Singulair Paediatric 4mg Chewable Tablets
PACKAGE LEAFLET: INFORMATION FOR THE
USER
Singulair® Paediatric 4mg chewable tablets
(montelukast sodium)
Read all of this leaflet carefully before your child starts 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 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.
The name of your medicine is Singulair Paediatric 4mg 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 Singulair Paediatric is taken
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 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.
2. BEFORE SINGULAIR PAEDIATRIC IS TAKEN
Tell your doctor about any medical problems or allergies your
child has now or has had.
Do not give Singulair Paediatric to your child if he/she
• 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 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 flulike 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.
Taking other medicines
Some medicines may affect how Singulair Paediatric works, or Singulair Paediatric 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 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; 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 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 breastfeeding or intend to breast-feed.
Driving and using machines
This subsection is not applicable for the Singulair Paediatric 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 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 chewable tablets contain 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 0.674mg phenylalanine per 4mg chewable tablet).
3. HOW TO TAKE SINGULAIR PAEDIATRIC
• 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 Paediatric 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 Paediatric 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
A translation of the day of the week as they appear on the blister strips is as follows:
Italian: Lunedi Martedi Mercoledi Giovedi Venerdi Sabato Domenica
English: Mon Tues Wed Thur Fri Sat Sun
For children 2 to 5 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 your child is taking Singulair Paediatric, 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 4mg chewable tablets and 4mg granules are available.
For children 6 to 14 years old, Singulair Paediatric 5mg chewable tablets are available. The Singulair Paediatric is not recommended below 2 years of age.
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 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.
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 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:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies with Singulair 10mg film-coated tablets and 5mg 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, 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
(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 your child gets one or more of these symptoms.
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 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 take your tablets after the expiry date which is stated on the carton and blister label after ‘Exp'. The expiry date refers to the last day of that month.
Store in the original package 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 signs of deterioration, seek the advice of your pharmacist.
6. FURTHER INFORMATION
What Singulair Paediatric contains
• The active ingredient in Singulair Paediatric is montelukast sodium. Each chewable tablet contains montelukast sodium equivalent to 4mg montelukast.
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, red ferric oxide (E172) croscarmellose sodium, cherry flavour, aspartame (E951) and magnesium stearate.
What Singulair Paediatric looks like and contents of the pack
The tablets are pink, oval, bi-convex shaped engraved 'MSD 711' on one side and ‘Singulair' on the other.
Singulair Paediatric is available in blister packs containing 28 tablets.
Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN, Haarlem, Holland.
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 4mg chewable tablets;
PL No: 18799/2117
POM
Leaflet date: 25.06.2015 M
Singulair is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.
Montelukast Paediatric 4mg chewable tablets
(montelukast sodium)
Read all of this leaflet carefully before your child starts 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 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.
The name of your medicine is Montelukast Paediatric 4mg chewable tablets but it will be referred to as Montelukast or Montelukast Paediatric throughout this leaflet.
In this leaflet:
1. What Montelukast Paediatric and what it is used for
2. Before Montelukast Paediatric taken
3. How to take Montelukast Paediatric
4. Possible side effects
5. How to store Montelukast Paediatric
6. Further information
1. WHAT MONTELUKAST PAEDIATRIC AND WHAT IT IS USED FOR
Montelukast Paediatric 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 your child's asthma, preventing asthma symptoms during the day and night.
• Montelukast Paediatric used for the treatment of 2 to 5 year old 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 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 Paediatric also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
Your doctor will determine how Montelukast 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.
2. BEFORE MONTELUKAST PAEDIATRIC TAKEN
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Montelukast Paediatric to your child if he/she
• 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 your child's asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast Paediatric 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 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 flulike 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.
Taking other medicines
Some medicines may affect how Montelukast Paediatric works, or Montelukast Paediatric 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 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; 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 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 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
This subsection is not applicable for the Montelukast Paediatric 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.
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 chewable tablets contain 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 0.674mg phenylalanine per 4mg chewable tablet).
3. HOW TO TAKE MONTELUKAST PAEDIATRIC
• 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 Paediatric 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 Paediatric 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
A translation of the day of the week as they appear on the blister strips is as follows:
Italian: Lunedi Martedi Mercoledi Giovedi Venerdi Sabato Domenica
English: Mon Tues Wed Thur Fri Sat Sun
For children 2 to 5 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 your child is taking Montelukast Paediatric, 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 Paediatric4mg chewable tablets and 4mg granules are available.
For children 6 to 14 years old, Montelukast Paediatric5mg chewable tablets are available. The Montelukast Paediatric not recommended below 2 years of age.
If your child takes more Montelukast 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 Montelukast Paediatric to your child
Try to give Montelukast Paediatric 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 Paediatric
Montelukast Paediatric can treat your child's asthma only if he/she continues taking it.
It is important for your child to continue taking Montelukast Paediatric 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, 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:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies with Montelukast 10mg film-coated tablets and 5mg 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)
• 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
(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 your child gets one or more of these symptoms.
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 By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE MONTELUKAST PAEDIATRIC
Keep out of the sight and reach of children.
Do not take your tablets after the expiry date which is stated on the carton and blister label after ‘Exp'. The expiry date refers to the last day of that month.
Store in the original package 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 signs of deterioration, seek the advice of your pharmacist.
6. FURTHER INFORMATION
What Singulair Paediatric contains
• The active ingredient in Singulair Paediatric is montelukast sodium. Each chewable tablet contains montelukast sodium equivalent to 4mg montelukast.
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, red ferric oxide (E172) croscarmellose sodium, cherry flavour, aspartame (E951) and magnesium stearate.
What Singulair Paediatric looks like and contents of the pack
The tablets are pink, oval, bi-convex shaped engraved 'MSD 711' on one side and ‘Singulair' on the other.
Singulair Paediatric is available in blister packs containing 28 tablets.
Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN, Haarlem, Holland.
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 4mg chewable tablets;
PL No: 18799/2117
POM
Leaflet date: 25.06.2015 1