Patient leaflet - Singulair paediatric 4 mg chewable tablets
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. • Singulair Paediatric is used for the treatment of 2to 5year
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 2to 5year 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 2years 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. 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
if he/she is allergic to montelukast or any of the other
ingredients of this medicine (listed in section 6). Warnings and precautions
Talk to your doctor or pharmacist before you giveSingulair Paediatric to your child.
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 asflu-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
anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.
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 (seesection 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 2years of age. There are different form(s) of this medicine available for paediatric patients under 18years 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, orSingulair Paediatric may affect how your child’s other medicineswork.
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) Singulair Paediatric with food and drink
Singulair Paediatric 4mg chewable tablets should not be taken immediately with food; they should be taken at least 1hour before or 2hours after food.
Pregnancy and breast-feeding
This subsection is not applicable for the Singulair Paediatric 4mg chewable tablets since they are intended for use in children 2to5years of age.
Driving and using machines
This subsection is not applicable for the Singulair Paediatric 4mg chewable tablets since they are intended for use in children 2to5years 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 4mg chewable tablets contain aspartame, sodium and benzyl alcohol
This medicine contains 1.2 mg aspartame in each 4 mg chewable tablet which is equivalent to 0.674 mg phenylalanine. Aspartame is a source of phenylalanine. It may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
This medicine contains up to 0.36 mg benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if your child has a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in the body and may cause side effects (called “metabolic acidosis”).
Do not use for more than a week in young children (less than 3 years old) unless advised by your doctor or pharmacist.
3. How to takeSingulairPaediatric
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.
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 chewable 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.
For children 2to 5years of age:
The recommended dose is one 4mg 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 4mg chewable tablets should not be taken immediately with food; it should be taken at least 1hour before or2hours 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, askyour 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 4mg chewable tablets, the most commonly reported side effects (may affect up to 1in10people) thought to be related to Singulair Paediatric were: • abdominal pain
- thirst
Additionally, the following side effect was reported in clinical studies with Singulair 10mg film-coated tablets and 5mg chewable tablets:
- headache
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 1in 100people • allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
- behaviour and mood related changes: agitation including aggressive behaviour or hostility, depression
- seizure
Rare: the following may affect up to 1in 1,000people • increased bleeding tendency
- tremor
- palpitations
Very rare: the following may affect up to 1in 10,000people • 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) (see section 2)
- low blood platelet count
- behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and actions
- swelling (inflammation) of the lungs
- severe skin reactions (erythema multiforme) that may occur without warning
- inflammation of the liver (hepatitis)
Other side effects while the medicine has been on the market
Very common: the following may affect more than 1in 10people • upper respiratory infection
Common: the following may affect up to 1in 10people • diarrhoea, nausea, vomiting
- rash
- fever
- elevated liver enzymes
Uncommon: the following may affect up to 1in 100people • behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness
- dizziness, drowsiness, pins and needles/numbness • nosebleed
- dry mouth, indigestion
- bruising, itching, hives
- joint or muscle pain, muscle cramps
- bedwetting in children
- weakness/tiredness, feeling unwell, swelling
Rare: the following
may affect up to
1in1,000people
behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements Very rare: the following may affect up to 1in 10,000people • tender red lumps under the skin, most commonly on your shins
(erythema nodosum)
- behaviour and mood related changes: obsessive-compulsive symptoms, stuttering
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
- Keep this medicine out of the sight and reach of children. • Do not use this medicine after the expiry date which is stated on the blister after EXP. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date refers to the last date of that month.
- Store in the original package in order to protect from light and moisture.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Singulair Paediatric contains
- The active substance is montelukast. Each chewable tablet contains montelukast sodium which corresponds to 4mg of montelukast.
The other ingredients are:
Mannitol (E 421), microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour containing benzyl alcohol (E1519), aspartame (E 951), and magnesium stearate.
What Singulair Paediatric looks like and contents of the pack
4mg Singulair Paediatric chewable tablets are pink, oval, biconvex with SINGULAIR engraved on one side and MSD 711on the other. Blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140and 200tablets.
Blisters (unit dose), in packages of: 49x1, 50x1and 56x1tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder:
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire, EN119BU, UK.
The manufacturer:
Merck Sharp & Dohme BV, Waarderweg 39, PO Box 581, 2003PCHaarlem, The Netherlands.
Information is given by:
Asthma UK, 18Mansell Street, London, E18AA. Alternatively phone the Asthma UK Helpline on 03002225800, Monday to Friday, 9amto 5pm.
(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 ofthe 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 October 2020 © Merck Sharp & Dohme Limited 2020. All rights reserved. PIL.SGA-4mg.20.UK.7288.WS-086.RCN012471
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