Singulair Paediatric 4 mg tablets

Read all of this leaflet carefully before you give this medicine to your child because it contains important information.

• 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 your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
• If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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 2 to 5 year 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 2 to 5 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 for patients 2 years 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.

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 give Singulair 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 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.
• 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 (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:

• 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 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 (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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.

Serious side effects

Talk with your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment.

Uncommon: the following may affect up to 1 in 100 people

• 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 1 in 1,000 people

• increased bleeding tendency
• tremor
• palpitations

Very rare: the following may affect up to 1 in 10,000 people

• 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 1 in 10 people

• upper respiratory infection

Common: the following may affect up to 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• elevated liver enzymes

Uncommon: the following may affect up to 1 in 100 people

• 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 1 in 1,000 people

• behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements

Very rare: the following may affect up to 1 in 10,000 people

• 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.

What Singulair Paediatric contains

• The active substance is montelukast. Each chewable tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
• The other ingredients are:
  Mannitol (E 421), microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour, aspartame (E 951), and magnesium stearate.

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