MONTELUKAST PENSA 4 Milligram Tablets Chewable

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

MONTELUKAST SODIUM

Dostupné z:

Pensa Pharma AB

INN (Medzinárodný Name):

MONTELUKAST SODIUM

Dávkovanie:

4 Milligram

Forma lieku:

Tablets Chewable

Typ predpisu:

Product subject to prescription which may be renewed (B)

Stav Autorizácia:

Authorised

Dátum Autorizácia:

0000-00-00

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER 

Montelukast Pensa 4 mg chewable tablets 
Montelukast  

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING
THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION. 
• 
Keep this leaflet. You may need to read it again. 
• 
If you have any further questions, please ask your child´s 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. 
• 
If you get any side effects, talk to your child´s doctor or
pharmacist. This includes any possible 
side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET: 
1. 
What Montelukast Pensa is and what it is used for 
2. 
What you need to know before your child takes Montelukast Pensa 
3. 
How to take Montelukast Pensa 
4. 
Possible side effects 
5. 
How to store Montelukast Pensa 
6. 
Contents of the pack and other information 

1. WHAT 
Montelukast Pensa IS AND WHAT IT IS USED FOR 

Montelukast Pensa is a leukotriene receptor antagonist that blocks
substances called leukotrienes. 
Leukotrienes cause narrowing and swelling of airways in the lungs.
By blocking leukotrienes, 
Montelukast Pensa improves asthma symptoms and helps control asthma.

Your child´s doctor has prescribed Montelukast Pensa to treat your
child´s asthma, preventing the 
asthma symptoms during the day and night.  
- Montelukast Pensa is used for the treatment of 2 to 5 years
old patients who are not adequately 
controlled on their medication and need additional therapy.  
- Montelukast Pensamay also be used as an alternative treatment
to inhaled corticosteroids for 2 to 5 
years old patients who have not recently taken oral corticosteroids
for their asthma and have shown 
that they are unable to use inhaled corticosteroids.  
- Montelukast Pensa also helps prevent the narrowing of airways
trig

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Montelukast Pensa 4mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 4.16 mg of montelukast sodium, which is equivalent to 4 mg of montelukast.
Excipients with known effect:
Each chewable tablet contains 2.40 mg of aspartame.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
The 4 mg chewable tablets are pink and biconvex with the code M4 engraved on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Montelukast Pensa 4 mg chewable tablets 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 -agonists provide inadequate clinical control of asthma.
Montelukast Pensa 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)
Montelukast Pensa 4 mg chewable tablets is also indicated in the prophylaxis of asthma for 2 to 5 year old patients 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 dosage 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, Montelukast Pensa
should be taken 1 hour before or 2 hours af