Singulair 10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MONTELUKAST

Available from:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ATC code:

R03DC03

INN (International Name):

MONTELUKAST 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MONTELUKAST 10 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Withdrawn

Authorization date:

2005-06-30

Patient Information leaflet

Profile:
170 x 210 x 4
Profile Revision:
G
Profile Revision Date:
161008
Dimensions (mm):
170 x 210
Black
Profile
Technical Info
Item No.:
Revision Date & No.:
Pharma Code:
MBS Job No.:
XXXXX
XXXXXX-X
XXX
350425
PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR® 10 MG
FILM-COATED TABLETS
montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
•
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. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
•
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What SINGULAIR is and what it is used for
2.
Before you take SINGULAIR
3.
How to take SINGULAIR
4.
Possible side effects
5.
How to store SINGULAIR
6.
Further information
1. WHAT SINGULAIR IS AND WHAT IT IS USED FOR
SINGULAIR 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, SINGULAIR improves asthma
symptoms, helps control asthma and improves
seasonal allergy symptoms (also known as hay fever
or seasonal allergic rhinitis).
Your doctor has prescribed SINGULAIR to treat
asthma, preventing your asthma symptoms during
the day and night.
•
SINGULAIR is used for the treatment of patients
who are not adequately controlled on their
medication and need additional therapy.
•
SINGULAIR also helps prevent the narrowing of
airways triggered by exercise.
•
In those asthmatic patients in whom SINGULAIR is
indicated in asthma, SINGULAIR can also provide
symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how SINGULAIR should
be used depending on the symptoms and severity of
your asthma.
WHAT IS ASTHMA?
Asthma is a long-term disease.
Asthma includ

Summary of Product characteristics

1 

SUMMARY OF PRODUCT CHARACTERISTICS 

2 

1. 
NAME OF THE MEDICINAL PRODUCT 

SINGULAIR 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_: Lactose monohydrate 89.3 mg per tablet 
For a full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Film-coated tablet. 

Beige, rounded square, film-coated, size 7.9 mm x 7.9 mm with
SINGULAIR engraved on one side 
and MSD 117 on the other. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

SINGULAIR is indicated in 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 SINGULAIR is indicated in asthma, SINGULAIR can
also provide symptomatic 
relief of seasonal allergic rhinitis. 

SINGULAIR is also indicated in the prophylaxis of asthma in which
the predominant component is 
exercise-induced bronchoconstriction. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

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 SINGULAIR on
parameters of asthma control 
occurs within one day. SINGULAIR may be taken with
or without food. Patients should be advised to 
continue taking SINGULAIR even if their asthma is under control,
as well as during periods of 
worsening asthma. SINGULAIR should not be used concomitantly with
other products containing the 
same active