Singulair 10 mg film-coated tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Montelukast

Доступна з:

IMED Healthcare Ltd.

Код атс:

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:

montelukast

Статус Авторизація:

Authorised

Дата Авторизація:

2012-05-11

інформаційний буклет

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 disease.
As

Характеристики продукта

Health Products Regulatory Authority
17 July 2023
CRN00DPPN
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 imported from Czech Republic and Poland:_
Beige, rounded square, film-coated with SINGULAIR engraved on one
side, MSD 117 on the other.
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.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister strips and outer carton of the product on the market
in the country of origin.
Health Products Regulatory Authority
17 July 2023
CRN00DPPN
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C.
Store in the original package in order to protect from light and
moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium blister strips in an over-labelled cardboard carton
containing 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/064/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisa