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MONTELUKAST SANDOZ 5MG CHEWABLE TABLETS

Active substance(s): MONTELUKAST SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Montelukast 5 mg Chewable Tablets

montelukast

Read all of this leaflet carefully before your child starts taking this
medicine.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as your
childʼs.
• 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 pharmacist.

In this leaflet:
1. What Montelukast is and what it is
used for
2. Before Montelukast is taken
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Further 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 childʼs
asthma, preventing asthma
symptoms during the day and night.

• Montelukast 5 mg is used for the
treatment of 6 to 14 year old
patients who are not adequately
controlled on their medication and
need additional therapy.
• Montelukast 5 mg may also be
used as an alternative treatment to
inhaled corticosteroids for 6 to
14 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 5 mg also helps
prevent the narrowing of airways
triggered by exercise.
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, cold air, or exercise.
• swelling (inflammation) in the lining
of the airways.
Symptoms of asthma include:
Coughing, wheezing, and chest
tightness.

2

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 (hypersensitive) to
montelukast or any of the other
ingredients of Montelukast 5 mg
chewable tablets (see 6. Further
information).

Take special care with Montelukast
• If your childʼs 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 childʼs inhaled rescue
medicine for asthma attacks with
you.
• It is important that your child takes
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 aspirin
(acetyl-salicylic acid) or
anti-inflammatory medicines (also
known as non-steroidal
anti-inflammatory drugs or NSAIDs)
if they make his/her asthma worse.

Taking other medicines
Some medicines may affect how
Montelukast works, or Montelukast
may affect how your childʼs other
medicines work.

Please tell your doctor or pharmacist
if your child is taking or has recently
taken other medicines, including
those obtained without a prescription.

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).
Taking Montelukast with food and
drink
Montelukast 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
Montelukast 5 mg chewable tablets
since they are intended for use in
children 6 to 14 years of age,
however the following information is
relevant to the active ingredient,
montelukast.

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
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
patientsʼ ability to drive or operate
machinery.

Important information about some
of the ingredients of Montelukast
Montelukast chewable tablets contain
aspartame, which contains a source
of phenylalanine. This may be
harmful for people with
phenylketonuria (a rare, hereditary
disorder of the metabolism).
Montelukast 5 mg chewable tablets
contain phenylalanine (equivalent to
0.674 mg phenylalanine per 5 mg
chewable tablet).

Montelukast 5 mg chewable tablets
contain Allura Red (E129). This may
cause allergic reactions.

3

How to take Montelukast

• 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
Montelukast as your doctor has told
you. You should check with your
childʼs doctor or pharmacist if you
are not sure.
• To be taken by mouth.
For children 6 to 14 years of age:
One 5 mg chewable tablet daily to be
taken in the evening. Montelukast
should not be taken immediately with
food; it should be taken at least 1
hour before or 2 hours after food.
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If your child is taking Montelukast, be
sure that he/she does not take any
other medicines that contain the
same active ingredient, montelukast.
Montelukast 5 mg Chewable Tablets
are not recommended for children
below 6 years of age.

Different strengths and dosage forms
may be available for the other age
groups:
• 4 mg chewable tablets are available
for children 2 to 5 years of age.
• 10 mg tablets are available for
adults and adolescents 15 years of
age and older.
If your child takes more
Montelukast than he/she should
Contact your childʼs 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 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 childʼs
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 childʼs asthma.
If you have any further questions on
the use of this product, ask your
childʼs doctor or pharmacist.

4

Possible side effects

Like all medicines, Montelukast can
cause side effects, although not
everybody gets them.

Serious side effects
If you develop any of the following
side effects, contact your doctor
immediately:
• 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
• allergic reactions including rash,
swelling of the face, lips, tongue,
and/or throat which may cause
difficulty in breathing or swallowing
• behaviour and mood related
changes (dream abnormalities,
including nightmares, trouble
sleeping, sleep walking, irritability,
feeling anxious, restlessness,
agitation including aggressive
behaviour or hostility, depression).
The following side effect was
reported in clinical studies with 5 mg
chewable tablets:
• headache.
These were usually mild and
occurred at a greater frequency in
patients treated with montelukast
than placebo (a pill containing no
medication).

Additionally, while the medicine has
been on the market, the following
have been reported:
• increased bleeding tendency
• allergic reactions including rash,
swelling of the face, lips, tongue,
and/or throat which may cause
difficulty in breathing or swallowing
• behaviour and mood related
changes [dream abnormalities
including nightmares,
hallucinations, irritability, feeling
anxious, restlessness, agitation
including aggressive behaviour,
tremor, depression, trouble
sleeping, suicidal thoughts and
actions (in very rare cases)]
• dizziness, drowsiness, pins and
needles/numbness, seizure
• palpitations
• nosebleed
• diarrhoea, dry mouth, indigestion,
nausea, vomiting
• hepatitis
• bruising, itching, hives, tender red
lumps under the skin most
commonly on your shins (erythema
nodosum)
• joint or muscle pain, muscle cramps
• tiredness, feeling unwell, swelling,
fever.

In asthmatic patients treated with
montelukast, very rare cases (affects
less than 1 user in 10,000) 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.

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
childʼs doctor or pharmacist.

5

How to store Montelukast

Keep out of the reach and sight of
children.

Do not use this medicine after the
expiry date which is stated on the
carton. The expiry date refers to the
last day of that month.

Store in the original package in order
to protect from moisture and light.
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.

6

Further information

• The active substance is
montelukast.
Each tablet contains 5 mg of
montelukast as montelukast
sodium.
• The other ingredients are:
Mannitol (E421), cellulose
microcrystalline,
hydroxypropylcellulose (E463), iron
oxide, red (E172), croscarmellose
sodium, flavour (Cherry Flavour
AP0551, Cherry Duarome
TD0990B [contains Allura Red,
E129]), aspartame (E951) and
magnesium stearate.
What Montelukast looks like and
contents of the pack
5 mg Montelukast chewable tablets
are pink to slightly speckled pink,
round with ʻ5ʼ encoded on one side.

Montelukast is available in packs of:
7, 10, 14, 15, 20, 28, 30, 49, 50, 56,
60, 84, 90, 98, 100, 140, 200
chewable tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR
United Kingdom
Manufacturer
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 57, 1526 Ljubljana,
Slovenia
or

Lek Pharmaceuticals d.d., Trimlini 2
D, 9220 Lendava, Slovenia
or

LEK S.A., Ul. Podlipie 16 C, 95 010
Strykow, Poland
or

LEK S.A., Ul. Domaniewska 50,
02-672 Warszawa, Poland
or

S.C. Sandoz S.R.L., Str. Livezeni nr.
7A, 540472 Targu-Mures, Romania
This leaflet was last revised in
03/2015.

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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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