Singulair 10mg Tablets
Rev. date: 08.01.2015
Leaflet reference: SING10/UT
PACKAGE LEAFLET: INFORMATION FOR THE USER SINGULAIR® 10mg TABLETS (montelukast sodium)
Read all of this leaflet carefully before you 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Singulair® 10mg Tablets are and what are they used for
2. Before you take Singulair® 10mg Tablets
3. How to take Singulair® 10mg Tablets
4. Possible side effects
5. How to store Singulair® 10mg Tablets
6. Further information
1. WHAT SINGULAIR® 10MG TABLETS ARE AND WHAT ARE THEY USED FOR
Singulair® 10mg Tablets are leukotriene receptor antagonists that block substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Singulair® 10mg Tablets improve asthma symptoms, help control asthma and improve seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Singulair® 10mg T ablets to treat asthma, preventing your asthma symptoms during the day and night.
• Singulair® 10mg T ablets are used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
• Singulair® 10mg Tablets also help prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom Singulair® 10mg Tablets is indicated in asthma, Singulair® 10mg Tablets can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Singulair® 10mg Tablets should be used depending on the symptoms and severity of your 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. What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollens from trees, grasses and weeds. The symptoms of seasonal allergies typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.
2. BEFORE YOU TAKE SINGULAIR® 10MG TABLETS
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Singulair® 10mg Tablets if you
• are allergic (hypersensitive) to montelukast or any of the other ingredients of Singulair® 10mg Tablets (see 6. Further information).
Take special care with Singulair® 10mg Tablets
• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral Singulair® 10mg Tablets are not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you. 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® 10mg Tablets should not be substituted for other asthma medications your doctor has prescribed for you.
• Any patient on anti-asthma medicines should be aware that if you develop a combination of symptoms such as a 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 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® 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® 10mg Tablets work, or Singulair® 10mg Tablets may affect how other medicines work.
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including those obtained without a prescription.
Tell your doctor if you are taking the following medicines before starting Singulair® 10mg Tablets:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used for treatment of high lipid levels in plasma).
Taking Singulair® 10mg Tablets with food and drink
Singulair® 10mg T ablets may be taken with or without food.
Pregnancy and breast-feeding
Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking Singulair® 10mg Tablets. Your doctor will assess whether you can take Singulair® 10mg Tablets during this time. Use in breast-feeding
It is not known if Singulair® 10mg Tablets appear in breast milk. You should consult your doctor before taking Singulair® 10mg Tablets if you are breast-feeding or intend to breast-feed.
Driving and using machines
Singulair® 10mg 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 Singulair® 10mg Tablets may affect some patients' ability to drive or operate machinery.
Important information about some of the ingredients of Singulair® 10mg Tablets
Singulair® 10mg T ablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE SINGULAIR® 10MG TABLETS
• You should take only one tablet of Singulair® 10mg Tablets once a day as prescribed by your doctor.
• It should be taken even when you have no symptoms or have an acute asthma attack.
• Always take Singulair® 10mg 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 adults and adolescents 15 years of age and older:
One 10mg tablet to be taken daily in the evening. Singulair® 10mg Tablets may be taken with or without food.
If you are taking Singulair® 10mg T ablets, be sure that you do not take any other products that contain the same active ingredient, montelukast.
A translation of the days of the week on the blister strip is as follows:
LUN MAR MIE JUE VIE SAB DOM
MON TUE WED THU FRI SAT SUN
If you take more Singulair® 10mg 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 Singulair® 10mg Tablets
Try to take Singulair® 10mg Tablets as prescribed. However, if you miss 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.
Singulair® 10mg T ablets can treat your asthma only if you continue to take it.
It is important to continue taking Singulair® 10mg Tablets for as long as your doctor prescribes. It will help control your 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® 10mg Tablets can cause side effects, although not everybody gets them.
In clinical studies with Singulair® 10mg Tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 patients treated) thought to be related to Singulair® 10mg T ablets were:
• abdominal pain
• headache
These were usually mild and occurred at a greater frequency in patients treated with Singulair® 10mg 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, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression (Uncommon); tremor, disturbance in attention, memory impairment (Rare); hallucinations, disorientation, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon), swelling (inflammation) of the lungs (Very rare)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• rash (Common); bruising, itching, hives (Uncommon); tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); weakness/tiredness, feeling unwell, swelling (Uncommon)
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported. You must tell your doctor right away if you get one or more of these symptoms.
Reporting of side effects:
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: 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® 10MG TABLETS
• Do not store above 30°C. Store in the original package to protect from moisture and light.
• Do not put the tablets into another container, as they might get mixed up. Do not remove the tablet from the calendar pack until you or your child is ready to take it.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on the carton label.
• If your doctor stops treatment return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Singulair® 10mg Tablets contains
Each film-coated tablet contains 10mg of the active ingredient montelukast (as sodium).
Each tablet also contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E171), red ferric oxide (E172), yellow ferric oxide (E172) and carnauba wax.
What Singulair® 10mg Tablets looks like and the contents of the pack
Singulair® 10mg Tablets are rounded square, beige, film-coated tablets marked ‘SINGULAIR' on one side ‘MSD 117' on the reverse.
Singulair® 10mg Tablets are available as calendar blister packs of 28 tablets.
Who manufactured your medicine
Manufactured by Merck Sharp & Dohme B.V., Waarderweg 39, 2031 PC Haarlem, Holland. Procured from within the EU and repackaged by Product Licence Holder Beachcourse Limited., 20 Alliance Court, Alliance Road, London W3 0RB.
PL16378/0373 |POM|
Revision date: 08.01.2015 Leaflet reference: SING10/UT
Singulair® is a registered trademark of Merck & Co., Inc.
