SINGULAIR PAEDIATRIC 4 MG GRANULES

Active substance: MONTELUKAST

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SINGULAIR® Paediatric 4 mg Granules
(montelukast sodium)
Read all off 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.
 Your medicine will be referred to as Singulair Paediatric throughout the
remainder of this leaflet.
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 6 months 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 antiinflammatory medicines (also known as non-steroidal antiinflammatory 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 granules can be taken without regard to the timing of
food intake.
Pregnancy and breast-feeding
This subsection is not applicable for the Singulair Paediatric 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.
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
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.
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.
3) HOW TO TAKE SINGULAIR PAEDIATRIC
 This medicine is to be given to a child under adult supervision. Your
child should take Singulair Paediatric every evening.
 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 6 months to 5 years of age:
One sachet of Singulair Paediatric 4 mg granules to be taken by mouth
each evening.
If your child is taking Singulair Paediatric, be sure that your child does not
take any other products that contain the same active ingredient,
montelukast.
For children 6 months to 2 years old, Singulair Paediatric 4 mg granules
are available.
For children 2 to 5 years old, Singulair Paediatric 4 mg chewable tablets
and Singulair Paediatric 4 mg granules are available. The Singulair
Paediatric 4 mg granules formulation is not recommended below 6
months of age.

How should I give Singulair Paediatric granules to my child?
 Do not open the sachet until ready to use.
 Singulair Paediatric granules can be given either:
 directly in the mouth;
 OR mixed with a spoonful of cold or room temperature soft food (for
example, applesauce, ice cream, carrots and rice).
 Mix all of the contents of the Singulair Paediatric granules into a
spoonful of cold or room temperature soft food, taking care to see that
the entire dose is mixed with the food.
 Be sure the child is given the entire spoonful of the granule/food
mixture immediately (within 15 minutes). IMPORTANT: Never store
any granule/food mixture for use at a later time.
 Singulair Paediatric granules are not intended to be dissolved in liquid.
However, your child may take liquids after swallowing the Singulair
Paediatric granules.
 Singulair Paediatric granules can be taken without regard to the timing
of food intake.
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 sachet 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.
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 granules, 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:
 diarrhoea
 hyperactivity
 asthma
 scaly and itchy skin
 rash

 dizziness, drowsiness, pins and needles/numbness, seizure
(Uncommon)
 palpitations (Rare)
 nosebleed (Uncommon)
 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); 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.
Ask your doctor or pharmacist for more information about side effects. If
any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your child’s doctor or pharmacist.
5) HOW TO STORE SINGULAIR PAEDIATRIC
 Keep out of the sight and reach of children.
 Do not use this medicine after the date shown by the six numbers
following EXP on the sachet. 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.
 If your granules become discoloured or show any signs of
deterioration, return them to your pharmacist.
6) FURTHER INFORMATION
What Singulair Paediatric contains
 The active substance is montelukast. Each sachet of granules contains
montelukast sodium which corresponds to 4 mg of montelukast.
 The other ingredients are: Mannitol, hyprolose (E463), and magnesium
stearate.
What Singulair Paediatric looks like and contents of the pack
Singulair Paediatric 4 mg granules are white granules.
Singulair Paediatric 4 mg granules come in Cartons of 28 sachets.
SINGULAIR® Paediatric 4 mg Granules PL: 33532/0179
POM

Additionally, the following side effects were reported in clinical studies
with either Singulair 10 mg film-coated tablets, SINGULAIR Paediatric
5 mg or 4 mg chewable tablets:
 abdominal pain
 headache
 thirst

Marketing Authorisation Holder and Manufacturer
Procured from within the EU by the Product Licence holder
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.

These were usually mild and occurred at a greater frequency in patients
treated with Singulair than placebo (a pill containing no medication).

The Manufacturer is Merck Sharp & Dohme BV, PO Box 581,
Waarderweg 39, 2031 BN Haarlem, The Netherlands.

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)

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.

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, sleep walking, irritability, feeling anxious,
restlessness, agitation including aggressive behaviour or hostility,
depression (Uncommon); tremor (Rare); hallucinations, disorientation
suicidal thoughts and actions (Very rare)]

Repackaged by xxxxxxxxxxxxxxxxxxxxxxxxxxxx

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 or MPT Pharma Ltd.)
SINGULAIR® is a registered trademark of Merck Sharp & Dohme Corp
Leaflet dated 25th October 2012
Leaflet coded xxxxxx

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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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