Singulair Paediatric 5mg Chewable Tablets
Out of date information, search anotherRead all of this leaflet carefully before you or your child starts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 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.
S1688 LEAFLET Singulair 20150303
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.
In this leaflet:
1. What Singulair is and what it is used for
2. Before you take Singulair
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 asthma, preventing your asthma symptoms during the day and night.
• Singulair is used for the treatment of 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 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 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
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 (hypersensitive) to montelukast or any of the other ingredients of Singulair (see 6. Further information).
Take special care with 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.
Use in children
For children 2 to 5 years old, Singulair 4 mg chewable tablets and Singulair 4 mg granules are available.
For children 6 to 14 years old, Singulair 5 mg chewable tablets are available.
Taking other medicines
Some medicines may affect how Singulair works, or Singulair 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:
• 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 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 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 very rarely with
Singulair may affect some patients' ability to drive or operate
machinery.
Important information about some of the ingredients of Singulair
Singulair contains aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each Singulair 5 mg chewable tablet contains phenylalanine (equivalent to 0.842 mg phenylalanine per 5 mg chewable tablet).
3. HOW TO TAKE SINGULAIR
• You or your child should take only one 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.
• Always take Singulair 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 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 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.
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 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 product, ask your 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 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 (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 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
• 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. FURTHER 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 No: 19488/1688
Leaflet revision date: 03 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.)
S1688 LEAFLET Singulair 20150303
Read all of this leaflet carefully before you or 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 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.
S1688 LEAFLET Montelukast 20150303
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.
In this leaflet:
1. What Montelukast Tablets are and what they are used for
2. Before you take Montelukast Tablets
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 asthma, preventing your asthma symptoms during the day and night.
• Montelukast Tablets are used for the treatment of 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 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 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 TABLETS
Tell your doctor about any medical problems or allergies you or your child has now or has had.
Do not take Montelukast T ablets if you or your child
• 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 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.
Use in children
For children 2 to 5 years old, Montelukast Tablets 4 mg chewable
tablets and Montelukast Tablets 4 mg granules are available.
For children 6 to 14 years old, Montelukast Tablets 5 mg chewable
tablets are available.
Taking other medicines
Some medicines may affect how Montelukast Tablets works, or Montelukast Tablets 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 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; 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 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
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 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 Tablets 5 mg chewable tablet contains phenylalanine (equivalent to 0.842 mg phenylalanine per 5 mg chewable tablet).
3. HOW TO TAKE MONTELUKAST TABLETS
• You or your child should take only one 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.
• Always take Montelukast Tablets 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 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 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.
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 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 product, ask your 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 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 (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 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 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. FURTHER 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 looks like and contents of the pack
• Montelukast Tablets is pink, round, biconvex tablets with Montelukast Tablets engraved on one side, MSD 275 on the other.
• Montelukast Tablets 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: 19488/1688 Leaflet revision date: 03 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.)
S1688 LEAFLET Montelukast 20150303