Singulair 10 mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Montelukast

Boleh didapati daripada:

PCO Manufacturing Ltd.

Kod ATC:

R03DC; R03DC03

INN (Nama Antarabangsa):

Montelukast

Dos:

10 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Leukotriene receptor antagonists; montelukast

Status kebenaran:

Authorised

Tarikh kebenaran:

2004-03-19

Risalah maklumat

_ _
_ _
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 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 Singulair is and what it is used for
2.
What you need to know 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
WHAT Singulair IS
Singulair is a leukotriene receptor antagonist that blocks substances
called leukotrienes.
HOW SINGULAIR WORKS
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).
WHEN SINGULAIR SHOULD BE USED
Your doctor has prescribed Singulair to treat asthma, preventing your
asthma symptoms during the day and night.
•
Singulair is used for the treatment of adults and adolescents 15
years of age and older 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 di

Ciri produk

Health Products Regulatory Authority
17 July 2023
CRN00DPP0
Page 1 of 2
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(s) with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_ _
_Product sourced from Portugal, Italy, Poland, Belgium and Czech
Republic:_
Beige, rounded square, film-coated tablet with 'SINGULAIR' engraved on
one side and 'MSD 117' on the other.
or
_ _
_Product sourced from Italy:_
Beige, rounded square, film coated tablet with '117' engraved on one
side.
4 CLINICAL PARTICULARS
As per PA23198/014/004
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/014/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Hyprolose (E 463)
Magnesium stearate
Film coating:
Hypromellose
Hyprolose (E 463)
Titanium dioxide (E 171)
Red and yellow ferric oxide (E 172)
Carnauba wax
6.2 INCOMPATIBILITIES
Not applicable
Health Products Regulatory Authority
17 July 2023
CRN00DPP0
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
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 pack of 28 tablets in a cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/111/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authoris