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Active substance(s): MONTELUKAST SODIUM

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Montelukast Sodium 4 mg Oral Granules



Read all of this leaflet carefully before your child starts 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as your child’s.
• If your child gets any side effects, talk to your child’s 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 is and what it is used
2. What you need to know before
Montelukast is taken
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Contents of the pack and other


What Montelukast is and
what it is used for

Montelukast is a leukotriene receptor
antagonist that blocks substances called
leukotrienes. Leukotrienes cause narrowing
and swelling of airways in the lungs. By
blocking leukotrienes, Montelukast improves
asthma symptoms and helps control asthma.

Your doctor has prescribed Montelukast to
treat your child’s asthma, preventing asthma
symptoms during the day and night.
• Montelukast is used for the treatment of
6 months to 5 years old patients who are
not adequately controlled on their medication
and need additional therapy.
• Montelukast may also be used as an
alternative treatment to inhaled
corticosteroids for 2 to 5 year old patients
who have not recently taken oral
corticosteroids for their asthma and have
shown that they are unable to use inhaled
• Montelukast also helps prevent the
narrowing of airways triggered by exercise
for patients 2 years of age and older.
Your doctor will determine how Montelukast
should be used depending on the symptoms
and severity of your child's 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 you need to know before
Montelukast is taken

Tell your doctor about any medical problems
or allergies your child has now or has had.

Do not give Montelukast to your child:
• if he/she is allergic to montelukast or any of
the other ingredients of this medicine (listed
in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before
taking Montelukast:

• If your child’s asthma or breathing gets
worse, tell your doctor immediately.
• Oral Montelukast is not meant to treat acute
asthma attacks. If an attack occurs, follow
the instructions your doctor has given you
for your child. Always have your child’s
inhaled rescue medicine for asthma attacks
with you.
• It is important that your child take all
asthma medications prescribed by your
doctor. Montelukast should not be used
instead of other asthma medications your
doctor has prescribed for your child.
• If your child is on anti-asthma medicines, be
aware that if he/she develops a
combination of symptoms such as flu-like
illness, pins and needles or numbness of
arms or legs, worsening of pulmonary
symptoms, and/or rash, you should consult
your doctor.
• Your child should not take acetyl-salicylic
acid (aspirin) or anti-inflammatory
medicines (also known as non-steroidal
anti-inflammatory drugs or NSAIDs) if they
make his/her asthma worse.
Other medicines and Montelukast:
Some medicines may affect how Montelukast
works, or Montelukast may affect how your
child's other medicines work.
Tell your doctor or pharmacist if your child is
taking, has recently taken or might take any
other medicines.

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Tell your doctor if your child is taking the
following medicines before starting
• 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
Montelukast can be taken with or without

Pregnancy and breast-feeding:
This subsection is not applicable for
Montelukast Oral Granules since they are
intended for use in children 6 months to 5
years of age, however the following
information is relevant to the active ingredient,
Use in pregnancy
Women who are pregnant or intend to
become pregnant should consult their doctor
before taking Montelukast. Your doctor will
assess whether you can take Montelukast
during this time.
Use in breast-feeding
It is not known if Montelukast appears in
breast milk. You should consult your doctor
before taking Montelukast if you are
breast-feeding or intend to breast-feed.

Driving and using machines:
This subsection is not applicable for
Montelukast Oral Granules since they are
intended for use in children 6 months to 5
years of age, however the following
information is relevant to the active ingredient,
Montelukast 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 very rarely with Montelukast may
affect some patients’ ability to drive or operate


How to take Montelukast

• This medicine is to be given to a child under
adult supervision. Your child should take
Montelukast every evening.
• It should be taken even when your child has
no symptoms or if he/she has an acute
asthma attack.
• Always have your child take this medicine
exactly as your doctor has told you. Check
with your child’s doctor or pharmacist if you
are not sure.
• To be taken by mouth.
The usual dose is:

For children 6 months to 5 years of age:
One sachet of Montelukast 4 mg Oral
Granules to be taken by mouth each evening.
If your child is taking Montelukast, be sure
that your child does not take any other
products that contain the same active
ingredient, montelukast.
For children 6 months to 2 years old,
Montelukast granules are available.

For children 2 to 5 years old, Montelukast
4 mg chewable tablets and Montelukast
granules are available.

Montelukast granules are not recommended
for children below 6 months of age.

