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MONTELUKAST PAEDIATRIC 4MG CHEWABLE TABLETS

Active substance(s): MONTELUKAST / MONTELUKAST SODIUM

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T05603

SINGULAIR® PAEDIATRIC 4 mg chewable tablets

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

Patient Information Leaflet

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)

(montelukast sodium)

This medicine is available in the above name but will be referred to as SINGULAIR Paediatric
throughout the:
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
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.
• 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.

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.
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.

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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.
4.

Possible side effects

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)

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.
Singulair Paediatric is available in blisters packages of 28 tablets.
Manufacturer and Product Licence Holder
Singulair Paediatric is manufactured by Merck Sharp & Dohme BV, Waarderweg 39, PO Box 581,
2003 PC Haarlem, The Netherlands. It is procured from within the EU by the Product Licence
Holder: Swinghope Ltd, Brandon House, Marlowe Way, Croydon CR0 4XS UK. Repackaged by
Interport Ltd, Brandon House, Marlowe Way, Croydon CR0 4XS UK.
POM

PLPI 10380/1413

Leaflet revision date: 09/03/2015.
Singulair® is a registered trademark of Merck & Co., Inc., USA.
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.)

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 you get 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 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 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.
• Do not store above 30°C.
• 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.

T05603

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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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