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MONTELUKAST 4MG GRANULES

Active substance(s): MONTELUKAST SODIUM

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12 August 2015

5
Version:

231-30-74660-C LEA MONTELUKAST GRANULES 4mg SAC TUK TEVA UK Ref:

MONTELUKAST 4 mg GRANULES • If your child is on anti-asthma medicines, be
For children from 6 months to 5 years aware that if he/she develops a combination
of symptoms such as flu-like illness, pins
of age
PACKAGE LEAFLET: INFORMATION FOR THE USER

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, 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 you get any of the side effects, talk to
your doctor or pharmacist. This includes
any possible side effects not listed in this
leaflet. See section 4.

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 granules
Some medicines may affect how Montelukast
granules work, or Montelukast granules may
affect how your child's 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
1. What Montelukast granules are and what Montelukast granules:
they are used for
• phenobarbital (used for treatment of epilepsy)
2. What you need to know before you take
• phenytoin (used for treatment of epilepsy)
Montelukast granules
• rifampicin (used to treat tuberculosis and
3. How to take Montelukast granules
some other infections)
4. Possible side effects
• gemfibrozil (used to treat
5. How to store Montelukast granules
hypertriglyceridaemia, mixed
6. Contents of the pack and other information hyperlipidaemia and primary
hypercholesterolaemia).
WHAT IS IN THIS LEAFLET:

1

WHAT MONTELUKAST GRANULES
Montelukast granules with food and drink
ARE AND WHAT THEY ARE USED FOR

Montelukast granules are a leukotriene
receptor antagonist that blocks substances
called leukotrienes. Leukotrienes cause
narrowing and swelling of airways in your
lungs. By blocking leukotrienes, Montelukast
granules improve asthma symptoms and help
control asthma.

Montelukast granules can be taken without
regard to the timing of food intake.
Pregnancy and breast-feeding
This subsection is not applicable for
Montelukast 4 mg 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.

Your doctor has prescribed Montelukast
granules to treat your child’s asthma, preventing Use in pregnancy
asthma symptoms during the day and night. Women who are pregnant or intend to
become pregnant should consult their doctor
• Montelukast granules are used for the
before taking montelukast. Your doctor will
treatment of 6 months to 5 year old patients
assess whether you can take montelukast
who are not adequately controlled on their
during this time.
medication and need additional therapy
• Montelukast granules may also be used as Use in breast-feeding
It is not known if montelukast appears in
an alternative treatment to inhaled
corticosteroids for 2 to 5 year old patients breast milk. You should consult your doctor
before taking montelukast if you are
who have not recently taken oral
breast-feeding or intend to breast-feed.
corticosteroids for their asthma and have
shown that they are unable to use inhaled Driving and using machines
corticosteroids
This subsection is not applicable for
• Montelukast granules also help prevent the Montelukast 4 mg granules since they are
narrowing of airways triggered by exercise intended for use in children 6 months to
for patients 2 years of age and older.
5 years of age, however the following

Your doctor will determine how Montelukast information is relevant to the active
ingredient, montelukast.
granules should be used depending on the
symptoms and severity of your child's asthma. Montelukast has minor influence on the ability
to drive and use machines. However,
What is asthma?
individual responses to medication may vary.
Asthma is a long-term disease.
Certain side effects (such as dizziness and
Asthma includes:
drowsiness) that have been reported very
• difficulty breathing because of narrowed
rarely with montelukast may affect some
airways. This narrowing of airways worsens patients’ ability to drive or operate machinery.
and improves in response to various
conditions.
TO TAKE MONTELUKAST
3 HOW
• sensitive airways that react to many things,
GRANULES
such as cigarette smoke, pollen, cold air, or
exercise
• This medicine is to be given to a child under
• swelling (inflammation) in the lining of the
adult supervision. Your child should take
airways .
Montelukast granules every evening.
Symptoms of asthma include: Coughing,
• It should be taken even when your child has
wheezing, and chest tightness.
no symptoms or if he/she has an acute
asthma attack
WHAT
YOU
NEED
TO
KNOW
BEFORE

Always have your child take Montelukast
2 YOU TAKE MONTELUKAST GRANULES granules
as your doctor has told you. You
should check with your child’s doctor or
Do not use Montelukast granules
pharmacist if you are not sure.
If your child is allergic (hypersensitive) to
• To be taken by mouth.
montelukast sodium or any of the other
For children 6 months to 5 years of age:
ingredients of this medicine (listed in section 6).
One sachet of Montelukast 4 mg granules to
Warnings and precautions
be taken by mouth each evening.
• If your child’s asthma or breathing gets
If your child is taking Montelukast granules, be
worse, tell your doctor immediately
sure that your child does not take any other
• Oral Montelukast granules are not meant to
products that contain the same active
treat acute asthma attacks. If an attack
ingredient, montelukast.
occurs, follow the instructions your doctor
has given you for your child. Always have For children 6 months to 2 years old,
Montelukast 4 mg granules are available.
your child’s inhaled rescue medicine for
For children 2 to 5 years old, Montelukast
asthma attacks with you.
• It is important that your child take all asthma 4 mg chewable tablets and Montelukast 4 mg
granules are available. The Montelukast 4 mg
medications prescribed by your doctor.
Montelukast granules should not be used granules formulation is not recommended
instead of other asthma medications your below 6 months of age.
doctor has prescribed for your child.

