MONTELUKAST PENSA 10 Milligram Film Coated Tablet

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

MONTELUKAST SODIUM

Beschikbaar vanaf:

Pensa Pharma AB

INN (Algemene Internationale Benaming):

MONTELUKAST SODIUM

Dosering:

10 Milligram

farmaceutische vorm:

Film Coated Tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Autorisatie-status:

Authorised

Autorisatie datum:

0000-00-00

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER 

Montelukast Pensa 10 mg film-coated 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, helps control asthma
and improves seasonal allergy 
symptoms (also known as hay fever or seasonal allergic rhinitis). 

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 adults and
adolescents from the age of 15 years  who 
are not adequately controlled on their medication and need additional
therapy.  
- In those asthmatic patients in whom Montelukast Pensa is
indicated in asthma, Montelukast Pensa 
can also provide symptomatic relief of seasonal allergic rhinitis.  
- Montelukast Pensa also helps prevent the narrowing of airways
triggered by exercise.  

Y

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Montelukast Pensa 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg of montelukast.
Excipients with known effect:
Each film-coated tablet contains 103.47 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
The 10 mg film-coated tablets are peach color and biconvex with the code M10 engraved on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Montelukast Pensa 10 mg film-coated tablets is indicated in adults and adolescents from the age of 15 years 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. In those asthmatic patients in whom montelukast is indicated in asthma, montelukast can also
provide symptomatic relief of seasonal allergic rhinitis.
Montelukast Pensa 10 mg film-coated tablets is also indicated in the prophylaxis of asthma in which the predominant
component is exercise-induced bronchoconstriction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The dosage for adults 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis,
is one 10 mg tablet daily to be taken in the evening.
_General recommendations_:
The therapeutic effect of Montelukast Pensa on parameters of asthma control occurs within one day.
Montelukast Pensa may be taken with or without food.
Patients should be advised to continue taking Montelukast Pensa even if their asthma is under control, as well as during