Singulair 10mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Montelukast sodium

Հասանելի է:

Organon Pharma (UK) Ltd

ATC կոդը:

R03DC03

INN (Միջազգային անվանումը):

Montelukast sodium

Դոզան:

10mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 03030200; GTIN: 5013945140163

Տեղեկատվական թերթիկ

SINGULAIR 10MG FILM-COATED TABLETS
(montelukast sodium)
PATIENT INFORMATION LEAFLET
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.
Your medicine is called Singulair 10mg film-coated tablets but will be
referred to as Singulair throughout the leaflet.
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 a

Ապրանքի հատկությունները

OBJECT 1
SINGULAIR 10 MG TABLETS
Summary of Product Characteristics Updated 24-Dec-2015 | Merck Sharp &
Dohme Limited
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 with known effect: This medicine contains 89.3 mg lactose
monohydrate per tablet.
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 10 mg 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 for the elderly, or for patients
with renal insufficiency, or mild to
moderate hepatic impairment.