How should I give Montelukast to my child?
• Do not open the sachet until ready to use.
• Montelukast can be given either:
- directly in the mouth;
- OR mixed with a spoonful of cold or room
temperature soft food (for example,
applesauce, ice cream, carrots and rice).
• Mix all of the contents of Montelukast Oral
Granules into a spoonful of cold or room
temperature soft food, taking care to see
that the entire dose is mixed with the food.
• Be sure the child is given the entire
spoonful of the granule/food mixture
immediately (within 15 minutes).
IMPORTANT: Never store any granule/food
mixture for use at a later time.
• Montelukast Oral Granules are not intended
to be dissolved in liquid.
However, your child may take liquids after
swallowing Montelukast.
• Montelukast can be taken without regard to
the timing of food intake.
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If your child takes more Montelukast than
he/she should:
Contact your child’s doctor immediately for

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 give Montelukast to your
Try to give Montelukast as prescribed.
However, if your child misses a dose, just
resume the usual schedule of one sachet
once daily.

Do not give a double dose to make up for a
forgotten dose.

If your child stops taking Montelukast:
Montelukast can treat your child’s asthma only
if he/she continues taking it.
It is important for your child to continue taking
Montelukast for as long as your doctor
prescribes. It will help control your child’s
If you have any further questions on the use
of this medicine, ask your child’s doctor or


Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets

In clinical studies with montelukast 4 mg
granules, the most commonly reported side
effects (may affect up to 1 in 10 people)
thought to be related to montelukast 4 mg
granules were:
• diarrhoea
• hyperactivity
• asthma
• scaly and itchy skin
• rash.

Additionally, the following side effects were
reported in clinical studies with either
montelukast 10 mg film-coated tablets, 5 mg
or 4 mg chewable tablets:
• abdominal pain
• headache
• thirst.
These were usually mild and occurred at a
greater frequency in patients treated with
montelukast than placebo (a pill containing no
Additionally, while the medicine has been on
the market, the following have been reported:

Talk to a doctor straight away if you notice
any of the following serious side effects you may need urgent medical treatment:

Uncommon side effects (may affect up to 1 in
100 people):
• allergic reactions including rash, swelling of
the face, lips, tongue, and/or throat which
may cause difficulty in breathing or

Very rare side effects (may affect up to 1 in
10,000 people):
• suicidal thoughts and actions. Warning
signs are e.g. talking about suicide,
withdrawing from social contact and
wanting to be left alone or feeling trapped
or hopeless about a situation
• yellowing of the skin and eyes, unusual
tiredness or fever, dark coloured urine
caused by inflammation of the liver
• 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 your child gets
one or more of these symptoms
• severe skin reactions (erythema multiforme)
that may occur without warning.
Other possible side effects

Very common side effects (may affect more
than 1 in 10 people):
• upper respiratory infection.

Very rare side effects (may affect up to 1 in
10,000 people):
• hallucinations, disorientation
• swelling (inflammation) of the lungs
• tender red lumps under the skin most
commonly on your shins (erythema

Reporting of side effects
If your child gets any side effects, talk to your
child’s 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 medicine.


How to store Montelukast

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

Do not use this medicine after the expiry date
which is stated on the label carton and the
sachet 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.


Contents of the pack and other

What Montelukast Sodium 4 mg Oral
Granules contain
• The active substance is: montelukast.
Each sachet of granules contains
montelukast sodium which corresponds to
4 mg of montelukast.
• The other ingredients are: mannitol,
hydroxypropyl cellulose and magnesium
What Montelukast Sodium 4 mg Oral
Granules looks like and contents of the
Montelukast Oral Granules are white to off
white granules.
Montelukast Oral Granules are packed in
PET/ Al/ PE sachets.

Available in packs of 7, 10, 14, 20, 28, 30 and
100 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany or
Salutas Pharma GmbH,
Dieselstrasse 5 70839 Gerlingen,
Germany or

Lek Pharmaceuticals d.d.,
Verovškova, 571526 Ljubljana, Slovenia or
Lek S.A.,
Domaniewska 50 C, 02-672 Warszawa,
Poland or

S.C. Sandoz,
S.R.L.Livezeni, Street no 7A, Targu Mures,
Romania or
Lek Pharmaceuticals d.d.,
Trimlini 2D, 9220 Lendava, Slovenia or
ul. Podlipie 16, I 95-01 0 Strykow,

This leaflet was last revised in 01/2016.

Common side effects (may affect up to 1 in
10 people):
• diarrhoea, nausea, vomiting
• abnormal liver function test results
• rash
• fever.

Uncommon side effects (may affect up to 1 in
100 people):
• behaviour and mood related changes
(dream abnormalities, including nightmares,
trouble sleeping, sleep walking, irritability,
feeling anxious, restlessness, agitation
including aggressive behaviour or hostility,
• dizziness, drowsiness, pins and
needles/numbness, seizure
• nosebleed
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• tiredness, feeling unwell, swelling.

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Rare side effects (may affect up to 1 in 1,000
• increased bleeding tendency
• disturbance in attention
• memory impairment
• tremor
• palpitations


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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.