Montelukast 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.
• 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 you or your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours or your child’s.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is SINGULAIR Paediatric 5mg
Chewable Tablets but it will be referred to as Singulair or
Singulair Paediatric throughout this leaflet.
In this leaflet:
1. What Singulair Paediatric is and what it is used for
2. Before you take Singulair Paediatric
3. How to take Singulair Paediatric
4. Possible side effects
5. How to store Singulair Paediatric
6. Further information
1. WHAT SINGULAIR PAEDIATRIC IS AND WHAT IT IS USED FOR
Singulair Paediatric is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs.
By blocking leukotrienes, Singulair Paediatric improves asthma symptoms and helps control asthma.
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 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 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 you 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. 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 (hypersensitive) to montelukast or any of the other ingredients of Singulair Paediatric (see 6. 'Further information').
Take special care with 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 anti-inflammatory medicines (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
Use in children
For children 2 to 5 years old, Singulair Paediatric 4mg chewable tablets and Singulair Paediatric 4mg granules are available.
For children 6 to 14 years old, Singulair Paediatric 5mg chewable tablets are available.
Taking other medicines
Some medicines may affect how Singulair Paediatric works, or Singulair Paediatric may affect how other medicines work. Please tell your doctor or pharmacist if you or your child is taking or has recently taken other medicines, including those obtained without a prescription.
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)
Taking Singulair Paediatric with food and drink
Singulair Paediatric 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
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 breastfeeding 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 very rarely with Singulair may affect some patients' ability to drive or operate machinery.
Important information about some of the ingredients of Singulair Paediatric
Singulair Paediatric 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 Paediatric contains phenylalanine (equivalent to 0.842mg phenylalanine per 5mg chewable tablet).
3. HOW TO TAKE SINGULAIR PAEDIATRIC
• You or your child should take only one 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.
• Always take Singulair Paediatric as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• To be taken by mouth.
For children 6 to 14 years of age:
One Singulair Paediatric daily to be taken in the evening. Singulair Paediatric should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
The tablets are to be chewed before swallowing.
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.
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 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 you 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 you or your child's asthma.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Singulair Paediatric can cause side effects, although not everybody gets them.
In clinical studies with Singulair Paediatric, 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 10mg 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 (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, sleepwalking, 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 (Veryrare)]
• 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.
Reporting of side effects
If you or 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
By reporting side effects, you can help provide more information on the safety of this medicine
5. HOW TO STORE SINGULAIR PAEDIATRIC
• Keep Singulair out of the sight and reach of children.
• Do not store tablets above 30°C.
• Store in the original pack to protect from light and moisture.
• Do not put the tablets into another container, as they might get mixed up. Do not remove the tablet from the calendar pack until your child is ready to take it.
• Do not give the tablets to your child if they have passed the expiry date, which is clearly marked on the pack.
• If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
• If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal.
• Only keep this medicine, if your doctor tells you to. REMEMBER: This medicine is for your child only. It should not be shared with anyone else.
• 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 Paediatric contains
• The active ingredient in SINGULAIR Paediatric is montelukast sodium. SINGULAIR Paediatric contains montelukast sodium equivalent to 5mg montelukast.
• 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 Paediatric looks like and contents of the pack
Each Paediatric tablet is pink, round, biconvex, debossed with '275' on one side and plain on the other side.
Pack size: 28 tablets.
Manufactured by:- Doppel Farmaceutici Srl Via Volturno, 48 Quinto de Stampi, 20089 Rozzano, Milan, Italy.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
SINGULAIR® Paediatric 5mg Chewable Tablets;
PL 18799/0963
Leaflet date: 09.11.2015 POM
Singulair is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.
PACKAGE LEAFLET: INFORMATION FOR THE USER MONTELUKAST Paediatric 5mg Chewable Tablets
(montelukast sodium)
Read all of this leaflet carefully before you or your child
start taking this medicine.
• 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 you or your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours or your child’s.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is MONTELUKAST Paediatric 5mg
Chewable Tablets but it will be referred to as Montelukast or
Montelukast Paediatric throughout this leaflet.
In this leaflet:
1. What Montelukast Paediatric is and what it is used for
2. Before you take Montelukast Paediatric
3. How to take Montelukast Paediatric
4. Possible side effects
5. How to store Montelukast Paediatric
6. Further information
1. WHAT MONTELUKAST PAEDIATRIC IS AND WHAT IT IS USED FOR
Montelukast Paediatric is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs.
