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MONTELUKAST PAEDIATRIC 4MG CHEWABLE TABLETS

Active substance(s): MONTELUKAST / MONTELUKAST SODIUM

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SINGULAIR® PAEDIATRIC 4 mg chewable tablets
(montelukast sodium)

Package leaflet: Information for the user
The name of your medicine is SINGULAIR PAEDIATRIC 4 mg chewable tablets but it will be referred to
as Singulair Paediatric throughout the remainder of this leaflet.
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.
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.
continued overleaf

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)

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, Commerce Way, Edenbridge, TN8 6ED, UK and repackaged by YMD Pharma Ltd,
Commerce Way, Edenbridge, TN8 6ED, UK.
POM

PL No: 10380/1413

Singulair Paediatric 4 mg chewable tablets

Leaflet revision date: 02/11/2017
Singulair® is a registered trademark of Merck & Co., Inc., USA.
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, Swinghope Limited or YMD
Pharma Limited.)

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 02030969700 to obtain the leaflet in a
format suitable for you.

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 via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App
Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 store above 30°C.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the
advice of your doctor or pharmacist who will tell you what to do.
• 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, microcrystalline cellulose, hyprolose (E463), red ferric oxide
(E172), croscarmellose sodium, cherry flavour, aspartame (E951) 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 blister packages of 28 tablets.
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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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