SINGULAIR 10 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MONTELUKAST SODIUM

Available from:

Primecrown 2010 Ltd

ATC code:

R03DC03

INN (International Name):

MONTELUKAST SODIUM

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Leukotriene receptor antagonists

Authorization status:

Authorised

Authorization date:

2012-08-31

Patient Information leaflet

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 gets 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 includes: 

• difficulty breathing because of�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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 with known effect_: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-Coated Tablet.
_Product imported from Lithuania and Poland:_
Beige, rounded square, film-coated with SINGULAIR engraved on one side, 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 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 ingredient, montelukast.
No dosage adjustment is necessary for