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
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
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 as hay fever) is an allergic response often
caused by airborne pollens from trees, grasses, and weeds. The daytime and night-time
symptoms of seasonal allergic rhinitis typically may include: stuffy, runny, itchy
nose; sneezing; watery, swollen, red, itchy eyes.
How LUKAIR works
LUKAIR belongs to a group of medicines called leukotriene receptor antagonists. It
works by blocking substances in your lungs called leukotrienes that cause narrowing
and swelling of airways. Blocking leukotrienes improves asthma symptoms and helps
prevent asthma attacks. Leukotrienes also cause allergic rhinitis symptoms. By blocking
leukotrienes, LUKAIR improves seasonal allergic rhinitis symptoms.
Your doctor may have prescribed LUKAIR for another reason. Ask your doctor if you
have any questions about why LUKAIR has been prescribed for you.
LUKAIR is not addictive.
Before you take LUKAIR
When you must not take it
Do not take LUKAIR if:
you have an allergy to LUKAIR or any of the ingredients listed at the end of this
the packaging is torn or shows signs of tampering
the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work.
If you are not sure whether you should start taking LUKAIR, talk to your doctor.
Do not give LUKAIR to children under 2 years of age.
Safety and effectiveness in children younger than 2 years of age have not been studied.
In studies investigating the effect of LUKAIR on the growth rate of children, it was
shown that LUKAIR did not affect the growth rate of children when given for up to
56 weeks in one study.
Before you start to take it
Tell your doctor if:
1. you are pregnant or intend to become pregnant
LUKAIR has not been studied in pregnant women.
2. you are breast-feeding or plan to breast-feed
It is not known if LUKAIR passes into breast milk.
3. you have or have had any medical conditions
4. your child has a condition called phenylketonuria
The 5 mg and 4 mg chewable tablets contain aspartame, corresponding to 0.842 mg phenylalanine
in each 5 mg tablet and 0.674 mg in each 4 mg tablet.
5. you have any allergies to any other medicines or any other substances, such as foods,
preservatives or dyes.
If you have not told your doctor about any of the above, tell them before you take
Taking other medicines
Some medicines may affect how LUKAIR works, or LUKAIR may affect how your other medicines
Tell your doctor if you are taking any other medicines, including medicines that you
buy without a prescription from your pharmacy, supermarket or health food shop.
How to take LUKAIR
How much to take
For patients with asthma and/or seasonal allergic rhinitis, take LUKAIR only when
prescribed by your doctor.
For adults and teenagers 15 years and older, the dose is one 10 mg film-coated tablet
taken each day.
For children 6 to 14 years old, the dose is one 5 mg chewable tablet taken each day.
For children 2 to 5 years old, the dose is one 4 mg chewable tablet taken each day.
For patients with asthma, take LUKAIR once a day in the evening.
For patients with seasonal allergic rhinitis, take LUKAIR once a day as prescribed
by your doctor.
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
How to take it
LUKAIR comes as three types of tablets:
10 mg film-coated tablets for adults and teenagers 15 years and older
5 mg chewable tablets for children 6-14 years old
4 mg chewable tablets for children 2-5 years old.
Swallow the 10 mg film-coated tablet with a glass of water.
Chew the 5 mg or 4 mg chewable tablets thoroughly and swallow. Do not swallow whole.
When to take it
Take your LUKAIR at bedtime each day.
Taking your tablet at bedtime each day is expected to have the best effect. It will
also help you remember when to take the tablets.
Seasonal allergic rhinitis:
Take your LUKAIR once a day as prescribed by your doctor.
Your doctor will advise you on the best time of the day to take your tablet.
Asthma and seasonal allergic rhinitis:
Take your LUKAIR at bedtime each day if you have both asthma and seasonal allergic
It does not matter if you take LUKAIR before or after food.
How long to take it
LUKAIR helps control your asthma. Therefore LUKAIR must be taken every day. Continue
taking LUKAIR for as long as your doctor prescribes.
If you forget to take it
Skip the dose you missed and take your next dose as usual.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your tablets, ask your pharmacist for some
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26)
for advice, if you think that you or anyone else may have taken too much LUKAIR.
Do this even if there are no signs of discomfort or poisoning.
The most common symptoms reported with overdose in adults and children include thirst,
sleepiness, dilated pupils, hyperactivity, and stomach pain.
While you are using LUKAIR
Things you must do
Continue taking LUKAIR every day as directed by your doctor, even if you have no asthma
symptoms or if you have an asthma attack.