By blocking leukotrienes, Montelukast Paediatric improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast Paediatric to treat asthma, preventing your asthma symptoms during the day and night.
• Montelukast Paediatric is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast 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.
• Montelukast Paediatric also helps prevent the narrowing of airways triggered by exercise.
Your doctor will determine how Montelukast Paediatric should be used depending on the symptoms and severity of you 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. BEFORE YOU TAKE MONTELUKAST PAEDIATRIC
Tell your doctor about any medical problems or allergies you or
your child has now or has had.
Do not take Montelukast Paediatric if you or your child
• is allergic (hypersensitive) to montelukast or any of the other ingredients of Montelukast Paediatric (see 6. 'Further information').
Take special care with Montelukast Paediatric
• If you or your child's asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast 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. Montelukast 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 anti-inflammatory medicines (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
Use in children
For children 2 to 5 years old, Montelukast Paediatric 4mg chewable tablets and Montelukast Paediatric 4mg granules are available.
For children 6 to 14 years old, Montelukast Paediatric 5mg chewable tablets are available.
Taking other medicines
Some medicines may affect how Montelukast Paediatric works, or Montelukast Paediatric may affect how other medicines work.
Please tell your doctor or pharmacist if you or your child is taking or has recently taken other medicines, including those obtained without a prescription.
Tell your doctor if you or your child is taking the following medicines before starting Montelukast Paediatric:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Taking Montelukast Paediatric with food and drink
Montelukast Paediatric 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
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 Paediatric
Montelukast Paediatric 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 Paediatric contains phenylalanine (equivalent to 0.842mg phenylalanine per 5mg chewable tablet).
3. HOW TO TAKE MONTELUKAST PAEDIATRIC
• You or your child should take only one tablet of Montelukast 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.
• Always take Montelukast Paediatric as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• To be taken by mouth.
For children 6 to 14 years of age:
One Montelukast Paediatric daily to be taken in the evening. Montelukast Paediatric should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
The tablets are to be chewed before swallowing.
If you or your child is taking Montelukast Paediatric, be sure that you or your child does not take any other products that contain the same active ingredient, montelukast.
If you or your child takes more Montelukast 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 Montelukast Paediatric or give Montelukast Paediatric to your child
Try to take Montelukast Paediatric as prescribed. However, if you or your child misses a dose, just resume the usual schedule of one tablet once daily.
Do not take a double dose to make up for a forgotten dose.
If you or your child stops taking Montelukast Paediatric
Montelukast Paediatric 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 Paediatric 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Montelukast Paediatric can cause side effects, although not everybody gets them.
In clinical studies with Montelukast Paediatric, 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 Paediatric were:
• headache
Additionally, the following side effect was reported in clinical studies with Montelukast 10mg film-coated tablets:
• abdominal pain
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)
• behaviour and mood related changes [dream abnormalities, including nightmares, trouble sleeping, sleepwalking, 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 (Veryrare)]
• 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.
Reporting of side effects
If you or 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
By reporting side effects, you can help provide more information on the safety of this medicine
5. HOW TO STORE MONTELUKAST PAEDIATRIC
• Keep Montelukast out of the sight and reach of children.
• Do not store tablets above 30°C.
• Store in the original pack to protect from light and moisture.
• Do not put the tablets into another container, as they might get mixed up. Do not remove the tablet from the calendar pack until your child is ready to take it.
• Do not give the tablets to your child if they have passed the expiry date, which is clearly marked on the pack.
• If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
• If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal.
• Only keep this medicine, if your doctor tells you to. REMEMBER: This medicine is for your child only. It should not be shared with anyone else.
• 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 Paediatric contains
• The active ingredient in MONTELUKAST Paediatric is montelukast sodium. MONTELUKAST Paediatric contains montelukast sodium equivalent to 5mg montelukast.
• 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 Paediatric looks like and contents of the
pack
Each Paediatric tablet is pink, round, biconvex, debossed with
'275' on one side and plain on the other side.
Pack size: 28 tablets.
Manufactured by:- Doppel Farmaceutici Srl Via Volturno, 48
Quinto de Stampi, 20089 Rozzano, Milan, Italy.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
MONTELUKAST Paediatric 5mg Chewable Tablets;
PL 18799/0963
POM
Leaflet date: 09.11.2015 P