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Singulair Paediatric 4mg Chewable Tablets

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• 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 your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as 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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

SINGULAIR® PAEDIATRIC 4mg CHEWABLE TABLETS

(montelukast sodium)

The name of your medication is Singulair Paediatric 4 mg Chewable Tablets, however it will be called Singulair throughout this leaflet.

Read all of this leaflet carefully before your child starts taking this medicine.

In this leaflet:

1. What Singulair is and what it is used for

2. Before Singulair is taken

3. How to take Singulair

4. Possible side effects

5. How to store Singulair

6. Further information

1. WHAT SINGULAIR IS AND WHAT IT IS USED FOR

Singulair is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Singulair improves asthma symptoms and helps control asthma.

Your doctor has prescribed Singulair to treat your child's asthma, preventing asthma symptoms during the day and night.

• Singulair 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 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 also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.

Your doctor will determine how Singulair 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.

• It is important that your child take all asthma medications prescribed by your doctor. Singulair 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 antiinflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.

Taking other medicines

Some medicines may affect how Singulair works, or Singulair may affect how your child's other medicines work.

Please tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including those obtained without a prescription.

Tell your doctor if your child is taking the following medicines before starting Singulair:

• phenobarbital (used for treatment of epilepsy)

• phenytoin (used for treatment of epilepsy)

• rifampicin (used to treat tuberculosis and some other infections)

Taking Singulair 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 two 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, however the following information is relevant to the active ingredient, montelukast.

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 breastfeed.

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

Singulair 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 tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per tablet).

3. HOW TO TAKE SINGULAIR

2. BEFORE SINGULAIR IS TAKEN

Tell your doctor about any medical problems or allergies your child has

now or has had.

Do not give Singulair to your child if he/she

• is allergic (hypersensitive) to montelukast or any of the other ingredients of Singulair (see 6. Further information).

Take special care with Singulair

• If your child's asthma or breathing gets worse, tell your doctor immediately.

• Oral Singulair 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.

• 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 tablet of Singulair 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.

• Always have your child take Singulair as your doctor has told you. You should check with your child's doctor or pharmacist if you are not sure.

• To be taken by mouth

POM

One Singulair tablet daily to be taken in the evening. Singulair should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.

If your child is taking Singulair, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.

For children 2 to 5 years old, Singulair Paediatric 4 mg Chewable Tablets and 4 mg granules are available.

For children 6 to 14 years old, Singulair Paediatric 5 mg Chewable Tablets are available. The Singulair Paediatric 4 mg Chewable Tablet is not recommended below 2 years of age.

If your child takes more Singulair 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 to your child

Try to give Singulair as prescribed. However, if your child misses a dose, just resume the usual schedule of one tablet once daily.

Do not give a double dose to make up for a forgotten dose.

If your child stops taking Singulair

Singulair can treat your child's asthma only if he/she continues taking it.

It is important for your child to continue taking Singulair 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 product, ask your child's doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Singulair can cause side effects, although not everybody gets them.

In clinical studies with Singulair, 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 were:

• abdominal pain

• thirst

Additionally, the following side effect was reported in clinical studies with Singulair 10 mg film-coated tablets and Singulair Paediatric 5 mg 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).

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 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 your child gets 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 child's doctor or pharmacist.

5. HOW TO STORE SINGULAIR

• 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.

• Store in the original package in order to protect from light and moisture.

• Do not store above 30°C.

• 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.

6. FURTHER INFORMATION

What Singulair contains

• The active substance is: montelukast. Singulair contains 4.2mg montelukast sodium which corresponds to 4mg of montelukast.

• The other ingredients are:

Mannitol (E421), microcrystalline cellulose (E460), hydroxypropyl cellulose, red ferric oxide (E172) croscarmellose sodium, cherry flavour, aspartame (E951) and magnesium stearate (E572).

What Singulair looks like and contents of the pack

Singulair are pink, oval, bi-convex shaped tablets with ‘SINGULAIR' engraved on one side and ‘MSD 711' on the other.

In packs of: 28 tablets.

Manufacturer

The manufacturer is Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, Holland. Procured from within the EU and repackaged in the UK for the Parallel Import Product Licence holder: CD Pharma Ltd, Unit 3 Manor Point, Manor Way, Borehamwood, Herts WD6 1EE.

Singulair Paediatric 4mg Chewable Tablets PL No. 20492/0111

Information is given by:

In UK: Asthma UK, Providence House, Providence Place, London N1 0NT. 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.)

Date of preparation: 30^th September 2013

Singulair is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA

• 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 your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as 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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST PAEDIATRIC 4mg CHEWABLE TABLETS

(montelukast sodium)

The name of your medication is Montelukast Paediatric 4 mg Chewable Tablets, however it will be called Montelukast throughout this leaflet.

Read all of this leaflet carefully before your child starts taking this medicine.

In this leaflet:

1. What Montelukast is and what it is used for

2. Before Montelukast is taken

3. How to take Montelukast

4. Possible side effects

5. How to store Montelukast

6. Further information

1. WHAT MONTELUKAST IS AND WHAT IT IS USED FOR

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast improves asthma symptoms and helps control asthma.