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 1 pm, 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 or Beachcourse Limited).
PACKAGE LEAFLET: INFORMATION FOR THE USER MONTELUKAST 10MG TABLETS (montelukast sodium)
Read all of this leaflet carefully before you 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Montelukast 10mg Tablets are and what are they used for
2. Before you take Montelukast 10mg Tablets
3. How to take Montelukast 10mg Tablets
4. Possible side effects
5. How to store Montelukast 10mg Tablets
6. Further information
1. WHAT MONTELUKAST 10MG TABLETS ARE AND WHAT ARE THEY USED FOR
Montelukast 10mg Tablets are leukotriene receptor antagonists that block substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast 10mg Tablets improve asthma symptoms, help control asthma and improve seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast 10mg Tablets to treat asthma, preventing your asthma symptoms during the day and night.
• Montelukast 10mg Tablets are used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast 10mg Tablets also help prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom Montelukast 10mg Tablets is indicated in asthma, Montelukast 10mg Tablets can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelukast 10mg Tablets should be used depending on the symptoms and severity of your 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. What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollens from trees, grasses and weeds. The symptoms of seasonal allergies typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.
2. BEFORE YOU TAKE MONTELUKAST 10MG TABLETS
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Montelukast 10mg Tablets if you
• are allergic (hypersensitive) to montelukast or any of the other ingredients of Montelukast 10mg Tablets (see 6. Further information).
Take special care with Montelukast 10mg Tablets
• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast 10mg Tablets are not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you. 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 10mg Tablets should not be substituted for other asthma medications your doctor has prescribed for you.
• Any patient on anti-asthma medicines should be aware that if you develop a combination of symptoms such as a 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 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 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 10mg Tablets work, or Montelukast 10mg Tablets may affect how other medicines work.
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including those obtained without a prescription.
Tell your doctor if you are taking the following medicines before starting Montelukast 10mg Tablets:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used for treatment of high lipid levels in plasma).
Taking Montelukast 10mg Tablets with food and drink
Montelukast 10mg Tablets may be taken with or without food.
Pregnancy and breast-feeding
Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast 10mg Tablets. Your doctor will assess whether you can take Montelukast 10mg Tablets during this time. Use in breast-feeding
It is not known if Montelukast 10mg Tablets appear in breast milk. You should consult your doctor before taking Montelukast 10mg Tablets if you are breast-feeding or intend to breast-feed.
Driving and using machines
Montelukast 10mg 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 10mg Tablets may affect some patients' ability to drive or operate machinery.
Important information about some of the ingredients of Montelukast 10mg Tablets
Montelukast 10mg Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE MONTELUKAST 10MG TABLETS
• You should take only one tablet of Montelukast 10mg Tablets once a day as prescribed by your doctor.
• It should be taken even when you have no symptoms or have an acute asthma attack.
• Always take Montelukast 10mg 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 adults and adolescents 15 years of age and older:
One 10mg tablet to be taken daily in the evening. Montelukast 10mg Tablets may be taken with or without food.
If you are taking Montelukast 10mg Tablets, be sure that you do not take any other products that contain the same active ingredient, montelukast.
A translation of the days of the week on the blister strip is as follows:
LUN MAR MIE JUE VIE SAB DOM
MON TUE WED THU FRI SAT SUN
If you take more Montelukast 10mg 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 10mg Tablets
Try to take Montelukast 10mg Tablets as prescribed. However, if you miss 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.
Montelukast 10mg Tablets can treat your asthma only if you continue to take it.
It is important to continue taking Montelukast 10mg Tablets for as long as your doctor prescribes. It will help control your 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 10mg Tablets can cause side effects, although not everybody gets them.
In clinical studies with Montelukast 10mg Tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 patients treated) thought to be related to Montelukast 10mg Tablets were:
• abdominal pain
• headache
These were usually mild and occurred at a greater frequency in patients treated with Montelukast 10mg 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, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression (Uncommon); tremor, disturbance in attention, memory impairment (Rare); hallucinations, disorientation, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon), swelling (inflammation) of the lungs (Very rare)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• rash (Common); bruising, itching, hives (Uncommon); tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); weakness/tiredness, feeling unwell, swelling (Uncommon)
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported. You must tell your doctor right away if you get one or more of these symptoms.
Reporting of side effects:
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: 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 10MG TABLETS
• Do not store above 30°C. Store in the original package to protect from moisture and light.
• Do not put the tablets into another container, as they might get mixed up. Do not remove the tablet from the calendar pack until you or your child is ready to take it.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on the carton label.
• If your doctor stops treatment return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Montelukast 10mg Tablets contains
Each film-coated tablet contains 10mg of the active ingredient montelukast (as sodium).
Each tablet also contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E171), red ferric oxide (E172), yellow ferric oxide (E172) and carnauba wax.
What Montelukast 10mg Tablets looks like and the contents of the pack
Montelukast 10mg Tablets are rounded square, beige, film-coated tablets marked ‘MONTELUKAST' on one side ‘mSd 117' on the reverse.
Montelukast 10mg Tablets are available as calendar blister packs of 28 tablets.
Who manufactured your medicine
Manufactured by Merck Sharp & Dohme B.V., Waarderweg 39, 2031 PC Haarlem, Holland. Procured from within the EU and repackaged by Product Licence Holder Beachcourse Limited., 20 Alliance Court, Alliance Road, London W3 0RB.
PL16378/0373 |POM|
Revision date: 08.01.2015 Leaflet reference: MONT10/UT
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 1 pm, 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 or Beachcourse Limited).