If your asthma gets worse while taking LUKAIR, tell your doctor immediately.
If an acute attack of asthma occurs, follow your doctor's instructions on what reliever
medicine to use to relieve the attack.
If you experience behaviour and mood-related changes while taking LUKAIR, tell your
If you become pregnant while taking LUKAIR, tell your doctor immediately.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking LUKAIR.
Things you must not do
If you have been prescribed the 10 mg film-coated tablets, do not take two 5 mg chewable
tablets in its place. If you have been prescribed the 5 mg tablets, do not take half
a 10 mg tablet in its place.
The different strength tablets may not have the same effect, as they are absorbed
slightly differently in the body.
Do not take LUKAIR to relieve an acute asthma attack. In case of an acute asthma
attack, follow your doctor's instructions on what reliever medicine to use.
Do not give LUKAIR to anyone else, even if they have the same condition as you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking LUKAIR.
LUKAIR helps most people with asthma and/or seasonal allergic rhinitis, but it may
have unwanted side effects in a few people. All medicines can have side effects. Sometimes
they are serious, most of the time they are not. You may need medical treatment if
you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
headache, dizziness, drowsiness
feeling unusually weak or tired
upper respiratory tract infection
bedwetting in children
muscle or nerve problems:
muscle aches or cramps, joint pain
decreased feeling or sensitivity, especially in the skin
pins and needles
stomach or bowel problems:
Behaviour and mood-related changes, including suicidal thoughts and actions, have
been reported in patients taking montelukast. If you or your child experience these
changes while taking montelukast, tell your doctor.
Tell your doctor if you notice any of the following behaviour and mood-related changes:
agitation, including aggressive behaviour or hostility
anxiousness, depression (sad mood)
disorientation, dream abnormalities, hallucinations (seeing or hearing things that
are not there)
insomnia, irritability, restlessness, sleep walking
disturbances in attention, memory impairment
uncontrolled muscle movements
These are usually mild side effects of LUKAIR.
Tell your doctor immediately if you notice any of the following:
suicidal thoughts and actions
skin rash or itchiness
increased tendency to bleed, bruising
fast or irregular heart beats, also called palpitations
swelling (inflammation) of the lungs
symptoms of liver disease such as nausea, vomiting, loss of appetite, feeling generally
unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine
These may be serious side effects. You may need urgent medical attention. Serious
side effects are rare.
If any of the following happen, stop taking LUKAIR and tell your doctor immediately
or go to accident and emergency at your nearest hospital:
swelling of the face, lips, mouth, throat or tongue which may cause difficulty in
breathing or swallowing
pinkish, itchy swellings on the skin, also called hives or nettle rash, severe skin
reactions that may occur without warning
These may be serious side effects. If you have them, you may be having a serious allergic
reaction to LUKAIR. You may need urgent medical attention. These side effects are
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some patients. Some of these
side effects (for example, low blood platelet count) can only be detected when your
doctor does tests from time to time to check your progress.
Tell your doctor if you notice any other effects.
After using LUKAIR
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out the blister pack they may not keep well.
Keep LUKAIR in a cool dry place, away from light, where the temperature stays below
Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking the tablets, or the tablets have passed their
expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
LUKAIR comes as three types of tablets:
10 mg film-coated tablet - beige, rounded square film-coated tablet with '117' marked
on one side and plain on the other.
5 mg chewable tablet - pink, round tablet with '275' marked on one side and plain
on the other.
4 mg chewable tablet - pink, oval tablet with '711' marked on one side and plain on
A box of LUKAIR contains 28 tablets.
10 mg film-coated tablet contains 10 mg montelukast
5 mg chewable tablet contains 5 mg montelukast
4 mg chewable tablet contains 4 mg montelukast
1. 10 mg film-coated tablets
iron oxide red
iron oxide yellow
2. 5 mg and 4 mg chewable tablets
iron oxide red
artificial cherry flavour aromolok 181612 (proprietary ingredient: 2916)
LUKAIR 10 mg film-coated tablets, and 5 mg and 4 mg chewable tablets do not contain
gluten, sucrose, tartrazine or any other azo dyes. The 10 mg film-coated tablets contain
lactose monohydrate; the 5 mg and 4 mg chewable tablets do not.
LUKAIR is supplied in Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A
26 Talavera Road
Macquarie Park NSW 2113
This leaflet was prepared in January 2019.
Australian Register Numbers:
10 mg - AUST R 197285
5 mg - AUST R 197284
4 mg - AUST R 197283
This CMI leaflet was current at the time of printing.