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Active substance(s): MONTELUKAST SODIUM

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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
- If you have any further questions, ask your
doctor or pharmacist.
- 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
1. What Montelukast 10 mg film-coated tablets
are and what they are used for
2. What you need to know before you take
Montelukast 10 mg film-coated tablets
3. How to take Montelukast 10 mg film-coated
4. Possible side effects
5. How to store Montelukast 10 mg film-coated
6. Contents of the pack and other information
1. What Montelukast 10 mg film-coated
tablets are and what they are used for
Montelukast is a leukotriene receptor
antagonist that blocks substances called
Leukotrienes cause narrowing and swelling of
airways in the lungs and also cause allergy
By blocking leukotrienes, this medicine
improves asthma symptoms, helps control
asthma and improves seasonal allergy
symptoms (also known as hay fever or
seasonal allergic rhinitis).
Your doctor has prescribed this medicine to
treat asthma, preventing your asthma
symptoms during the day and night.
 This medicine is used for the treatment of 15
years of age and older patients who are not
adequately controlled on their medication
and need additional therapy.
 This medicine also helps prevent the
narrowing of airways triggered by exercise.
 In those 15 years of age and older asthmatic
patients in whom this medicine is indicated in
asthma, this can also provide symptomatic
relief of seasonal allergic rhinitis.
Your doctor will determine how these 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
 sensitive airways that react to many things,
such as cigarette smoke, pollen, cold air, or
 swelling (inflammation) in the lining of the
Symptoms of asthma include: Coughing,
wheezing, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or
seasonal allergic rhinitis) are an allergic
response often caused by air borne pollens
from trees, grasses and weeds. The symptoms
of seasonal allergies typically may include:
stuffy, runny, itchy nose; sneezing; watery,
swollen, red, itchy eyes.

 are allergic to montelukast or any of the other
ingredients of this medicine (listed in section
Warnings and precautions
Talk to your doctor or pharmacist before taking
 If your asthma or breathing gets worse, tell
your doctor immediately.
 This oral medicine is not meant to treat acute
asthma attacks. If an attack occurs, follow
the instructions your doctor has given 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
 This medicine 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 aspirin (acetylsalicylic
acid) or anti-inflammatory medicines (also
known as non-steroidal anti-inflammatory
drugs or NSAIDs) if they make your asthma
Children and adolescents
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.
Other medicines and Montelukast 10 mg
film-coated tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
Some medicines may affect how Montelukast
works, or Montelukast may affect how other
medicines work.
Tell your doctor if you are taking the following
medicines before starting Montelukast:
 phenobarbital (used for treatment of
 phenytoin (used for treatment of epilepsy)
 rifampicin (used to treat tuberculosis and
some other infections)
 gemfibrozil (used for treatment of high lipid
levels in plasma)
Montelukast with food and drink
These tablets may be taken with or without
Pregnancy, breast-feeding and fertility
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 this medicine.

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 once a day as prescribed by
your doctor.
 It should be taken even when you have no
symptoms or have an acute asthma attack.
 To be taken by mouth
For adults 15 years of age and older:
One 10 mg tablet to be taken daily in the
evening. This tablet may be taken with or
without food.
If you are taking this medicine, be sure that you
do not take any other products that contain the
same active ingredient, montelukast.
If you take more Montelukast than you
Contact your doctor immediately for advice.
There were no side effects reported in the
majority of over dose 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
Try to take this medicine 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
This medicine can treat your asthma only if you
continue to take it.
It is important to continue taking this medicine
for as long as your doctor prescribes. It will help
control your asthma.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
Serious side effects
If you experience any of the following, stop
taking the medicine and tell your doctor
immediately or go to the casualty department of
your nearest hospital.
 Allergic reactions: If you have allergic
reactions, stop having this medicine and see
a doctor straight away. You may need urgent
medical treatment. The signs may include
rashes, swelling of the face, lips, tongue,
and/or throat which may cause difficulty in
breathing or swallowing.
 Behaviour and mood related changes:
Suicidal thoughts and actions.
 Churg-Strauss syndrome: Symptoms
include flu like illness, pins and needles or
numbness of arms and legs, worsening of
pulmonary symptoms and/or rash.
Other side effects

