Singulair 10 mg film-coated tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Montelukast

Доступна з:

LTT Pharma Limited

Код атс:

R03DC; R03DC03

ІПН (Міжнародна Ім'я):

Montelukast

Дозування:

10 milligram(s)

Фармацевтична форма:

Film-coated tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Leukotriene receptor antagonists; montelukast

Статус Авторизація:

Authorised

Дата Авторизація:

2014-02-28

інформаційний буклет

SINGULAIR 10MG FILM-COATED TABLETS
(montelukast)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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:
What Singulair is and what it is used for
What you need to know before you take Singulair
How to take Singulair
Possible side effects
How to store Singulair
Contents of the pack and other information
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 disease.
Asthma includes:
*
difficulty breathing because of na

Характеристики продукта

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: Lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Poland_
Beige, rounded square, film-coated, size 7.9 mm x 7.9 mm with
SINGULAIR engraved on one side, MSD 117 on the
other.
4 CLINICAL PARTICULARS
As per PA1286/046/004
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/046/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Hydroxypropylcellulose (E 463)
Magnesium stearate
Film coating:
Hypromellose
Hydroxypropylcellulose (E 463)
Titanium dioxide (E 171)
Red ferric oxide (E 172)
Yellow ferric oxide (E 172)
Carnauba wax
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for 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
Packaged i