MONTELUKAST PENSA 5 Milligram Tablets Chewable

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

MONTELUKAST SODIUM

थमां उपलब्ध:

Pensa Pharma AB

INN (इंटरनेशनल नाम):

MONTELUKAST SODIUM

डोज़:

5 Milligram

फार्मास्यूटिकल फॉर्म:

Tablets Chewable

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

0000-00-00

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER 

Montelukast Pensa 5 mg chewable tablets 
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, please 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 Montelukast Pensa is and what it is used for 
2. 
What you need to know before you take 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 doctor has prescribed Montelukast Pensa to treat asthma,
preventing your asthma symptoms 
during the day and night.  
- Montelukast Pensa is used for the treatment of 6 – 14
years old patients who are not adequately 
controlled on their medication and need additional therapy.  
- Montelukast Pensa may also be used as an alternative treatment to
inhaled corticosteroids for 6 – 14 
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
triggered by exercise.  

Your doctor will determi

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Montelukast Pensa 5mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 5.20 mg of montelukast sodium, which is equivalent to 5 mg of montelukast.
Excipients with known effect:
Each chewable tablet contains 3.00 mg of aspartame.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
The 5 mg chewable tablets are pink and biconvex with the code M5 engraved on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Montelukast Pensa 5 mg chewable tablets is indicated in children and adolescents from 6 to 14 years of age for the
treatment of asthma as add-on therapy in those 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 5 mg chewable tablets may also be an alternative treatment option to low-dose inhaled
corticosteroids for 6 to 14 years 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 5 mg chewable tablets is also indicated in the prophylaxis of asthma for 6 to 14 years old patients in
which the predominant component is exercise-induced bronchoconstriction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The dosage for paediatric patients 6-14 years of age is one 5 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 after food. No dosage
adjustment wi