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SINGULAIR PAEDIATRIC 4MG CHEWABLE TABLETS

Active substance(s): MONTELUKAST / MONTELUKAST SODIUM / MONTELUKAST / MONTELUKAST SODIUM / MONTELUKAST / MONTELUKAST SODIUM

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Package leaflet: Information for the user

Singulair® Paediatric 4 mg
chewable tablets

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montelukast
Read all of this leaflet carefully before you give this medicine to
your child because it contains important information.
• 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. See section 4.
What is in this leaflet
1. What Singulair Paediatric is and what it is used for
2. What you need to know before your child takes Singulair
Paediatric
3. How to take Singulair Paediatric
4. Possible side effects
5. How to store Singulair Paediatric
6. Contents of the pack and other information
1. What Singulair Paediatric is and what it is used for
What Singulair Paediatric is
Singulair Paediatric is a leukotriene receptor antagonist that blocks
substances called leukotrienes.
How Singulair Paediatric works
Leukotrienes cause narrowing and swelling of airways in the lungs.
By blocking leukotrienes, Singulair Paediatric improves asthma
symptoms and helps control asthma.
When Singulair Paediatric should be used
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. What you need to know before your child takes Singulair
Paediatric
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 to montelukast or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before you give Singulair Paediatric
to your child.
• 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.
• 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.
Children and adolescents
Do not give this medicine to children less than 2 years of age.
There are different form(s) of this medicine available for paediatric
patients under 18 years of age based on age range.
Other medicines and Singulair Paediatric
Tell your doctor or pharmacist if your child is taking or has recently
been given or might be given any other medicines including those
obtained without a prescription.
Some medicines may affect how Singulair Paediatric works, or
Singulair Paediatric may affect how your child’s other medicines work.
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)
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 2 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.
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 Paediatric 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 with Singulair Paediatric may affect some
patients’ ability to drive or operate machinery.
Singulair Paediatric 4 mg 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 4 mg chewable
tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine
per 4 mg chewable tablet).
3. How to take Singulair Paediatric
Always have your child take this medicine exactly as your doctor
or pharmacist has told you. Check with your child’s doctor or
pharmacist if you are not sure.
• 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 chewable 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.
For children 2 to 5 years of age:
The recommended dose is one 4 mg chewable tablet daily to be
taken in the evening.
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.
This medicine is for oral use.
The tablets are to be chewed before swallowing.
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.
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.

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Technical Info

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Profile Revision:
Profile Revision Date:
Dimensions (mm):

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148 x 260

4. Possible side effects
Like all medicines, this medicine 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: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
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 (See section 2).
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 at: www.medicinesauthority.gov.mt/adrportal
5. How to store Singulair Paediatric
• 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 after EXP. The first two numbers indicate the month;
the last four numbers indicate the year. The expiry date refers to
the last date of that month.
• Store in the original package in order to protect from light and
moisture.
• 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 Singulair Paediatric contains
• The active substance is montelukast. Each chewable tablet
contains montelukast sodium which corresponds to 4 mg of
montelukast.
• The other ingredients are:
Mannitol (E 421), 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
4 mg Singulair Paediatric 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 dose), in packages of: 49x1, 50x1 and 56x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder:
United Kingdom/Malta: Merck Sharp & Dohme Ltd, Hertford Road,
Hoddesdon, Hertfordshire EN11 9BU, UK.
Ireland: Merck Sharp & Dohme Ireland (Human Health) Ltd, Red
Oak North, South County Business Park, Leopardstown, Dublin 18,
Ireland.
The manufacturer:
Merck Sharp & Dohme BV, Waarderweg 39, PO Box 581, 2003 PC
Haarlem, The Netherlands.
Information is given by:
In UK: Asthma UK, 18 Mansell Street, London E1 8AA. Alternatively
phone the Asthma UK Helpline on 0300 222 5800, Monday to Friday
9 am to 5 pm, calls charged at local rate.
In Ireland: The Asthma Society of Ireland, 42 - 43 Amiens Street,
Dublin 1, tel: 01 817 8886. Alternatively call the Asthma Adviceline
on 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, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovenia, Slovak Republic, Spain, Sweden, United Kingdom
Singulair
This package leaflet was last revised in June 2016
© Merck Sharp & Dohme Limited 2016. All rights reserved.
PIL.SGA.4mg.13.UK.3870.IB-078-WS-14

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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 chewable 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 medicine, ask
your child’s doctor or pharmacist.

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.

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