Singulair

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Montelukast sodium 4.16mg Equivalent to 4 mg montelukast free acid

Disponibil de la:

Merck Sharp & Dohme (New Zealand) Limited

INN (nume internaţional):

Montelukast sodium 4.16 mg (Equivalent to 4 mg montelukast free acid)

Dozare:

4 mg

Forma farmaceutică:

Chewable tablet

Compoziție:

Active: Montelukast sodium 4.16mg Equivalent to 4 mg montelukast free acid Excipient: Aspartame Cherry flavour 181612 Croscarmellose sodium Hyprolose Iron oxide red Magnesium stearate Mannitol Microcrystalline cellulose Purified water

Unități în pachet:

Blister pack, aluminium, sample pack, 4 tablets

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

MSD International GmbH (Ireland)

Indicații terapeutice:

Indicated in adult and paediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day- and nighttime symptoms and the prevention of exercise-induced bronchospasm.

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, aluminium, sample pack - 4 tablets - 24 months from date of manufacture stored at or below 30°C protect from light - Blister pack, aluminium, sample pack - 7 tablets - 24 months from date of manufacture stored at or below 30°C protect from light - Blister pack, aluminium - 28 tablets - 24 months from date of manufacture stored at or below 30°C protect from light

Data de autorizare:

2000-03-30

Prospect

NEW ZEALAND CONSUMER MEDICINE INFORMATION
SINGULAIR
®
_montelukast sodium _
4 mg, 5 mg & 10 mg tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about SINGULAIR. It does
not contain all
the available information. It does not take the place of talking to
your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
SINGULAIR against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT SINGULAIR IS USED FOR
SINGULAIR is used to treat:
•
asthma, including preventing asthma symptoms during the day and night.
It also
prevents the narrowing of airways triggered by exercise.
•
seasonal and year-round allergies, including daytime and nighttime
symptoms,
including nasal congestion, runny nose, nasal itching, and sneezing;
nasal congestion
upon awakening, difficulty going to sleep, and nighttime awakenings;
tearing, itchy, red,
and puffy eyes.
SINGULAIR can be used in children 2 years of age and older, teenagers
and adults.
SINGULAIR tablets are not used to treat an ACUTE attack of asthma. If
an acute attack
occurs, follow your doctor’s instructions for that situation.
Asthma is a lung disease and has the following characteristics:
•
narrowed airways causing breathing to become difficult
•
inflamed airways, which means the lining of airways become swollen
•
sensitive airways that react to many things, such as cigarette smoke,
pollen, or cold air.
Symptoms of asthma include coughing, wheezing and chest tightness. Not
all people with
asthma wheeze. For some, coughing may be the only symptom of asthma.
Symptoms
often occur during the night or after exercise.
Seasonal allergies (also known as hay fever) are triggered by outdoor
allergens such as
airborne pollens from trees, grasses and weeds.
Year-round allergies may occur year-round and are generally triggered
by indoor allergens
such as d

Caracteristicilor produsului

NEW ZEALAND DATA SHEET
NAME OF MEDICINE
SINGULAIR
®
montelukast sodium
10 mg tablet
5 mg chewable tablet
4 mg chewable tablet
PRESENTATION
10 mg tablet: A beige rounded square film-coated tablet engraved with
SINGULAIR on
one side and MSD117 on the other, containing 10.4 mg of montelukast
sodium which is
the molar equivalent of 10.0 mg of free acid. Dimensions: 7.87 x 7.87
mm.
5 mg chewable tablet: A pink round biconvex chewable tablet with a
cherry flavour
engraved SINGULAIR on one side and MSD275 on the other, containing 5.2
mg of
montelukast sodium which is the molar equivalent of 5.0 mg of free
acid. Dimensions:
9.525 mm diameter.
4 mg chewable tablet: A pink oval biconvex tablet with a cherry
flavour engraved
SINGULAIR on one side and MSD 711 on the other, containing 4.2 mg
montelukast
sodium which is the molar equivalent of 4.0 mg of free acid.
THERAPEUTIC CLASS
SINGULAIR (montelukast sodium) is a selective and orally active
leukotriene receptor
antagonist that specifically inhibits cysteinyl leukotriene CysLT
1
receptor.
INDICATIONS
SINGULAIR is indicated in adult and paediatric patients 2 years of age
and older for the
prophylaxis and chronic treatment of asthma, including the prevention
of day- and night-
time symptoms and the prevention of exercise-induced bronchospasm.
SINGULAIR is indicated in adults and paediatric patients 2 years of
age and older for the
relief of daytime and nighttime symptoms of seasonal allergic rhinitis
and perennial allergic
rhinitis.
DOSAGE AND ADMINISTRATION
SINGULAIR should be taken once daily. For asthma, the dose should be
taken in the
evening. For allergic rhinitis, the time of administration may be
individualised to suit
patient needs.
Patients with both asthma and allergic rhinitis should take only one
tablet daily in the
evening.
SINGULAIR Tablets Datasheet A160603v9
Page 1 of 11
ADULTS 15 YEARS OF AGE AND OLDER WITH ASTHMA AND/OR ALLERGIC RHINITIS
The dosage for adults 15 years of age and older is one 10 mg tablet
daily.
PAEDIATRIC PATIENTS 6 TO 14 YEARS OF AGE WITH