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Singulair Paediatric 5mg Chewable Tablets

Informations for option: Singulair Paediatric 5mg Chewable Tablets, show other option
Document: leaflet MAH BRAND_PLPI 19488-1688 change

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.


S1688 LEAFLET Singulair 20160624

PACKAGE LEAFLET: INFORMATION FOR THE USER SINGULAIR® PAEDIATRIC 5mg CHEWABLE TABLETS (montelukast sodium)

Your medicine is known as Singulair Paediatric 5mg Chewable Tablets but will be referred to as Singulair throughout the following leaflet.

What is in this leaflet

1.    What Singulair is and what it is used for

2.    What you need to know before you take Singulair

3.    How to take Singulair

4.    Possible side effects

5.    How to store Singulair

6.    Contents of the pack and other information

1. WHAT SINGULAIR IS AND WHAT IT IS USED FOR

What Singulair is

Singulair is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Singulair works

Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Singulair improves asthma symptoms and helps control asthma.

When Singulair should be used

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

•    Singulair 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 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 also helps prevent the narrowing of airways triggered by exercise.

Your doctor will determine how Singulair 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

Tell your doctor about any medical problems or allergies you or your child has now or has had.

Do not take Singulair

• 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.

•    If you or 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 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 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 anti-inflammatory medicines (also known as non-steroidal anti-inflammatory 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

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 works, or Singulair may affect how other medicines work.

Tell your doctor if you or 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)

Singulair with food and drink

Singulair 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.

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.

Pregnancy

Your doctor will assess whether you can take Singulair during this time.

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 breast-feed.

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

Singulair 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 5 mg chewable tablet contains phenylalanine (equivalent to 0.842 mg phenylalanine per 5 mg chewable tablet).

3. HOW TO TAKE SINGULAIR

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 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 5 mg chewable tablet daily to be taken in the evening.

If you or your child is taking Singulair, 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 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 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 or give Singulair to your child

Try to take Singulair 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

Singulair can treat you or your child's asthma only if you or your child continues to take it.

It is important to continue taking Singulair for as long as your doctor prescribes. It will help control you 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 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 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

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 30 °C. Store in the original package in order to protect from light and moisture.

•    Do not use after the expiry date printed on the carton label or blister strip.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Singulair contains

•    Each chewable tablet contains montelukast sodium 5.2mg, which is equivalent to 5mg montelukast.

•    Singulair also contains the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose (E 463), iron oxide red (E172), croscarmellose sodium, cherry flavor, aspartame (E951), and magnesium stearate.

What Singulair looks like and contents of the pack

•    Singulair is pink, round, biconvex tablets with Singulair engraved on one side, MSD 275 on the other.

•    Singulair is available as blister packs of 28 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands.

| POM | PL: 19488/1688

Leaflet revision date: 24 June 2016

Singulair is a registered trade mark of Merck & Co., Inc.,

Whitehouse Station, NJ USA.

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.)

S1688 LEAFLET Singulair 20160624

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.


S1688 LEAFLET Montelukast 20160624

PACKAGE LEAFLET: INFORMATION FOR THE USER MONTELUKAST PAEDIATRIC 5mg CHEWABLE TABLETS

(montelukast sodium)

Your medicine is known as Montelukast Paediatric 5mg Chewable Tablets but will be referred to as Montelukast Tablets throughout the following leaflet.

What is in this leaflet

1.    What Montelukast Tablets are and what they are used for

2.    What you need to know before you take Montelukast Tablets

3.    How to take Montelukast Tablets

4.    Possible side effects

5.    How to store Montelukast Tablets

6.    Contents of the pack and other information

1. WHAT MONTELUKAST TABLETS ARE AND WHAT THEY ARE USED FOR

What Montelukast Tablets are

Montelukast Tablets are a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Montelukast Tablets work

Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast Tablets improves asthma symptoms and helps control asthma.

When Montelukast Tablets should be used

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

•    Montelukast Tablets are 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.

•    Montelukast Tablets 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.

•    Montelukast Tablets also helps prevent the narrowing of airways triggered by exercise.

Your doctor will determine how Montelukast Tablets 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 MONTELUKAST TABLETS

Tell your doctor about any medical problems or allergies you or your child has now or has had.

Do not take Montelukast Tablets

• 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 Montelukast Tablets.

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

•    Oral Montelukast Tablets are 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. Montelukast Tablets 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 anti-inflammatory medicines (also known as non-steroidal anti-inflammatory 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 Montelukast Tablets

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 Montelukast Tablets works, or Montelukast Tablets may affect how other medicines work.

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

•    phenobarbital (used for treatment of epilepsy)

•    phenytoin (used for treatment of epilepsy)

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

Montelukast Tablets with food and drink

Montelukast Tablets 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.

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 Montelukast Tablets.

Pregnancy

Your doctor will assess whether you can take Montelukast Tablets during this time.

Breast-feeding

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

Driving and using machines

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

Montelukast Tablets 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 Montelukast Tablets 5 mg chewable tablet contains phenylalanine (equivalent to 0.842 mg phenylalanine per 5 mg chewable tablet).

3. HOW TO TAKE MONTELUKAST TABLETS

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 Montelukast Tablets 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 Montelukast Tablets 5 mg chewable tablet daily to be taken in the evening.

If you or your child is taking Montelukast Tablets, 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. Montelukast Tablets 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 Montelukast Tablets 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 Montelukast Tablets or give Montelukast Tablets to your child

Try to take Montelukast Tablets 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 Montelukast Tablets

Montelukast Tablets can treat you or your child's asthma only if you or your child continues to take it.

It is important to continue taking Montelukast Tablets for as long as your doctor prescribes. It will help control you 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 Montelukast Tablets 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 Montelukast Tablets were:

•    headache

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

•    abdominal pain

These were usually mild and occurred at a greater frequency in patients treated with Montelukast Tablets 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 MONTELUKAST TABLETS

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 30 °C. Store in the original package in order to protect from light and moisture.

•    Do not use after the expiry date printed on the carton label or blister strip.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Montelukast Tablets contain

•    Each chewable tablet contains montelukast sodium 5.2mg, which is equivalent to 5mg montelukast.

•    Montelukast Tablets also contains the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose (E 463), iron oxide red (E172), croscarmellose sodium, cherry flavor, aspartame (E951), and magnesium stearate.

What Montelukast Tablets look like and contents of the pack

•    Montelukast Tablets are pink, round, biconvex tablets with Montelukast Tablets engraved on one side, MSD 275 on the other.

•    Montelukast Tablets are available as blister packs of 28 tablets. Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands.

| POM | PL: 19488/1688 Leaflet revision date: 24 June 2016

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.)

S1688 LEAFLET Montelukast 20160624