MONTELUKAST PAEDIATRIC 5MG CHEWABLE TABLETS

Active substance: MONTELUKAST SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR PAEDIATRIC 5 mg CHEWABLE TABLETS /
MONTELUKAST PAEDIATRIC 5 mg CHEWABLE TABLETS
(montelukast sodium)
This product is available as either of the above names but will be referred to as Singulair Paediatric 5mg
Chewable Tablet throughout the following 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 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 5mg Chewable Tablet is and what it is used for
2. Before you take Singulair Paediatric 5mg Chewable Tablet
3. How to take Singulair Paediatric 5mg Chewable Tablet
4. Possible side effects
5. How to store Singulair Paediatric 5mg Chewable Tablet
6. Further information
1. WHAT SINGULAIR PAEDIATRIC 5mg CHEWABLE TABLET IS AND WHAT IT IS USED FOR
Singulair Paediatric 5mg Chewable Tablet 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 5mg Chewable Tablet improves asthma symptoms and helps control asthma.
Your doctor has prescribed Singulair Paediatric 5mg Chewable Tablet to treat asthma, preventing your
asthma symptoms during the day and night.
• Singulair Paediatric 5mg Chewable Tablet is used for the treatment of patients who are not adequately

controlled on their medication and need additional therapy.

• Singulair Paediatric 5mg Chewable Tablet 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 5mg Chewable Tablet also helps prevent the narrowing of airways triggered by exercise.
Your doctor will determine how Singulair Paediatric 5mg Chewable Tablet 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 5mg CHEWABLE TABLET
Tell your doctor about any medical problems or allergies you or your child has now or has had.
Do not take Singulair Paediatric 5mg Chewable Tablet if you or your child
• is allergic (hypersensitive) to montelukast or any of the other ingredients of Singulair Paediatric 5mg
Chewable Tablet (see 6. Further information).
Take special care with Singulair Paediatric 5mg Chewable Tablet

• If you or your child’s asthma or breathing gets worse, tell your doctor immediately.
• Oral Singulair Paediatric 5mg Chewable Tablet 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 5mg Chewable Tablet should not be used instead of other asthma medications your doctor
has prescribed for you or your child.
• 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 anti-inflammatory 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 5mg Chewable Tablet works, or Singulair Paediatric
5mg Chewable Tablet 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.
Tell your doctor if you or your child is taking the following medicines before starting Singulair Paediatric 5mg
Chewable Tablet:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Taking Singulair Paediatric 5mg Chewable Tablet with food and drink
Singulair Paediatric 5 mg Chewable Tablets should not be taken immediately with food; it should be taken at
least 1 hour before or 2 hours after food.
Pregnancy and breast-feeding
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
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 5mg Chewable Tablet
Singulair Paediatric 5mg Chewable Tablet 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 5 mg Chewable Tablet contains phenylalanine (equivalent to 0.842 mg phenylalanine
per 5 mg chewable tablet).
3. HOW TO TAKE SINGULAIR PAEDIATRIC 5mg CHEWABLE TABLET
• You or your child should take only one tablet of Singulair Paediatric 5mg Chewable Tablet 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 5mg Chewable Tablet as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
• To be taken by mouth

For children 6 to 14 years of age:
One Singulair Paediatric 5 mg Chewable Tablet daily to be taken in the evening. Singulair Paediatric 5 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 you or your child is taking Singulair Paediatric 5mg Chewable Tablet, 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 5mg Chewable Tablet 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 5mg Chewable Tablet or give Singulair Paediatric 5mg
Chewable Tablet to your child
Try to take Singulair Paediatric 5mg Chewable Tablet 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 5mg Chewable Tablet
Singulair Paediatric 5mg Chewable Tablet can treat you or your child’s asthma only if you or your child
continues to take it.
It is important to continue taking Singulair Paediatric 5mg Chewable Tablet 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 5mg Chewable Tablet 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 5mg Chewable Tablet 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, 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)
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)

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flulike 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 5mg CHEWABLE TABLET
• Keep out of the sight and reach of children.
• Store in the original package.
• Do not store above 30°C. Store in the original container to protect from moisture and light.
• Do not give the tablets to your child if they have passed the expiry date, which is clearly marked on the pack.
• This medicine is for your child only. It should not be shared with anyone else.
• 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 the tablets become discoloured or show any signs of deterioration, consult your pharmacist who will
advise you what to do.
6. FURTHER INFORMATION
What is in your child's tablets?
Active Ingredient:
The active ingredient in Singulair Paediatric 5mg Chewable Tablets is montelukast.
Each tablet is pink, round, biconvex tablet marked '275' on one side and plain on the other side and contains
5.2 mg montelukast sodium equivalent to 5 mg montelukast.
Other ingredients: Mannitol (E421), microcrystalline cellulose (E460), hydroxypropyl cellulose, red ferric
oxide (E172) (colouring agent), croscarmellose sodium, cherry flavour, aspartame (E951) and magnesium
stearate (E572).
Singulair Paediatric 5mg Chewable Tablets are available in calendar blister packs of 28 tablets.
PL No: 15814/0734

Singulair Paediatric 5 mg Chewable Tablets / Montelukast Paediatric 5 mg
Chewable Tablets
POM
Singulair Paediatric 5mg Chewable Tablet is manufactured by Merck Sharp and Dohme Ltd, Shotton Lane,
Cramlington, Northumberland NE23 3JU, UK and procured from within the EU and repackaged by the
Product licence holder who is: OPD Laboratories Ltd., Unit 6, colonial Way, Watford, Herts WD2 4PR.
Leaflet revision and issue date (ref) 04/09/2013

Singulair is a registered Trade Mark of Merck Sharp & Dohme Corp., New Jersey, U.S.A.
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.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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