LUKAIR montelukast (as sodium) 5 mg chewable tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

montelukast sodium, Quantity: 5.2 mg (Equivalent: montelukast, Qty 5 mg)

제공처:

ORGANON PHARMA PTY LTD

INN (국제 이름):

montelukast sodium

약제 형태:

Tablet, chewable

구성:

Excipient Ingredients: mannitol; hyprolose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; iron oxide red; aspartame; Flavour

관리 경로:

Oral

패키지 단위:

28 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Prophylaxis and treatment of chronic asthma in adults and children two years of age and older. Symptomatic treatment of seasonal allergic rhinitis

제품 요약:

Visual Identification: Pink, biconvex, round chewable tablet debossed with 275 on one side and plain on the other side; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

승인 상태:

Registered

승인 날짜:

2013-01-25

환자 정보 전단

LUKAIR
®
_Montelukast sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LUKAIR. 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 LUKAIR
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 LUKAIR IS USED
FOR
LUKAIR is used to prevent asthma
symptoms, including those that occur
during the day and at night-time. It
also prevents the narrowing of
airways triggered by exercise.
If you have seasonal allergic rhinitis
(hay fever), LUKAIR also treats your
allergic rhinitis symptoms.
It can be used in children 2 years of
age and older, teenagers and adults.
LUKAIR tablets are not used to treat
an acute attack of asthma. If an acute
attack occurs, follow your doctor's
instructions for your reliever
medicine, and keep taking your
LUKAIR each night or as prescribed.
As a preventive medicine for asthma,
LUKAIR can be used alone or in
combination with other preventive
medicines, such as inhaled
corticosteroids. Your doctor may
reduce your dose of inhaled
corticosteroid while you are taking
LUKAIR.
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.
For further information about
asthma, contact the Asthma
Foundation in your state on 1800 645
130, or www.asthmaaustralia.org.au
Seasonal allergic rhinitis (also known

제품 특성 요약

S-WPC-MK0476-MF-112018
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
LUKAIR
®
(MONTELUKAST SODIUM)
TABLETS
1
NAME OF THE MEDICINE
Montelukast sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg film-coated tablet contains 10.4 mg montelukast sodium,
which is equivalent to
10.0 mg of montelukast, the free acid.
Excipients with known effects:
-lactose monohydrate
Each 5 mg chewable tablet contains 5.2 mg montelukast sodium, which is
equivalent to 5.0
mg of montelukast, the free acid.
Each 4 mg chewable tablet contains 4.16 mg of montelukast sodium,
which is equivalent to
4.0 mg of montelukast, the free acid.
Excipients with known effects:
-aspartame
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
10 mg film-coated tablet - A beige, biconvex, rounded square
film-coated tablet debossed with
'117' on one side and plain on the other.
5 mg chewable tablet - A pink, biconvex, round chewable tablet
debossed with '275' on one
side and plain on the other.
4 mg chewable tablet - A pink, oval, biconvex chewable tablet debossed
with '711' on one side
and plain on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis and treatment of chronic asthma in adults and children 2
years of age and older.
Symptomatic treatment of seasonal allergic rhinitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
ASTHMA AND/OR SEASONAL ALLERGIC RHINITIS
LUKAIR should be taken once daily.
For asthma, the dose should be taken in the evening.
S-WPC-MK0476-MF-112018
Page 2 of 17
For seasonal allergic rhinitis, the time of administration may be
individualised to suit patient
needs.
Patients with both asthma and seasonal allergic rhinitis should take
only one tablet daily in the
evening.
ADULTS 15 YEARS OF AGE AND OLDER
The dosage for adults 15 years of age and older is one 10 mg tablet
daily.
PAEDIATRIC PATIENTS 6 TO 14 YEARS OF AGE
The dosage for paediatric patients 6 to 14 years of age is one 5 mg
chewable tablet daily.
Chew the tablets. Do not swallow whole.
PAEDIATRIC PATIENTS 2 TO 5 YE