Patient Leaflet Updated 26-May-2020 | Merck Sharp & Dohme Limited
Singulair Paediatric 4 mg tablets
Package leaflet: Information for the user
Singulair® Paediatric 4 mg chewable tablets
montelukast
Read all of this leaflet carefully before you give this medicine to your child because it contains important information.
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.
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:
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
Warnings and precautions
Talk to your doctor or pharmacist before you give Singulair Paediatric to your child.
Patients should be aware that various neuropsychiatric events (for example behaviour and mood-related changes) have been reported in adults, adolescents and children with Singulair (see section 4). If your child develops such symptoms while taking Singulair, you should consult your child’s doctor.
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:
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 and sodium
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).
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
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.
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.
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 (may affect up to 1 in 10 people) thought to be related to Singulair Paediatric were:
Additionally, the following side effect was reported in clinical studies with Singulair 10 mg film-coated tablets and 5 mg chewable tablets:
These were usually mild and occurred at a greater frequency in patients treated with Singulair than placebo (a pill containing no medication).
Serious side effects
Talk with your doctor immediately if you notice any of the following side effects with your child, which may be serious, and for which your child may need urgent medical treatment.
Uncommon: the following may affect up to 1 in 100 people
Rare: the following may affect up to 1 in 1,000 people
Very rare: the following may affect up to 1 in 10,000 people
Other side effects while the medicine has been on the market
Very common: the following may affect more than 1 in 10 people
Common: the following may affect up to 1 in 10 people
Uncommon: the following may affect up to 1 in 100 people
Rare: the following may affect up to 1 in 1,000 people
Very rare: the following may affect up to 1 in 10,000 people
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
6. Contents of the pack and other information
What Singulair Paediatric contains
What Singulair Paediatric looks like and contents of the pack
4 mg Singulair Paediatric chewable tablets are pink, oval, biconvex with SINGULAIR engraved on one side and MSD 711 on the other.
Blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
Blisters (unit dose), in packages of: 49x1, 50x1 and 56x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder:
The manufacturer:
Information is given by:
Alternatively phone the Asthma UK Helpline on 0300 222 5800, Monday to Friday, 9 am to 5 pm.
(Asthma UK is an independent charity working to conquer asthma and is not associated with Merck Sharp & Dohme Limited.)
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Luxemburg, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom
Singulair
This package leaflet was last revised in May 2020
© Merck Sharp & Dohme Limited 2020. All rights reserved.
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