Singulair Paediatric 5mg Chewable Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
SINGULAIR® Paediatric 5mg chewable tablets (montelukast sodium)
Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you or your child.
• 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 you or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or your child's.
• If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• The name of this medicine is SINGULAIR Paediatric 5mg chewable tablets but will be referred to as Singulair or Singulair Paediatric throughout the remainder of this leaflet.
• Singulair ® Paediatric 5mg chewable tablets are also available in other strengths.
What is in this leaflet
1) What Singulair Paediatric is and what it is used for
2) What you need to know before you take 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 asthma, preventing your asthma symptoms during the day and night.
• Singulair Paediatric is used for the treatment of paediatric patients 6 to 14 years of age 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 your 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) WHAT YOU NEED TO KNOW 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 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 or your child take 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.
• 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 antiinflammatory drugs or NSAIDs) if they make your asthma worse.
Children and adolescents
Do not give this medicine to children less than 6 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 you or your child are taking or have recently taken or might take any other medicines including those obtained without a prescription.
Some medicines may affect how Singulair Paediatric works, or Singulair Paediatric may affect how other medicines work.
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)
Singulair Paediatric with food and drink
Singulair Paediatric 5mg 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Singulair Paediatric.
Pregnancy
Your doctor will assess whether you can take Singulair Paediatric during this time.
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 with Singulair Paediatric may affect some patients' ability to drive or operate machinery.
Singulair Paediatric 5mg chewable tablets contain aspartame, a source of phenylalanine
If you or 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 5mg chewable tablet).
3) HOW TO TAKE SINGULAIR PAEDIATRIC
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• You or 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 you or your child has no symptoms or has an acute asthma attack.
For children 6 to 14 years of age:
The recommended dose is one Singulair Paediatric 5 mg chewable tablet daily to be taken in the evening.
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.
This medicine is for oral use.
The tablets are to be chewed before swallowing.
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 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 chewable 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 your or your child's asthma only if you or your child continues to take it.
It is important to continue taking Singulair Paediatric for as long as your doctor prescribes. It will help control your or your child's asthma.
If you have any further questions on the use of this medicine, ask your 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 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: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
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), swelling (inflammation) of the lungs (Very rare)
• 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 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 (See section 2).
Reporting of side effects
If you or your child get 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
By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE SINGULAIR PAEDIATRIC
• Keep out of the sight and reach of children.
• Do not use this medicine after the date shown by the six numbers following EXP on the blister. The first two numbers indicate the month; the last four numbers indicate the year. This medicine expires at the end of the month shown.
• Do not store above 30oC.
• Store in the original package in order to protect from light and moisture.
• 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 your tablets become discoloured or show any sign of deterioration, return them to your pharmacist (chemist).
6) CONTENTS OF THE PACK AND OTHER INFORMATION What SINGULAIR Paediatric contains:
Each chewable tablet contains montelukast sodium 5.2mg, equivalent to 5mg montelukast.
The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose (E463), 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 5 mg chewable tablets are pink, round, biconvex with SINGULAIR engraved on one side, MSD 275 on the other
SINGULAIR Paediatric 5 mg chewable tablets come in packs of 28 tablets.
Manufactured by
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by xxxxxxxxxxx.
PL: 33532/0152
POM
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.
(The Asthma UK and The Asthma Society of Ireland are independent charities working to conquer asthma and are not associated with Merck Sharp & Dohme Limited or MPT Pharma Ltd.)
Leaflet dated 11th August 2016 Leaflet coded xxxxxx
SINGULAIR® is a registered trademark of Merck Sharpe & Dohme Corp.