MONTELUKAST 4MG CHEWABLE TABLETS

Active substance: MONTELUKAST SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER



Montelukast 4 mg chewable tablets
For children from 2 to 5 years
Read all of this leaflet carefully before you start giving this medicine to your child 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 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 doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.

What is in this leaflet
1. What Montelukast is and what it is used for
2. What you need to know before you give
Montelukast to your child
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Contents of the pack and other information

1. 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 4 mg chewable tablets are used for the
treatment of 2 to 5 year old patients who are not
adequately controlled on their medication and need
additional therapy.
Montelukast 4 mg chewable tablets 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 corticosteroids.
Montelukast 4 mg chewable tablets also help
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 conditions.
• sensitive airways that react to many things, such
as cigarette smoke, pollen, or cold air, or exercise.
• swelling (inflammation) in the lining of airways.
Symptoms of asthma include: Coughing, wheezing,
and chest tightness.

2. What you need to know before
you give Montelukast to your
child
Tell your doctor about any medical problems or
allergies your child has now or has had.
Do not give Montelukast to your child:
• if your child is allergic to montelukast or any of

the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
• 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. Always
have your child’s inhaled rescue medicine for
asthma attacks with you.

• It is important that your child uses all the asthma

medication prescribed by the doctor. Montelukast
4 mg chewable tablets should not be used instead
of other asthma medications your doctor has
prescribed to 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.
Tell your doctor if your child is taking the following
medicines before starting Montelukast
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some
other infections).
Montelukast with food
Montelukast 4 mg chewable tablets should not be
taken immediately with food; they should be taken
at least 1 hour before or 2 hours after food
Pregnancy and breast-feeding
This subsection is not applicable for the Montelukast
4 mg chewable tablets since they are intended for
use in children 2 to 5 years of age, however the
following information is relevant to the active
ingredient, montelukast.
Pregnancy
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. Your doctor will assess whether you can
take Montelukast during this time.
Breast-feeding
It is not known whether 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 the Montelukast
4 mg chewable tablets since they are intended for
use in children 2 to 5 years of age, however the
following information is relevant to the active
ingredient, montelukast.
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
machinery.
Montelukast contains aspartame
Contains a source of phenylalanine. May be harmful
for children with phenylketonuria.

3. How to take Montelukast

• increased bleeding tendency (rare)
• allergic reactions including swelling of the face, lips,

• This medicine is to be given to a child under adult

tongue, and/or throat which may cause difficulty in
breathing or swallowing (uncommon)
• behaviour and mood related changes [dream
abnormalities, including nightmares, trouble
sleeping, sleep walking, irritability, feeling anxious,
restlessness, agitation including aggressive
behaviour or hostility, depression (Uncommon);
tremor (Rare); hallucination, disorientation, suicidal
thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness,
seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth,
indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• rash (Common); bruising, itching, hives
(Uncommon); tender red lumps under the skin most
commonly on your shins (erythema nodosum) (Very
rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); tiredness, feeling unwell, swelling
(Uncommon).



supervision.
• Your child should take only one tablet of
Montelukast once a day as prescribed by your
doctor.
• 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 or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
• To be taken by mouth
Use in children 2 to 5 years of age:
One 4 mg chewable tablet daily to be taken in the
evening. Montelukast 4 mg chewable tablets should
not be taken immediately with food; they should be
taken at least 1 hour before or 2 hours after food.
If your child is taking Montelukast, be sure that he/she
does not take any other medicine that contains the
same active ingredient, montelukast.
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.
The Montelukast 4 mg chewable tablets are not
recommended below 2 years of age.
If your child takes more Montelukast than he/
she should
Contact your doctor immediately for advice.

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 your child gets
one or more of these symptoms.

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 your child gets any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

If you forget to give Montelukast to your child
Try to give Montelukast as prescribed. However, if your
child misses a dose, just resume the usual schedule
of one tablet 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 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.
In clinical studies with montelukast 4 mg chewable
tablets, the most commonly reported side effect
(occurring in at least 1 of 100 patients and less than
1 of 10 paediatric patients treated) thought to be
related to treatment with montelukast were:
• Abdominal pain
• Thirst.
In clinical studies with montelukast 5 mg chewable
tablets, the most commonly reported side effect
(occurring in at least 1 of 100 patients and less than
1 of 10 paediatric patients treated) thought to be
related to montelukast was:
• Headache
Additionally, the following side effect was reported in
clinical studies with montelukast 10 mg film coated
tablets:
• Abdominal pain
These were usually mild and occurred with the same
frequency in patients treated with montelukast or
placebo (tablets that do not contain any active
substance).
The frequency of possible side effects listed below is
defined using the following convention:
Very common (affects at least 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 in 10,000)
Very rare (affects less than 1 user in 10,000)
Additionally, while the medicine has been on the
market, the following have been reported:
• upper respiratory infection (very common)

5. 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 blister and 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.
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
information

What Montelukast chewable tablets contain

• The active substance is montelukast.
Each chewable tablet contains 4 mg montelukast
(as montelukast sodium).
• The other ingredients are mannitol (E421),
microcrystalline cellulose, croscarmellose sodium,
hydroxypropylcellulose, aspartame (E951), red iron
oxide (E172), flavour cherry black (also contains
glyceryl triacetate (E1518)) and magnesium
stearate (see section 2).

What Montelukast chewable tablets look like
and contents of the pack
Pink, marbled, round, slightly biconvex tablets with
bevelled edges and inscription 4 on one side.
Boxes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90,
98, 100, 140 or 200 chewable tablets in blisters are
available.
Marketing Authorisation Holder
Krka d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo
mesto, Slovenia
Manufacturer(s)
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501
Novo mesto, Slovenia
KRKA Polska Sp. z o.o., ul. Równoległa 5, 02-235
Warsaw, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5,
27472 Cuxhaven, Germany
Distributed by:
Consilient Health (UK) Ltd., 500 Chiswick High Road,
London, W4 5RG.
This leaflet was last revised 04/2013
P0189

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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.

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