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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
medicine because it contains important information for you.
- 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 only. Do not pass it
on to others. It may harm them, even if their signs of illness
are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:

What Montelukast tablets are and what they are used for
What you need to know before you take Montelukast tablets
How to take Montelukast tablets
Possible side effects
How to store Montelukast tablets
Contents of the pack and other information

What Montelukast tablets are
Montelukast tablets are a leukotriene receptor antagonist that
blocks substances called leukotrienes.
How Montelukast tablets works
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).
When Montelukast tablets should be used
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 adults and
adolescents 15 years of age and older 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 to montelukast or any of the other
ingredients of this medicine (listed in section 6.).

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Warnings and precautions
Talk to you doctor or pharmacist before taking 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 or your child take all asthma
medications prescribed by your doctor. Montelukast tablets
should not be substituted for 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 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
Children and adolescents
Do not give this medicine to children less than 15 years of age
There are different form(s) of this medicine available for paediatric
patients based on age range.
Other medicines and Montelukast tablets
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines, including those obtained
without a prescription.
Some medicines may affect how Montelukast tablets works, or
Montelukast tablets may affect how other medicines work.
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)
Montelukast tablets with food
Montelukast tablets may be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before taking Montelukast tablets.
Your doctor will assess whether you can take Montelukast tablets
during this time.
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
Montelukast tablets contains aspartame
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
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

You should take only one tablet of Montelukast tablets once a
day as prescribed by your doctor.
It should be taken even when you have no symptoms or have
an acute asthma attack.

For adults and adolescents 15 years of age and older:


: 180 x 300 mm_Front/Back Side

Supersedes A /W No.:
CODE : 8062210-7803

DATE : 14-12-2016

REMARK : Folding Length 35 mm


Prepared By Pkg.Dev
Reviewed By Pkg.Dev
Approved By Quality




The recommended dose is one 10 mg tablet to be taken daily in the
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.
This medicine is for oral use.
You can take Montelukast tablets with or without food. The tablet
should be swallowed with a sufficient amount of fluid (e.g. with a
glass of water).
The tablet can be divided into equal doses.
If you take more Montelukast tablets than you should

rash (Common); bruising, itching, hives (Uncommon); 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); weakness, tiredness, feeling unwell,
swelling (Uncommon)

In asthmatic patients treated with montelukast, very rare cases of
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) have been
reported. You must tell your doctor right away if you get one or
more of these symptoms (See section 2).
Reporting of side effects

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 get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme: By reporting side effects
you can help provide more information on the safety of this

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.

Keep this medicine out of the sight and reach of children.

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 medicine, ask
your doctor or pharmacist.

Do not use this medicine 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.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.

Like all medicines, this medicines can cause side effects, although
not everybody gets them.
In clinical studies with Montelukast 10 mg tablets, the most
commonly reported side effects (occurring in at least 1 of 100
patients and less than 1 of 10 patients treated) thought to be
related to Montelukast 10 tablets were:
- abdominal pain
- headache
These were usually mild and occurred at a greater frequency in
patients treated with Montelukast 10 mg tablets than placebo (a
pill containing no medication).
The frequency of possible side effects listed below is defined using
the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
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 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, disturbance in attention, memory impairment (Rare);
hallucinations, disorientation, suicidal thoughts and actions
(Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure
• palpitations (Rare)
• nosebleed (Uncommon), swelling (inflammation) of the lungs
(Very rare)
• diarrhoea, nausea, vomiting (Common); dry mouth,
indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)

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 12/2016.


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Further information

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