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SINGULAIR PAEDIATRIC 4MG CHEWABLE TABLETS

Active substance(s): MONTELUKAST / MONTELUKAST SODIUM

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XXXXXXX/XX-X

SINGULAIR® Paediatric 4 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 child’s.
• 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 SINGULAIR Paediatric is and what it is used for
2. Before SINGULAIR Paediatric is taken
3. How to take SINGULAIR Paediatric
4. Possible side effects
5. How to store SINGULAIR Paediatric
6. Further information
1. What SINGULAIR Paediatric is and what it is used for

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SINGULAIR Paediatric is a leukotriene receptor antagonist that blocks
substances called leukotrienes. Leukotrienes cause narrowing and
swelling of airways in the lungs. By blocking leukotrienes, SINGULAIR
Paediatric improves asthma symptoms and helps control asthma.
Your doctor has prescribed SINGULAIR Paediatric to treat your child’s
asthma, preventing asthma symptoms during the day and night.
• SINGULAIR Paediatric is used for the treatment of 2 to 5 year
old patients who are not adequately controlled on their
medication and need additional therapy.
• SINGULAIR Paediatric 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.
• SINGULAIR Paediatric also helps prevent the narrowing of airways
triggered by exercise for patients 2 years of age and older.
Your doctor will determine how SINGULAIR Paediatric 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 SINGULAIR Paediatric is taken
Tell your doctor about any medical problems or allergies your child
has now or has had.
Do not give SINGULAIR Paediatric to your child if he/she
• is allergic (hypersensitive) to montelukast or any of the other
ingredients of SINGULAIR Paediatric (see 6. Further information).
Take special care with SINGULAIR Paediatric
• If your child’s asthma or breathing gets worse, tell your doctor
immediately.
• Oral SINGULAIR Paediatric 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. SINGULAIR Paediatric 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.

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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.
Taking other medicines
Some medicines may affect how SINGULAIR Paediatric works, or
SINGULAIR Paediatric 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 SINGULAIR Paediatric:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Taking SINGULAIR Paediatric with food and drink
SINGULAIR Paediatric 4 mg chewable tablets should not be taken
immediately with food; they should be taken at least 1 hour before or
two hours after food.
Pregnancy and breast-feeding
This subsection is not applicable for the SINGULAIR Paediatric 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.
Use in pregnancy
Women who are pregnant or intend to become pregnant should
consult their doctor before taking SINGULAIR. Your doctor will assess
whether you can take SINGULAIR during this time.
Use in breast-feeding
It is not known if SINGULAIR appears in breast milk. You should consult
your doctor before taking SINGULAIR if you are breast-feeding or
intend to breast-feed.
Driving and using machines
This subsection is not applicable for the SINGULAIR Paediatric 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.
SINGULAIR 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 SINGULAIR may affect some
patients’ ability to drive or operate machinery.
Important information about some of the ingredients of
SINGULAIR Paediatric
SINGULAIR Paediatric chewable tablets contain aspartame, a source
of phenylalanine. If your child has phenylketonuria (a rare, hereditary
disorder of the metabolism) you should take into account that each
SINGULAIR Paediatric 4 mg chewable tablet contains phenylalanine
(equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
3. How to take SINGULAIR Paediatric


This medicine is to be given to a child under adult supervision.
For children who have problems consuming a chewable tablet,
an oral granule formulation is available.
• Your child should take only one tablet of SINGULAIR Paediatric
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 SINGULAIR Paediatric as your
doctor has told you. You should check with your child’s doctor or
pharmacist if you are not sure.
• To be taken by mouth
For children 2 to 5 years of age:
One SINGULAIR Paediatric 4 mg chewable tablet daily to be taken in
the evening. SINGULAIR Paediatric 4 mg chewable tablets 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 taking SINGULAIR Paediatric, be sure that he/she does
not take any other medicines that contain the same active ingredient,
montelukast.
For children 2 to 5 years old, SINGULAIR Paediatric 4 mg chewable
tablets and 4 mg granules are available.
For children 6 to 14 years old, SINGULAIR Paediatric 5 mg chewable
tablets are available. The SINGULAIR Paediatric 4 mg chewable tablet
is not recommended below 2 years of age.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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4. Possible side effects

