Contains the active ingredient montelukast (as montelukast sodium)
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about montelukast. It does not contain
all the available information.
It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page.
More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you using
this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may need to read it again.
What this medicine is used for
The name of your medicine is APO-Montelukast.
It contains the active ingredient montelukast (as montelukast sodium).
It is used to:
prevent asthma symptoms, including those that occur during the day and at night-time
prevent the narrowing of airways triggered by exercise
seasonal allergic rhinitis (hay fever) symptoms.
Montelukast 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 montelukast tablets each night or as prescribed.
As a preventive medicine for asthma, montelukast 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 montelukast.
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.
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.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
How it works
Montelukast 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, montelukast improves seasonal allergic rhinitis symptoms.
There is no evidence that this medicine is addictive.
Use in children
Montelukast should not be used in children under 2 years of age.
Safety and effectiveness in children younger than 2 years of age have not been studied.
Before you take this medicine
When you must not take it
If you are not sure whether you should start taking montelukast, talk to your doctor.
Do not take this medicine if you have had an allergic reaction to montelukast or any
of the ingredients listed at the end of this leaflet. If you think you are having
an allergic reaction, contact your doctor immediately or go to the Accident and Emergency
department at the nearest hospital.
The packaging is torn, shows signs of tampering or it does not look quite right.
The expiry date (EXP) printed on the pack has passed.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
1. You have allergies to any other medicines or any other substances, such as foods,
preservatives or dyes.
2. You or your child have or have had any medical conditions.
3. You are currently pregnant or you plan to become pregnant. Do not take this medicine
whilst pregnant until you and your doctor have discussed the risks and benefits involved.
4. You are currently breastfeeding or you plan to breastfeed. Do not take this medicine
whilst breastfeeding until you and your doctor have discussed the risks and benefits
5. You are taking or are planning to take any other medicines, This includes vitamins
and supplements that are available from your pharmacy, supermarket or health food
Taking other medicines
Some medicines may affect how montelukast works, or montelukast may affect how your
other medicines work.
Tell your doctor if you are taking any other medicines, including medicines you buy
without prescription from your pharmacy, supermarket or health food shop.
How to take this medicine
Follow carefully all directions given to you by your doctor. Their instructions may
be different to the information in this leaflet.
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend
on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with
For patients with asthma and/or seasonal allergic rhinitis, take montelukast only
when prescribed by your doctor.
For patients with asthma, take montelukast once a day in the evening.
For patients with seasonal allergic rhinitis, take montelukast once a day as prescribed
by your doctor.
For children 2 to 5 years old, the dosage is one 4 mg chewable tablet taken each day.
For children 6 to 14 years old, the dosage is one 5 mg chewable tablet taken each
For adults and teenagers 15 years and older, the dose is one 10 mg tablet taken each
How to take it
Chew the 4 mg or 5 mg chewable tablets thoroughly and swallow. Do not swallow chewable
Swallow the 10 mg tablet with a glass of water.
When to take it
Take your montelukast 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 montelukast 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 montelukast at bedtime each day if you have both asthma and seasonal allergic
It does not matter if you take it before, with or after food.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
Skip the missed dose and take your next dose as usual.
Do not take a double dose to make up for missed doses.
This may increase the chance of unwanted side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately
telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia)
for advice. Alternatively go to the Accident and Emergency Department at your nearest
Do this even if there are no signs of discomfort or poisoning. You may need urgent
The most common symptoms reported with overdose in adults and children include thirst,
sleepiness, dilated pupils, hyperactivity, and stomach pain.
While you are taking this medicine
Things you must do
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
your asthma gets worse while taking montelukast
you are pregnant or are planning to become pregnant
you are breastfeeding or are planning to breastfeed
Go to your doctor regularly for a check-up.
Continue taking montelukast every day as directed by your doctor, even if you have
no asthma symptoms or if you have an asthma attack.
If an acute attack of asthma occurs, follow your doctor's instructions on what reliever
medicine to use to relieve the attack.
Tell any other doctors, dentists and pharmacists who are treating you that you take
Things you must not do
If you have been prescribed the 10 mg 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.
Take montelukast to relieve an acute asthma attack. In case of an acute asthma attack,
follow your doctor's instructions on what reliever medicine to use.
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor or pharmacist tells
Stop taking your medicine, or change the dosage, without first checking with your
Possible side effects
Tell your doctor as soon as possible if you do not feel well while you are taking
montelukast or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any
of them. All medicines can have side effects. Sometimes they are serious but most
of the time they are not.
Tell your doctor or pharmacist if you notice any of the following.
This list includes the more common side effects. Mostly, these are mild:
headache, dizziness, drowsiness
feeling unusually weak or tired
upper respiratory tract infection.
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 have been reported in patients taking montelukast.
If you or your child experience these changes while taking montelukast, tell your
You should immediately inform your doctor if you or your child start to have any:
agitation, including aggressive behaviour and/or hostility (such as temper tantrums
suicidal thoughts and actions
anxiousness, depression (sad mood)
disorientation (inability to know correct time, place or person)
disturbance in attention, memory impairment
seeing, feeling or hearing things that are not there (also called hallucinations)
insomnia, dream abnormalities, difficulty sleeping
Tell your doctor immediately if you notice any of the following.
These may be serious side effects. You may need medical attention.
skin rash or itchiness
increased tendency to bleed, bruising
fast or irregular heartbeats, 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
suicidal thoughts and actions
If you experience any of the following, stop taking your medicine and contact your
doctor immediately or go to the Accident and Emergency department at your nearest
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients.
Tell your doctor if you notice any other effects.
If you think you are having an allergic reaction to montelukast, do not take any more
of this medicine and tell your doctor immediately or go to the Accident and Emergency
department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
hay fever-like symptoms.
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place, away from light, where the temperature will
stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink.
Do not leave it on a window sill or in the car. Heat and dampness can destroy some
Keep this medicine 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 or pharmacist tells you to stop taking this medicine or they have passed
their expiry date, your pharmacist can dispose of the remaining medicine safely.
What APO-Montelukast looks like
4mg chewable tablet:
Pink coloured, oval shaped, biconvex tablets, engraved with "APO" on one side and
"M 4" on the other side. The tablets may be mottled.
5 mg chewable tablet:
Pink coloured, round shaped, biconvex tablets, engraved with "APO" on one side and
"M 5" on the other side. The tablets may be mottled.
Beige coloured, rounded square shaped, biconvex film coated tablets, with engraved
"APO" on one side and "M10" on the other side.
Blister packs of 28 tablets
* Not all strengths, pack types and/or pack sizes may be available.
Each tablet contains 4 mg, 5 mg or 10mg of montelukast (as montelukast sodium) as
the active ingredient.
The 4mg and 5mg tablets also contains the following inactive ingredients:
artificial cherry flavour
iron oxide red
The 10mg tablets also contains the following inactive ingredients:
anhydrous colloidal silica
iron oxide yellow
iron oxide red and titanium dioxide
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo
The 10mg tablets contains lactose.
Australian Registration Numbers
APO-Montelukast 4 mg chewable tablet (Blister pack): AUST R 179118.
APO-Montelukast 4 mg chewable tablet (Bottle): AUST R 179111.
APO-Montelukast 5 mg chewable tablet (Blister pack): AUST R 179115.
APO-Montelukast 5 mg chewable tablet (Bottle): AUST R 179110.
APO-Montelukast 10 mg Tablet Blister pack: AUST R 170248
APO-Montelukast 10 mg Tablet Bottle: AUST R 170246
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from the
registered proprietor, Apotex Inc.
This leaflet was last updated in: