Singulair Paediatric 4mg Chewable Tablets
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.
S1687 LEAFLET Singulair 20150302
PACKAGE LEAFLET: INFORMATION FOR THE USER SINGULAIR® PAEDIATRIC 4mg CHEWABLE TABLETS (montelukast sodium)
Your medicine is known as Singulair Paediatric 4mg Chewable Tablets but will be referred to as Singulair throughout the following leaflet.
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.
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.
• 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 a nti-inflammatory medicines (also known as non-steroidal antiinflammatory 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 should not be taken immediately with food; it 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 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 breast-feed.
Driving and using machines
This subsection is not applicable for the Singulair since it is 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
Singulair 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 contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
3. HOW TO TAKE SINGULAIR
• 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
For children 2 to 5 years of age:
One Singulair 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. The tablets are to be chewed before swallowing.
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 4 mg chewable tablets and 4 mg granules are available.
For children 6 to 14 years old, Singulair 5 mg chewable tablets are available. The Singulair 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 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, 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
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Store in the original package in order to protect from light and moisture.
• Do not take this medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of that month.
• 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. FURTHER INFORMATION
What Singulair contains
• Each chewable tablet contains montelukast sodium which is equivalent to 4mg of 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
• Tablets are pink, oval, biconvex with SINGULAIR engraved on one side and MSD 711 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 No: 19488/1687
Leaflet revision date: 02 March 2015
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.)
S1687 LEAFLET Singulair 20150302
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.
S1687 LEAFLET Montelukast 20150302
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST PAEDIATRIC 4mg CHEWABLE TABLETS
(montelukast sodium)
Your medicine is known as Montelukast Paediatric 4mg Chewable Tablets but will be referred to as Montelukast Tablets throughout the following leaflet.
In this leaflet:
1. What Montelukast Tablets are and what they are used for
2. Before Montelukast Tablets are taken
3. How to take Montelukast Tablets
4. Possible side effects
5. How to store Montelukast Tablets
6. Further information
1. WHAT MONTELUKAST TABLETS ARE AND WHAT THEY ARE USED FOR
Montelukast Tablets are a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast Tablets improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast Tablets to treat your child's asthma, preventing asthma symptoms during the day and night.
• Montelukast Tablets are used for the treatment of 2 to 5 year old patients 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 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 Tablets also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
Your doctor will determine how Montelukast Tablets 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 TABLETS ARE TAKEN
Tell your doctor about any medical problems or allergies your child
has now or has had.
Do not give Montelukast Tablets to your child if he/she
• is allergic (hypersensitive) to montelukast or any of the other ingredients of Montelukast Tablets (see 6. Further information).
Take special care with Montelukast Tablets
• If 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 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 Tablets 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 a nti-inflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make his/her asthma worse.
Taking other medicines
Some medicines may affect how Montelukast Tablets works, or Montelukast Tablets 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 Tablets:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections) Taking Montelukast Tablets with food and drink
Montelukast 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 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 Tablets. Your doctor will assess whether you can take Montelukast Tablets during this time.
Use in 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
This subsection is not applicable for the Montelukast 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.
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 very rarely with Montelukast Tablets may affect some patients' ability to drive or operate machinery.
Important information about some of the ingredients of Montelukast Tablets
Montelukast 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 Tablets contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
3. HOW TO TAKE MONTELUKAST TABLETS
• 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 Tablets 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 Tablets 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
For children 2 to 5 years of age:
One Montelukast Tablets daily to be taken in the evening.
Montelukast Tablets 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 Tablets, 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 Tablets 4 mg chewable tablets and 4 mg granules are available.
For children 6 to 14 years old, Montelukast Tablets 5 mg chewable tablets are available. The Montelukast Tablets 4 mg chewable tablet is not recommended below 2 years of age.
If your child takes more Montelukast Tablets 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 Tablets to your child
Try to give Montelukast Tablets 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 Tablets
Montelukast Tablets can treat your child's asthma only if he/she continues taking it.
It is important for your child to continue taking Montelukast Tablets 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 Tablets can cause side effects, although not everybody gets them.
In clinical studies with Montelukast 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:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies with Montelukast Tablets 10 mg film-coated tablets and 5 mg chewable tablets:
• headache
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 (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 TABLETS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Store in the original package in order to protect from light and moisture.
• Do not take this medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of that month.
• 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. FURTHER INFORMATION
What Montelukast Tablets contains
• Each chewable tablet contains montelukast sodium which is equivalent to 4mg of 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 looks like and contents of the pack
• Tablets are pink, oval, biconvex with Montelukast Tablets engraved on one side and MSD 711 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 No: 19488/1687 Leaflet revision date: 02 March 2015
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.)
S1687 LEAFLET Montelukast 20150302