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Like all medicines, SINGULAIR Paediatric can cause side effects,
although not everybody gets them.
In clinical studies with SINGULAIR Paediatric 4 mg chewable tablets,
the most commonly reported side effects (occurring in at least
1 of 100 patients and less than 1 of 10 paediatric patients treated)
thought to be related to SINGULAIR Paediatric were:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies
with SINGULAIR 10 mg film-coated tablets and 5 mg chewable
tablets:
• headache
These were usually mild and occurred at a greater frequency in
patients treated with SINGULAIR than placebo (a pill containing no
medication).
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)
• increased bleeding tendency (Rare)
• allergic reactions including swelling of the face, lips, tongue, and/
or throat which may cause difficulty in breathing or swallowing
(Uncommon)
• behaviour and mood related changes [dream abnormalities,
including nightmares, trouble sleeping, sleepwalking,
irritability, feeling anxious, restlessness, agitation including
aggressive behaviour or hostility, depression (Uncommon);
tremor, disturbance in attention, memory impairment (Rare);
hallucinations, disorientation, suicidal thoughts and actions
(Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure
(Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon), swelling (inflammation) of the lungs
(Very rare)
• 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), severe skin reactions (erythema multiforme) that may
occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); weakness/tiredness, feeling unwell, swelling
(Uncommon)
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.

Reporting of side effects
If your child gets any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly (see details below).
By reporting side effects you can help provide more information on
the safety of this medicine.
United Kingdom: Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
Malta: ADR Reporting, The Medicines Authority, Post-Licensing
Directorate, 203 Level 3, Rue D’Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt;
e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store SINGULAIR Paediatric






Keep out of the reach and sight of children.
Do not use this medicine after the date shown by the
six numbers following EXP on the blister. The first two numbers
indicate the month; the last four numbers indicate the year. This
medicine expires at the end of the month shown.
Store in the original package in order to protect from light and
moisture.
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
What SINGULAIR Paediatric contains
• The active substance is montelukast. Each tablet contains
montelukast sodium which corresponds to 4 mg of montelukast.
• The other ingredients are:
Mannitol, microcrystalline cellulose, hyprolose (E 463),
red ferric oxide (E 172), croscarmellose sodium, cherry flavour,
aspartame (E 951), and magnesium stearate.
What SINGULAIR Paediatric looks like and contents of the pack
SINGULAIR Paediatric 4 mg chewable tablets are pink, oval, biconvex
with SINGULAIR engraved on one side and MSD 711 on the other.
Blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and
200 tablets.
Blisters (unit doses) in packages of: 49, 50 and 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK.
SINGULAIR Paediatric 4 mg chewable tablets are manufactured by
Merck Sharp & Dohme BV, Waarderweg 39, PO Box 581, 2003 PC
Haarlem, The Netherlands.
Information is given by:
In UK: Asthma UK, Providence House, Providence Place,
London N1 ONT. Alternatively phone the Asthma UK Adviceline
on 08457 010203, Monday to Friday 9 am to 5 pm, calls charged at
local rate.
In Ireland: The Asthma Society of Ireland, Eden House,
15-17 Eden Quay, Dublin 1. Alternatively phone The Asthma Live
Line on 01 8788122, Monday, Wednesday, Thursday 10am to 1pm, or
01 8788511 9am to 5pm, or The Asthma Line on callsave 1850 44 5464.
(The Asthma UK and The Asthma Society of Ireland are independent
charities working to conquer asthma and are not associated with
Merck Sharp & Dohme Limited.)
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxemburg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovenia, Slovak Republic, Spain, Sweden,
United Kingdom
SINGULAIR
This leaflet was last revised in October 2014
© Merck Sharp & Dohme Limited 2014. All rights reserved.
PIL.SGA-4mg.13.UK.3912.II-081-WS-16

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If your child takes more SINGULAIR Paediatric than he/she should
Contact your child’s 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 SINGULAIR Paediatric to your child
Try to give SINGULAIR Paediatric 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 SINGULAIR Paediatric
SINGULAIR Paediatric can treat your child’s asthma only if he/she
continues taking it.
It is important for your child to continue taking SINGULAIR Paediatric
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 product, ask your
child’s doctor or pharmacist.

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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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