SINGULAIR 10mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Montelukast

Available from:

Imbat Limited

ATC code:

R03DC; R03DC03

INN (International Name):

Montelukast

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Leukotriene receptor antagonists; montelukast

Authorization status:

Authorised

Authorization date:

2013-07-26

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR
® 10MG FILM-COATED TABLETS
(montelukast)
Your medicine is available using the above name but will be
referred to as Singulair throughout this leaflet.
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.
Contents of the pack and other 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 narrowed airways.
This n

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SINGULAIR 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains montelukast sodium equivalent to 10mg
montelukast.
Also contains: lactose monohydrate
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product sourced from Poland:_
Beige, rounded square, film-coated tablets marked with ‘SINGULAIR’
on one side and ‘MSD 117’ on the other.
4 CLINICAL PARTICULARS
As per PA0035/085/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0035/085/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Hyprolose (E463)
Magnesium stearate
Film coating:
Hypromellose
Hyprolose (E463)
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)
Carnauba wax
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister strips and outer carton of the product as
marketed in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C. Store in the original package in order to
protect from light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 28 tablets.
6.6 SPECIAL PRECAUTIO