Your doctor has prescribed Montelukast to treat your child's asthma, preventing asthma symptoms during the day and night.

• Montelukast is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.

• Montelukast 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.

• Montelukast also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.

Your doctor will determine how Montelukast 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. BEFORE MONTELUKAST IS TAKEN

Tell your doctor about any medical problems or allergies your child has

now or has had.

Do not give Montelukast to your child if he/she

• is allergic (hypersensitive) to montelukast or any of the other ingredients of Montelukast (see 6. Further information).

Take special care with Montelukast

• If your child's asthma or breathing gets worse, tell your doctor immediately.

• Oral Montelukast 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. Montelukast should not be used instead of other asthma medications your doctor has prescribed for your child.

• Your child should not take acetyl-salicylic acid (aspirin) or antiinflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.

Taking other medicines

Some medicines may affect how Montelukast works, or Montelukast may affect how your child's other medicines work.

Please tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including those obtained without a prescription.

Tell your doctor if your child is taking the following medicines before starting Montelukast:

• phenobarbital (used for treatment of epilepsy)

• phenytoin (used for treatment of epilepsy)

• rifampicin (used to treat tuberculosis and some other infections)

Taking Montelukast with food and drink

Montelukast Paediatric 4 mg Chewable Tablets should not be taken immediately with food; they should be taken at least 1 hour before or two hours after food.

Pregnancy and breast-feeding

This subsection is not applicable for the Montelukast 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.

Use in pregnancy

Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast. Your doctor will assess whether you can take Montelukast during this time.

Use in breast-feeding

It is not known if Montelukast appears in breast milk. You should consult your doctor before taking Montelukast if you are breast-feeding or intend to breast-feed.

Driving and using machines

Montelukast 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 Montelukast may affect some patients' ability to drive or operate machinery.

Important information about some of the ingredients of Montelukast

Montelukast 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 Montelukast tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per tablet).

3. HOW TO TAKE MONTELUKAST

• 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 tablet of Montelukast 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.

• Always have your child take Montelukast as your doctor has told you. You should check with your child's doctor or pharmacist if you are not sure.

• To be taken by mouth

One Montelukast tablet daily to be taken in the evening. Montelukast should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.

If your child is taking Montelukast, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.

For children 2 to 5 years old, Montelukast Paediatric 4 mg Chewable Tablets and 4 mg granules are available.

For children 6 to 14 years old, Montelukast Paediatric 5 mg Chewable Tablets are available. The Montelukast Paediatric 4 mg Chewable Tablet is not recommended below 2 years of age.

If your child takes more Montelukast than he/she should

Contact your child's doctor immediately for advice.

If you forget to give Montelukast to your child

Try to give Montelukast as prescribed. However, if your child misses a dose, just resume the usual schedule of one tablet once daily.

Do not give a double dose to make up for a forgotten dose.

If your child stops taking Montelukast

Montelukast can treat your child's asthma only if he/she continues taking it.

It is important for your child to continue taking Montelukast for as long as your doctor prescribes. It will help control your child's asthma.

• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)

• hepatitis (inflammation of the liver) (Very rare)

• joint or muscle pain, muscle cramps (Uncommon)

• fever (Common); weakness/tiredness, feeling unwell, swelling (Uncommon).

5. HOW TO STORE MONTELUKAST

• Keep out of the sight and reach of children.

• Store in the original package in order to protect from light and moisture.

• Do not store above 30°C.

• 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.

6. FURTHER INFORMATION

What Montelukast contains

If you have any further questions on the use of this product, ask your child's doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

POM

Like all medicines, Montelukast can cause side effects, although not everybody gets them.

In clinical studies with Montelukast, 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 Montelukast were:

• abdominal pain

• thirst

Additionally, the following side effect was reported in clinical studies with Montelukast 10 mg film-coated tablets and Montelukast Paediatric 5 mg chewable tablets:

• headache

These were usually mild and occurred at a greater frequency in patients treated with Montelukast 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)

• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)

• palpitations (Rare)

• nosebleed (Uncommon)

The active substance is: montelukast. Montelukast contains 4.2mg montelukast sodium which corresponds to 4mg of montelukast.

• The other ingredients are:

Mannitol (E421), microcrystalline cellulose (E460), hydroxypropyl cellulose, red ferric oxide (E172) croscarmellose sodium, cherry flavour, aspartame (E951) and magnesium stearate (E572).

What Montelukast looks like and contents of the pack

Montelukast are pink, oval, bi-convex shaped tablets with ‘MONTELUKAST engraved on one side and ‘MSD 711' on the other.

In packs of: 28 tablets.

Manufacturer

Montelukast Paediatric 4mg Chewable Tablets PL No. 20492/0111

Information is given by:

In UK: Asthma UK, Providence House, Providence Place, London N1 0NT. Alternatively phone the Asthma Uk Adviceline on 08457 010203, Monday to Friday 9 am to 5 pm, calls charged at local rate.

(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.)

Date of preparation: 30^th September 2013