Use in pregnancy
Women who are pregnant or intend to become
pregnant should consult their doctor before
taking this medicine. Your doctor will assess
whether you can take this tablet during this
Use in breast-feeding
It is not known if this medicine appears in breast
milk. You should consult your doctor before
taking this tablet if you are breast-feeding or
intend to breast-feed.

In clinical studies with Montelukast 10 mg filmcoated tablets, the 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 this medicine were:
 abdominal pain
 headache
These were usually mild and occurred at a
greater frequency in patients treated with
Montelukast than placebo (a pill containing no

Driving and using machines
This medicine is 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 with
2. What you need to know before you take Montelukast may affect some patients' ability to
drive or operate machinery.
Montelukast 10 mg film-coated tablets

Very common: may affect more than 1 in 10
 upper respiratory infection
Common: may affect up to 1 in 10 people
 diarrhea, nausea, vomiting
 changes in liver function test
 rash
 fever

Tell your doctor about any medical problems or Montelukast 10 mg film-coated tablets
contain lactose
allergies you have now or have had.
If you have been told by your doctor that you
Do not take Montelukast if you
have an intolerance to some sugars, contact

Uncommon: may affect up to 1 in 100 people
 dream abnormalities, including nightmares,
trouble sleeping, sleep walking, irritability,
feeling anxious, restlessness, agitation

MARKET : UK, SIZE : 140X400MM,
SPIL-DWS : 20.08.16VS
OLD CODE : 5105626, ITF CODE : 05131559

including aggressive behaviour or hostility,
 dizziness, drowsiness, pins and
needles/numbness, seizure
 nose bleed
 dry mouth, indigestion
 bruising, itching, hives
 joint or muscle pain, muscle cramps
 tiredness, feeling unwell, swelling
Rare: may affect up to 1 in 1,000 people
 increased bleeding tendency
 tremor
 palpitations
Very rare: may affect up to 1 in 10,000 people
 hallucinations, disorientation
 hepatitis (inflammation of the liver)
 tender red lumps under the skin most
commonly on your shins (erythema
nodosum), severe skin reaction (erythema
multiforme) that may occur without warning
Reporting of side effects
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 at: By
reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Montelukast 10 mg film
coated tablets
Keep this medicine out of the sight and reach of
Do not use this medicine after the date which is
stated on the carton after EXP.The expiry date
refers to the last day of that month.
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
protect the environment.
6. Contents of the pack and other
What Montelukast 10-mg film-coated
tablets contains
The active substance is: montelukast. Each
tablet contains montelukast sodium which
corresponds to 10 mg of montelukast.
The other ingredients are: Microcrystalline
cellulose, lactose monohydrate,
croscarmellose sodium, hydroxypropyl
cellulose, magnesium stearate Film coating:
Opadry Yellow 03B 52874 (hypromellose,
titanium dioxide, macrogol, iron oxide yellow,
iron oxide red)
What Montelukast looks like and contents
ofthe pack
Montelukast 10 mg tablets are beige to light
yellow coloured, rounded square, film-coated
tablets, engraved with “M10” on one side and
plain on the other side.
Blisters in packages of: 14, 28, 30, 50, 56, 98
Not all pack sizes may be marketed
Marketing Authorisation Holder and
Marketing Authorisation Holder:
Ranbaxy UK Ltd
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom
Sun Pharmaceutical Industries Europe B.V.
Polaris avenue 87
2132 JH Hoofddorp
The Netherlands
Terapia SA
124 Fabricii Street
400 632 ClujNapoca
This leaflet was last revised in August 2016.

your doctor before taking this medicinal
3. How to take Montelukast 10 mg film
coated tablets

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