12 August 2015

5
Version:

231-30-74660-C LEA MONTELUKAST GRANULES 4mg SAC TUK TEVA UK Ref:

How should I give Montelukast 4 mg Granules • allergic reactions including rash, swelling of
the face, lips, tongue, and/or throat which
to my child?
may cause difficulty in breathing or
• Do not open the sachet until ready to use
swallowing (Uncommon)
• Montelukast granules can be given either:
• behaviour and mood related changes
• directly in the mouth
[dream abnormalities, including nightmares,
• OR mixed with a spoonful of cold or room
trouble sleeping, sleep walking, irritability,
temperature soft food (for example, apple
feeling anxious, restlessness, agitation
sauce, ice cream, carrots and rice)
including aggressive behaviour or hostility,
• Mix all of the contents of the Montelukast
depression (Uncommon); tremor (Rare);
granules into a spoonful of cold or room
hallucinations, disorientation, suicidal
temperature soft food, taking care to see
thoughts and actions (Very rare)]
that the entire dose is mixed with the food
• dizziness, drowsiness, pins and
• Be sure the child is given the entire spoonful
needles/numbness, seizure (Uncommon)
of the granule/food mixture immediately
• palpitations (Rare)
(within 15 minutes). IMPORTANT: Never
• nosebleed (Uncommon)
store any granule/food mixture for use at a
• diarrhoea, nausea, vomiting (Common); dry
later time.
mouth, indigestion (Uncommon)
• Montelukast granules are not intended to be
• hepatitis (inflammation of the liver) (Very
dissolved in liquid. However, your child may
rare)
take liquids after swallowing the Montelukast
• bruising, itching, hives (Uncommon); tender
granules.
red lumps under the skin most commonly on
• Montelukast granules can be taken without
your shins (erythema nodosum), severe skin
regard to the timing of food intake.
reactions (erythema multiforme) (Very rare)
If your child takes more Montelukast Granules • joint or muscle pain, muscle cramps
than he/she should
(Uncommon)
Contact your child’s doctor immediately for • fever (Common); tiredness, feeling unwell,
advice.
swelling (Uncommon).
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.

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 you forget to give Montelukast granules to
if
your
child
gets one or more of these
your child
symptoms.
Try to give Montelukast granules 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
granules
Montelukast granules can treat your child’s
asthma only if he/she continues taking it.
It is important for your child to continue taking
Montelukast granules for as long as your
doctor prescribes. It will help control your
child’s asthma.

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

5

HOW TO STORE MONTELUKAST
GRANULES

If you have any further questions on the use of Keep this medicine out of the sight and reach
of children.
this product, ask your child’s doctor or
pharmacist.
Do not use this medicine after the date shown
on the sachet after EXP. The first two numbers
indicate the month; the last four numbers
4 POSSIBLE SIDE EFFECTS
indicate the year. This medicine expires at the
Like all medicines, this medicine can cause
end of the month shown.
side effects, although not everybody gets them.
Store in the original package in order to
The following terms are used to describe how protect from light and moisture.
often side effects have been reported:
Do not throw away any medicines via waste
very common: affects more than 1 user in 10 water or household waste. Ask your
pharmacist how to throw away medicines
common:
affects 1 to 10 users in 100
you no longer use. These measures will help
uncommon:
affects 1 to 10 users in 1,000
protect the environment.
rare:
affects 1 to 10 users in 10,000
CONTENTS OF THE PACK AND OTHER
very rare:
affects less than 1 user in
6 INFORMATION
10,000
not known:
frequency cannot be estimated What Montelukast granules contain
from the available data
• The active substance is montelukast. Each
sachet of granules contains montelukast
In clinical studies with montelukast 4 mg
sodium which corresponds to 4 mg
granules, the most commonly reported side
montelukast.
effects (occurring in at least 1 of 100 patients • The other ingredients are mannitol,
and less than 1 of 10 paediatric patients
hydroxypropyl cellulose, sodium
treated) thought to be related to montelukast
laurilsulfate and magnesium stearate.
were:
What Montelukast granules look like and
• diarrhoea
contents of the pack
• hyperactivity
Montelukast 4 mg Granules are white to
• asthma
off-white granules.
• scaly and itchy skin
Cartons of 7, 20, 28, 30 and 98 sachets.
• rash.
Not all pack sizes may be marketed.
Additionally, the following side effects were
Marketing Authorisation Holder
reported in clinical studies with either
TEVA UK Limited, Eastbourne, BN22 9AG, UK.
montelukast 10 mg Film-coated Tablets or
montelukast 5 mg or 4 mg chewable tablets: Manufacturer
• abdominal pain
Teva Operations Poland Sp. z o.o.
• headache
ul. Mogilska 80, 31546 Kraków, Poland.
• thirst.
This leaflet was last revised in January 2015.
These were usually mild and occurred at a
PL 00289/1702
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:
• upper respiratory infection (Very common)
• increased bleeding tendency (Rare)
74660-C

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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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