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Active substance(s): MONTELUKAST SODIUM

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Montelukast 10 mg tablets
For adolescents and adults from 15 years
Read all of this leaflet carefully before you start taking this
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
In this leaflet:

What Montelukast tablets are and what they are used for
Before you take Montelukast tablets
How to take Montelukast tablets
Possible side effects
How to store Montelukast tablets
Further information

Montelukast tablets are a leukotriene receptor antagonist that
blocks substances called leukotrienes. Leukotrienes cause
narrowing and swelling of airways in your lungs and also cause
allergy symptoms. By blocking leukotrienes, Montelukast tablets
improve asthma symptoms, help control asthma and improve
seasonal allergy symptoms (also known as hay fever or seasonal
allergic rhinitis).
Your doctor has prescribed Montelukast tablets to treat asthma,
preventing asthma symptoms during the day and night.
Montelukast tablets are used for the treatment of patients who
are not adequately controlled on their medication and need
additional therapy.
Montelukast tablets also help prevent the narrowing of
airways triggered by exercise.
In those asthmatic patients in whom Montelukast tablets are
indicated in asthma, Montelukast tablets can also provide
symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelukast tablets should be
used depending on the symptoms and severity of your asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
difficulty breathing because of narrowed airways. This
narrowing of airways worsens and improves in response to
various conditions.
sensitive airways that react to many things, such as cigarette
smoke, pollen, cold air, or exercise.
swelling (inflammation) in the lining of the airways.
Symptoms of asthma include: Coughing, wheezing, and chest
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic
rhinitis) are an allergic response often caused by airborne pollens
from trees, grasses and weeds. The symptoms of seasonal
allergies typically may include: stuffy, runny, itchy nose; sneezing;
watery, swollen, red, itchy eyes.
Tell your doctor about any medical problems or allergies you have
now or have had.
Do not take Montelukast tablets if you are
allergic (hypersensitive) to montelukast or any of the other
ingredients of Montelukast tablets (see section 6. Further
Take special care with Montelukast tablets
If your asthma or breathing gets worse, tell your doctor
Montelukast tablets are not meant to treat acute asthma

attacks. If an attack occurs, follow the instructions your doctor
has given for you. Always have your inhaled rescue medicine
for asthma attacks with you.
It is important that you take all asthma medications prescribed
by your doctor. Montelukast tablets should not be used
instead of other asthma medications your doctor has
prescribed for you.
Any patient on anti-asthma medicines should be aware that if
you develop a combination of symptoms such as a flu-like
illness, pins and needles or numbness of arms or legs,
worsening of pulmonary (lung) symptoms, and/or rash, you
should consult your doctor.
You should not take acetyl-salicylic acid (aspirin) or
anti-inflammatory medicines (also known as non-steroidal
anti-inflammatory drugs or NSAIDs) if they make your asthma
Use in children
For children 2 to 5 years old, Montelukast 4 mg chewable tablets
are available.
For children 6 to 14 years old, Montelukast 5 mg chewable tablets
are available.
Taking other medicines
Some medicines may affect how Montelukast tablets work, or
Montelukast tablets may affect how other medicines work.
Please tell your doctor or pharmacist if you are taking or have
recently taken other medicines, including those obtained without a
Tell your doctor if you are taking the following medicines before
starting Montelukast tablets:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other
• gemfibrozil (used for treatment of high lipid levels in plasma)
Taking Montelukast tablets with food and drink
Montelukast tablets may be taken with or without food.
Pregnancy and breast-feeding
Use in pregnancy
Women who are pregnant or intend to become pregnant should
consult their doctor before taking Montelukast tablets. Your doctor
will assess whether you can take Montelukast tablets during this
Use in breast-feeding
It is not known if Montelukast appears in breast milk. You should
consult your doctor before taking Montelukast tablets if you are
breast-feeding or intend to breast-feed.
Driving and using machines
Montelukast tablets are not expected to affect your ability to drive
a car or operate machinery. However, individual responses to
medication may vary. Certain side effects (such as dizziness and
drowsiness) that have been reported very rarely with Montelukast
tablets may affect some patients’ ability to drive or operate
Important information about some of the ingredients of
Montelukast tablets
Montelukast tablets contain aspartame, a source of phenylalanine.
May be harmful for patients with phenylketonuria. If you have
phenylketonuria (a rare, hereditary disorder of the metabolism),
you should take into account that each 10 mg tablet contains
phenylalanine (equivalent to 0.421 mg phenylalanine per 10 mg
You should take only one Montelukast tablet once a day as
prescribed by your doctor.
It should be taken even when you have no symptoms or have
an acute asthma attack.
Always take Montelukast tablets as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
To be taken by mouth. The tablet should be swallowed with a

