Singulair 10 mg film-coated tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Montelukast sodium

থেকে পাওয়া:

Merck Sharp & Dohme Ireland (Human Health) Limited

এটিসি কোড:

R03DC; R03DC03

INN (আন্তর্জাতিক নাম):

Montelukast sodium

ডোজ:

10 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Film-coated tablet

প্রশাসন রুট:

oral use

প্যাকেজ ইউনিট:

7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

থেরাপিউটিক গ্রুপ:

Leukotriene receptor antagonist

থেরাপিউটিক এলাকা:

Leukotriene receptor antagonists; montelukast

থেরাপিউটিক ইঙ্গিত:

It 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.

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1998-02-20

তথ্য লিফলেট

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

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
14 May 2020
CRN009RQ4
Page 1 of 8
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.
_ _
Excipients with known effect: This medicine contains 89.3 mg lactose
monohydrate per tablet.
This medicine contains less than 1 mmol sodium (23mg) per tablet, that
is to say essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Beige, rounded square, film-coated, size 7.9 mm x 7.9 mm with
SINGULAIR engraved on one side and 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 β -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
Posology
The recommended dose for adults and adolescents 15 years of age and
older with asthma, or with asthma and concomitant
seasonal allergic rhinitis, is one 10mg 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 fo