Montelukast 10mg film-coated tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

montelukast sodium

Available from:

WARREN GENERICS s.r.o

ATC code:

R03DC03

INN (International Name):

montelukast sodium

Dosage:

10mg

Pharmaceutical form:

Film-coated tablets

Administration route:

Oral use

Units in package:

7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Indoco Remedies Limited

Therapeutic group:

Drugs for obstructive airway diseases, Leukotriene receptor antagonists

Therapeutic indications:

It is indicated in the treatment of asthma as addon therapy in adolescent of 15 years of age and older and adults 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. In those asthmatic patients in whom montelukast is indicated in asthma, it can also provide symptomatic relief of seasonal allergic rhinitis.

Authorization status:

Authorised

Authorization date:

2015-03-03

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

Montelukast 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, 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 10 mg film-coated tablets is and
what it is used for 
2.  What you need to know before you take Montelukast 10
mg film-coated tablets 
3.  How to take Montelukast 10 mg film-coated tablets 
4.  Possible side effects 
5.  How to store Montelukast 10 mg film-coated tablets 
6.  Contents of the pack and other information 

1. 
WHAT MONTELUKAST
10 MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR 

Montelukast is a leukotriene receptor antagonist that blocks
substances called leukotrienes. 
Leukotrienes cause narrowing and swelling of airways in the lungs
and also cause allergy symptoms.  

By blocking leukotrienes, montelukast improves asthma symptoms,
helps control asthma and 
improves seasonal allergy symptoms (also known as hay fever or
seasonal allergic rhinitis). 

Your doctor has prescribed /.../ to treat asthma,
preventing your asthma symptoms during the day and 
night. 
•  Montelukast 10
mg film-coated tablets is used for the treatment of patients
aged 15 years and 
older who are not adequately controlled on their medication
and need additional therapy. 
•  Mon

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Montelukast 10 mg film-coated tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
One film-coated tablet contains montelukast sodium, which is
equivalent to 10 mg 
montelukast.  

Excipient with known effect: Lactose monohydrate 89.3 mg per
tablet  

For the full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 
Film-coated tablet. 

Beige coloured, rounded square, film coated, biconvex tablets
of dimension 8.1 mm x 
8.1 mm, plain on both sides. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Montelukast 10 mg film-coated tablets is indicated in the
treatment of asthma as add-
on therapy in adolescent of 15 years of age and older and
adults 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. In those asthmatic
patients in whom montelukast is 
indicated in asthma, it can also provide symptomatic relief
of seasonal allergic 
rhinitis.  

Montelukast 10 mg film-coated tablets is also indicated in the
prophylaxis of asthma 
in which the predominant component is exercise-induced
bronchoconstriction. 

Montelukast is indicated in adults and adolescents from the age
of 15 years. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 

The dosage for adults and adolescents 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
on parameters of asthma control occurs within 
one day. Montelukast tablets may be taken with or without food.
Patients should be 
advised to continue taking montelukast even if their asthma is
under control,