sufficient amount of fluid (e.g. with a glass of water).
For adults 15 years of age and older:
One 10 mg tablet to be taken daily in the evening. Montelukast
10 mg tablets may be taken with or without food.
If you are taking Montelukast tablets, be sure that you do not take
any other products that contain the same active ingredient,
For children 2 to 5 years old, Montelukast 4 mg chewable tablets
are available.
For children 6 to 14 years old, Montelukast 5 mg chewable tablets
are available.
If you take more Montelukast tablets than you should
Contact your doctor immediately for advice.
There were no side effects reported in the majority of overdose
reports. The most frequently occurring symptoms reported with
overdose in adults and children included abdominal pain,
sleepiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take Montelukast tablets
Try to take Montelukast tablets as prescribed. However, if you miss
a dose, just resume the usual schedule of one tablet once daily.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Montelukast tablets
Montelukast tablets can treat your asthma only if you continue
taking them.
It is important to continue taking Montelukast tablets for as long as
your doctor prescribes. They will help control your asthma.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
Like all medicines, Montelukast tablets can cause side effects,
although not everybody gets them.
If you notice any of the following serious side effects that have
been reported with montelukast, stop taking Montelukast tablets
and contact a doctor immediately:
rash, swelling of the face, lips, tongue, and/or throat which
may cause difficulty in breathing or swallowing (severe
allergic reaction).
flu-like illness, pins and needles or numbness of arms and
legs, worsening of pulmonary symptoms and/or rash
(Churg-Strauss syndrome).
behaviour and mood related changes such as suicidal
thoughts and actions.
severe skin reactions (erythema multiforme) that may occur
without warning.
The frequency of possible side effects listed below is defined using
the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data)
Common side effects
In clinical studies the following side effects were reported:
• abdominal pain
• headache.
These were usually mild and occurred at a greater frequency in
patients treated with montelukast than placebo (a pill containing no
Additionally, while montelukast has been on the market, the
following have been reported:
upper respiratory infection (Very common)
increased bleeding tendency (Rare)
allergic reactions including rash, swelling of the face, lips,
tongue, and/or throat which may cause difficulty in breathing
or swallowing (Uncommon)
behaviour and mood related changes [dream abnormalities,
including nightmares, trouble sleeping, sleepwalking,
irritability, feeling anxious, restlessness, agitation including
aggressive behaviour or hostility, depression, (Uncommon);
tremor (Rare); hallucinations, disorientation, suicidal

thoughts and actions (Very rare)]
dizziness, drowsiness, pins and needles/numbness, seizure
palpitations (Rare)
nosebleed (Uncommon)
diarrhoea, nausea, vomiting (Common); dry mouth,
indigestion (Uncommon)
hepatitis (inflammation of the liver) (Very rare)
rash (Common); bruising, itching, hives, tender red lumps
under the skin most commonly on your shins (erythema
nodosum) , severe skin reactions (erythema multiforme) that
may occur without warning (Very rare)
joint or muscle pain, muscle cramps (Uncommon)
fever (Common); tiredness, feeling unwell, swelling
a combination of symptoms such as flu-like illness, pins and
needles or numbness of arms and legs, worsening of
pulmonary symptoms and/or rash (Churg-Strauss syndrome)
(Very rare)
Ask your doctor or pharmacist for more information about side
effects. If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
Keep out of the reach and sight of children.
Do not use Montelukast tablets after the expiry date which is stated
on the carton and blister after EXP. The expiry date refers to the last
day of that month.
This medicinal product does not require any special temperature
storage conditions. Store in the original package in order to protect
from light and moisture
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
What Montelukast tablets contain
The active substance is montelukast. Each tablet contains 10.4
mg montelukast sodium which corresponds to 10 mg of
The other ingredients are: mannitol (E421), cellulose
microcrystalline, croscarmellose sodium, magnesium
stearate, aspartame (E951), cherry flavour (Firmenich
CHERRY 501027 AP0551), iron oxide yellow (E172), iron
oxide red (E172).
What Montelukast tablets look like and contents of the pack
Montelukast 10 mg tablets are light brown coloured, round
biconvex shaped, uncoated tablet, with breakline on both sides.
Tablets are packed into Alu/Alu blisters. The blisters are packed
into cartons.
Pack sizes: 28 tablets.
Marketing Authorisation Holder and Manufacturer
Unit 4, Charlwood Court
County Oak Way
Crawley RH11 7XA
United Kingdom
Telephone: (01293) 574180
Fax: (01293) 533003
This leaflet was last approved in 02/2013.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.