (Nome Internazionale):

montelukast (montelukast sodium)

Dosaggio:

5mg

Forma farmaceutica:

tablets chewable

Confezione:

(28/2x14/) In blister

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2022-11-03

Foglio illustrativo

_Denk-Air Junior 5 mg_
For children 6 to 14 years of age
Chewable tablet – oral use
Leukotriene receptor antagonist
Active substance: montelukast
Package leaflet: Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU/YOUR
CHILD START/STARTS 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/your child get/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 DENK-AIR JUNIOR 5 MG IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE DENK-AIR JUNIOR 5 MG
3.
HOW TO TAKE DENK-AIR JUNIOR 5 MG
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DENK-AIR JUNIOR 5 MG
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Denk-Air Junior 5 mg is and what it
is used for
What Denk-Air Junior 5 mg is
Denk-Air Junior 5 mg is a medicine that blocks the binding
of certain inflammatory mediators (leukotrienes).
How Denk-Air Junior 5 mg works
Leukotrienes cause narrowing and swelling of the air-
ways in the lungs. By blocking the leukotrienes, Denk-Air
Junior 5 mg alleviates the symptoms of asthma, and helps
to control asthma.
When Denk-Air Junior 5 mg should be used
The doctor has prescribed Denk-Air Junior 5 mg for you or
your child so as to prevent symptoms of asthma occurring
during the day and night.
•
Denk-Air Junior 5 mg is used in paediatric patients 6
to 14 years of age whose asthma symptoms could not
be adequately controlled by previous medication and
who require an additional medical treatment.
•
Denk-Air Junior 5 mg can also be used in patients 6 to
14 years of age instead of inhalations containing cor
-
tisone (inhaled cortic

Scheda tecnica

*ALL STATEMENTS MADE UNDER "DENK-AIR" APPLY - WHERE NOT OTHERWISE
APPARENT FROM THE CONTEXT -
TO DENK-AIR 10 MG, DENK-AIR JUNIOR 4 MG AND DENK-AIR JUNIOR 5 MG.
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
Denk-Air Junior 4 mg
Denk-Air Junior 5 mg
Denk-Air 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: montelukast
_Denk-Air Junior 4 mg: _
Each chewable tablet contains 4 mg of montelukast (as montelukast
sodium).
Excipients with known effect: aspartame and sodium.
_Denk-Air Junior 5 mg: _
Each chewable tablet contains 5 mg of montelukast (as montelukast
sodium).
Excipients with known effect: aspartame and sodium.
_Denk-Air 10 mg: _
Each film-coated tablet contains 10 mg of montelukast (as montelukast
sodium).
Excipients with known effect: aspartame, sodium and sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Denk-Air Junior 4 mg: _
Chewable tablet.
Pink, flat, round, chewable tablets with beveled edges, with embossing
“4” on one side and plain on
the other.
_Denk-Air Junior 5 mg: _
Chewable tablet.
Pink, flat, round, chewable tablets with beveled edges.
_Denk-Air 10 mg: _
Film-coated tablet.
Beige, round, biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DENK-AIR*
is indicated in the treatment of asthma as add-on therapy in patients
2 years of age and
over with mild to moderate persistent asthma who are inadequately
controlled on inhaled
corticosteroids and in whom “as-needed” short acting
β-symphatomimetics provide inadequate
clinical control of asthma.
2
Denk-Air may also be an alternative treatment option to low-dose
inhaled corticosteroids for 2 to 14
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).
In patients 15 years of age and over for whom Denk-Air° is indicated
in asthma, Denk-Air 10 mg fi