Skip to Content

UK Edition. Click here for US version.

MONTELUKAST SANDOZ 4MG CHEWABLE TABLETS

Active substance(s): MONTELUKAST SODIUM / MONTELUKAST SODIUM

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Montelukast 4 mg Chewable Tablets

Montelukast

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 for
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
information

1

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)
• gemfibrozil (used for treatment of high
lipid levels in plasma)

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.

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.

Your doctor has prescribed Montelukast
to treat your child’s asthma, preventing
asthma symptoms during the day and
night.

Pregnancy and breast-feeding
This subsection is not applicable for
Montelukast 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 4 mg is 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 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 also helps prevent
the narrowing of airways triggered by
exercise for patients 2 years of age and
older.

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.

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.

Driving and using machines
This subsection is not applicable for
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.

Symptoms of asthma include: Coughing,
wheezing, and chest tightness.

2

What you need to know
before Montelukast is taken

Montelukast contains aspartame,
which contains a source of phenylalanine.
This may be harmful for people with
phenylketonuria (a rare, hereditary
disorder of the metabolism).

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

Montelukast 4 mg chewable tablets
contains Allura Red (E129). This may
cause allergic reactions.

Do not give Montelukast to your child
if he/she
• is allergic (hypersensitive) to
montelukast or any of the other
ingredients of this medicine (listed in
section 6)

3

Warnings and precautions
Talk to your doctor or pharmacist before
taking Montelukast:

How to take Montelukast

• This medicine is to be given to a child
under adult 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
Montelukast as your doctor has told
you. Check with your child’s doctor or
pharmacist if you are not sure.
• To be taken by mouth

• 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.

The recommended dose is:

• 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.

For children 2 to 5 years of age:
One 4 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. The tablets are to be
chewed before swallowing.

• 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.

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 is not recommended below
2 years of age.

• 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.

• For children 2 to 5 years old, 4 mg
chewable tablets and 4 mg granules
are available (for children who have
problems consuming a chewable tablet).
• For children 6 to 14 years old, 5 mg
chewable tablets are available.

Other medicines and Montelukast
Some medicines may affect how
Montelukast works, or Montelukast may
affect how your child’s other medicines
work.

If your child takes more Montelukast
than he/she should
Contact your child’s doctor immediately
for advice.

Tell your doctor or pharmacist if your child
is taking, has recently taken or might take
any other medicines, including those
obtained without a prescription.

Continued on the next page >>

00000000

draft: 44040121
laetus code: 0000
mat.no.: 00000000

Artwork Proof Box
Ref: V023: SPC & PIL update to be in line with originator + RFI
Proof no.
003.1

Date prepared:
27/10/2016

Colours:
Black
Dimensions: 148 x 630 mm

Font size:
9.5pt
Fonts:
Helvetica

5

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.

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

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 use this medicine after the expiry
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 give a double dose to make up for
a forgotten dose.

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.

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.

6

If you have any further questions on the
use of this medicine, ask your child’s
doctor or pharmacist.

4

How to store Montelukast

Contents of the pack and
other information

• The active substance is montelukast.

Each tablet contains 4 mg of montelukast
as montelukast sodium.

Possible side effects

• The other ingredients are:
Mannitol (E421), cellulose
microcrystalline, hydroxypropylcellulose
(E463), iron oxide, red (E172),
croscarmellose sodium, flavour (Cherry
Flavour AP0551, Cherry Durarome
TD0990B [contains Allura Red, E129]),
aspartame (E951) and magnesium
stearate.

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

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

What Montelukast looks like and
contents of the pack

Uncommon (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 swallowing

Montelukast are pink to slightly speckled
pink, oval tablets with ‘4’ 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

Rare: may affect up to 1 in 1,000 people
• increased bleeding tendency (also
unexplained bruising or bleeding
should be reported)

Not all pack sizes may be marketed.

Very rare (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
(hepatitis)
• 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

Marketing Authorisation Holder

Sandoz Ltd.,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

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

Other side effects

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

Following side effects were reported in
clinical studies with either 10 mg film
coated tablets and 5 mg or 4 mg
chewable tablets:
• abdominal pain
• headache
• thirst

S.C. Sandoz S.R.L., Str. Livezeni nr. 7A,
540472 Targu-Mures, Romania.

This leaflet was last revised in
10/2016.

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:

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

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

Uncommon (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,
depression)
• dizziness, drowsiness, pins and
needles/numbness, seizure
• nosebleed
• 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):
• tremor
• disturbance in attention, memory
impairment
• palpitations

Very rare (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
nodosum)

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:
www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the safety of
this medicine.

00000000
SZ00000LT000

draft: 44040121
laetus code: 0000
mat.no.: 00000000

Artwork Proof Box
Ref: V023: SPC & PIL update to be in line with originator + RFI
Proof no.
003.1

Date prepared:
27/10/2016

Colours:
Black
Dimensions: 148 x 630 mm

Font size:
9.5pt
Fonts:
Helvetica

Expand Transcript

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.

Hide