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MONTEGEN PAEDIATRIC 5MG CHEWABLE TABLETS

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Singulair® Paediatric 5mg Chewable Tablets
Montegen® Paediatric 5mg Chewable Tablets
(montelukast sodium)
Your medicine is known by either of the above names, but will be referred to
as Singulair Paediatric throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you or 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 you or your child. Do not pass it on to
others. It may harm them, even if their symptoms are the same as your or
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 you take Singulair Paediatric
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

 Any patient on anti-asthma medicines should be aware that if you develop
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.
 You or 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 your asthma worse.
Use in children
For children 2 to 5 years old, Singulair Paediatric 4 mg chewable tablets
and Singulair Paediatric 4 mg granules are available.
For children 6 to 14 years old, Singulair Paediatric 5 mg chewable tablets
are available.
Taking other medicines
Some medicines may affect how Singulair Paediatric works, or Singulair
Paediatric may affect how other medicines work.
Please tell your doctor or pharmacist if you or your child is taking or has
recently taken other medicines, including those obtained without a
prescription.

Singulair Paediatric is a leukotriene receptor antagonist that blocks
substances called leukotrienes.
Leukotrienes cause narrowing and swelling of airways in your lungs. By
blocking leukotrienes, Singulair Paediatric improves asthma symptoms and
helps control asthma.

Tell your doctor if you or 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)

Your doctor has prescribed Singulair Paediatric to treat asthma, preventing
your asthma symptoms during the day and night.

Taking Singulair Paediatric with food and drink
Singulair Paediatric should not be taken immediately with food; it should be
taken at least 1 hour before or 2 hours after food.

 Singulair Paediatric is used for the treatment of 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 6 to 14 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.
Your doctor will determine how Singulair Paediatric should be used
depending on the symptoms and severity of you or 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 you take Singulair Paediatric
Tell your doctor about any medical problems or allergies you or your child
has now or has had.
Do not take Singulair Paediatric if you or your child
 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 you or 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 or your
child. Always have your inhaled rescue medicine for asthma attacks with
you.
 It is important that you or 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 you or your
child.

Pregnancy and breast-feeding
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
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 5mg chewable
tablet contains phenylalanine (equivalent to 0.842 mg phenylalanine per 5
mg chewable tablet).

3) How to take Singulair Paediatric
 You or your child should take only one tablet of Singulair Paediatric once
a day as prescribed by your doctor.
 It should be taken even when you or your child has no symptoms or has
an acute asthma attack.
 Always take Singulair Paediatric as your doctor has told you. You should
check with your 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 6 to 14 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 you or your child is taking Singulair Paediatric, be sure that you or your
child does not take any other products that contain the same active
ingredient, montelukast.
If you or your child takes more Singulair Paediatric than you should
Contact your 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 take Singulair Paediatric or give Singulair Paediatric to
your child
Try to take Singulair Paediatric as prescribed. However, if you or your child
misses a dose, just resume the usual schedule of one tablet once daily.
Do not take a double dose to make up for a forgotten dose.
If you or your child stops taking Singulair Paediatric
Singulair Paediatric can treat you or your child’s asthma only if you or your
child continues take it.
It is important to continue taking Singulair Paediatric for as long as your
doctor prescribes. It will help control you or your child’s asthma.
If you have any further questions on the use of this product, ask your 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 5 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:
 headache
Additionally, the following side effect was reported in clinical studies with
Singulair 10 mg film coated tablets:
 abdominal pain
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, sleep walking, irritability, feeling anxious,
restlessness, agitation including aggressive behaviour or hostility,
depression (Uncommon); tremor (Rare); hallucinations, disorientation,
suicidal thoughts and actions (Very rare)]
 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 reaction (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 you get 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.
 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.

6) Further information
What Singulair Paediatric contains:
The active ingredient is montelukast.
Each tablet contains 5mg of the active ingredient montelukast (as
montelukast sodium).
Each tablet also contains mannitol, microcrystalline cellulose, hydroxypropyl
cellulose, 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 5mg Chewable Tablets are pink, round, biconvex with
‘275’ engraved on one side and plain on the other.
Singulair Paediatric 5mg Chewable Tablets are available as calendar blister
packs of 28 tablets.
PL 10383/1695

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Merck Sharp & Dhome 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.
Leaflet date: 08.10.2012
Information is given by:
In UK: Asthma UK, Providence House, Providence Place, London N1 ONT.
Alternatively phone the
Asthma UK Advice line 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 call save 1850 44 5464.
(The Asthma UK and The Asthma Society of Ireland are independent
charities working to conquer asthma and are not associated with the PLPI
Company.)

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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