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MONTEGEN PAEDIATRIC 4MG CHEWABLE TABLETS

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Singulair® Paediatric 4mg Chewable Tablets
Montegen® Paediatric 4mg Chewable Tablets
(montelukast sodium)
Your medicine is known by the above names, but will be referred to as
Singulair Paediatric throughout this:
Patient Information Leaflet
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, 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 get 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 years 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 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 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 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 Paediatric. Your doctor will assess
whether you can take Singulair Paediatric during this time.
Use in breast-feeding
It is not known if Singulair Paediatric appears in breast milk. You should
consult your doctor before taking Singulair Paediatric if you are breastfeeding or intend to breast-feed.
Driving and using machines
This subsection is not applicable for the Singulair Paediatric 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 very rarely with Singulair Paediatric may affect some patients’
ability to drive or operate machinery.
Important information about some of the ingredients of Singulair
Paediatric
Singulair Paediatric contains 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 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

The translation of the days of the week on the blister strip is as follows:
Mon Tue
Wed Thu
Fri
Sat
Sun
Lun
Mar
Mer
Gio
Ven
Sab
Dom
For children 2 to 5 years of age:
One Singulair Paediatric daily to be taken in the evening. Singulair
Paediatric should not be taken immediately with food; it should be taken at
least 1 hour before or 2 hours after food.
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 and 4 mg granules are
available.
For children 6 to 14 years old, Singulair Paediatric 5 mg chewable tablets
are available. The Singulair Paediatric 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 your child continues
to take 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.











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 doctor or pharmacist.

5) How to store Singulair Paediatric
• Keep all medicines out of the sight and reach of children.
• Do not take Singulair Paediatric after the expiry date printed on the
carton, label or blister strip. The expiry date refers to the last day of the
month.
• Store in the original package to protect from light and moisture.
• Do not put the tablets into another container, as they might get mixed up.
Do not remove the tablet from the calendar pack until you are ready to
take it.
• If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.
• Medicines should not be thrown in your bin or put down the drain. If they
are out of date, or no longer suitable for you, return them to your
pharmacist for safe disposal.

If you have any further questions on the use of this product, ask your child’s
doctor or pharmacist.

6) Further information

4) Possible side effects

What Singulair Paediatric contains:
The active ingredient is montelukast.

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 5mg chewable tablets:
• headache

Each tablet contains 4mg of the active ingredient montelukast (as
montelukast sodium).
Each tablet also contains mannitol (E421), microcrystalline cellulose (E460),
hydroxypropyl cellulose, red iron oxide (E172) croscarmellose sodium,
cherry flavour, aspartame (E951) and magnesium stearate (E572).
What Singulair Paediatric looks like and contents of the pack
Singulair Paediatric 4mg Chewable Tablets are oval bi-convex shaped
tablets with ‘117’ engraved on one side and plain on the other.
Singulair Paediatric 4mg Chewable Tablets are available as calendar blister
packs of 28 tablets.

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

PL 10383/1691

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)

Who makes and repackages your medicine?
Your medicine is manufactured by Merck Sharp & Dohme Limited, Shotton
Lane, Cramlington, Northumberland, NE23 3JU, UK. Procured from within
the EU and repackaged by Product Licence Holder: Primecrown Ltd., 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

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)]

Singulair Paediatric 4mg Chewable Tablets/
Montegen Paediatric 4mg Chewable Tablets

POM

Leaflet date: 12.11.2012
Further information about asthma is available in the UK from:
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.
(Asthma UK is an independent charity working to conquer asthma and are
not associated with Merck Sharp & Dohme Limited or Primecrown Ltd.)
®

®

Singulair and Montegen are registered trademarks of Merck Sharp &
Dohme Corp., Whitehouse Station, NJ, USA.

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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