SINGULAIR 10 MG FILM COATED TABLETS

Active substance: MONTELUKAST SODIUM

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501035/PL1c

Singulair® 10 mg Film Coated Tablets
(montelukast sodium)
Package Leaflet: Information for the User

The name of your medication is Singulair® 10 mg Film Coated
Tablets. Throughout this leaflet, it will be referred to as
Singulair®.
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 gets 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 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 and also cause allergy
®
symptoms. By blocking leukotrienes, Singulair improves
asthma symptoms, helps control asthma and improves
seasonal allergy symptoms (also known as hay fever or
seasonal allergic rhinitis).
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® also helps prevent the narrowing of airways
triggered by exercise.
• In those asthmatic patients in whom Singulair® is
®
indicated in asthma, Singulair can also provide
symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Singulair® 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®
Tell your doctor about any medical problems or allergies you
have now or have had.
Do not take Singulair® if you
• are allergic (hypersensitive) to montelukast or any of
the other ingredients of Singulair® (see 6. Further
information).
Take special care with Singulair®
• If your 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. 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 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 nonsteroidal anti-inflammatory drugs or NSAIDs) if they
make your asthma worse.

Use in children
For children 2 to 5 years old, Singulair® Paediatric 4 mg
®
chewable tablets and Singulair Paediatric 4 mg granules are
available.
®
For children 6 to 14 years old, Singulair Paediatric 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 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®:
• 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 with food and drink
Singulair® 10 mg 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 . Your
®
doctor will assess whether you can take Singulair during this
time.
Use in breast-feeding
It is not known if Singulair® appears in breast milk. You should
®
consult your doctor before taking Singulair if you are breastfeeding or intend to breast-feed.
Driving and using machines
Singulair® is not expected to affect your ability to drive a car or
operate machinery. However, individual responses to
medication may vary. Certain side effects (such as dizziness
and drowsiness) that have been reported very rarely with
®
Singulair may affect some patients’ ability to drive or operate
machinery.
Important information about some of the ingredients of
Singulair®
Singulair® 10 mg film-coated 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 SINGULAIR®
• You should take only one tablet of Singulair® 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® 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 15 years of age and older:
®
One 10 mg tablet to be taken daily in the evening. Singulair
10 mg may be taken with or without food.
®
If you are taking Singulair , be sure that you do not take any
other products that contain the same active ingredient,
montelukast.
®
If you take 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
Try to take Singulair® 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.
®

If you stop taking Singulair
Singulair® can treat your asthma only if you continue to take it.
®
It is important to continue taking Singulair 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® can cause side effects, although
not everybody gets them.
®
In clinical studies with Singulair 10 mg film-coated 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® were:
• abdominal pain
• headache

These were usually mild and occurred at a greater frequency
in patients treated with Singulair® than with a placebo (a pill
containing no medication).
continued overleaf

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 (Rare); hallucinations, disorientation, suicidal
thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness,
seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• 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); tiredness, feeling unwell, swelling
(Uncommon)

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, 1517 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 Ginova Ltd or Ginova UK Ltd.)

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.
Ask your doctor or pharmacist for more information about side
effects. 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.
5) HOW TO STORE SINGULAIR®
• Keep out of the sight and reach of children.
• Do not use this medicine after the date shown by the
six numbers following EXP on the blister. The first two
numbers indicate the month; the last four numbers
indicate the year. This medicine expires at the end of
the month shown.
• Do not store above 30°C.
• Store in the original package.
• 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 you notice any sign of discolouration or deterioration
of the tablets consult your pharmacist.
6) FURTHER INFORMATION
®
What Singulair contains

• Each film coated tablet contains 10 mg of montelukast
(as montelukast sodium).

• The other ingredients are:
Microcrystalline cellulose, lactose monohydrate,
croscarmellose
sodium,
hydroxypropylcellose,
magnesium stearate, hypromellose, titanium dioxide
(E171), red ferric oxide (E172), yellow ferric oxide
(E172) and carnauba wax.
®

What Singulair looks like and contents of the pack
Singulair® is supplied as beige, rounded square, film coated
tablets with ‘SINGULAIR’ engraved on one side, and ‘MSD
117’ on the other side.
Pack size: 28 tablets in blister packs.
Product Licence Holder and Manufacturer
Manufactured by Merck Sharp & Dohme Limited, Shotton
Lane, Cramlington, Northumberland NE23 3JU, UK.
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent DA11 0HJ.
Singulair® 10 mg Film Coated Tablets
PL No: 18067/0334

POM

Singulair® is a registered trademark of Merck & Co. Inc.
th
Date of revision: 11 June 2013.

501035/PL1c

501037/PL1c

Montelukast 10 mg Film Coated Tablets
(montelukast sodium)
Package Leaflet: Information for the User
The name of your medication is Montelukast 10 mg Film
Coated Tablets. Throughout this leaflet, it will be referred to
as Montelukast.
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 gets 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 is and what it is used for
2) Before you take Montelukast
3) How to take Montelukast
4) Possible side effects
5) How to store Montelukast
6) Further information
1) WHAT MONTELUKAST IS AND WHAT IT IS USED FOR
Montelukast is a leukotriene receptor antagonist that blocks
substances called leukotrienes. Leukotrienes cause narrowing
and swelling of airways in the lungs and also cause allergy
symptoms. By blocking leukotrienes, Montelukast improves
asthma symptoms, helps control asthma and improves
seasonal allergy symptoms (also known as hay fever or
seasonal allergic rhinitis).
Your doctor has prescribed Montelukast to treat asthma,
preventing your asthma symptoms during the day and night.
• Montelukast is used for the treatment of patients who
are not adequately controlled on their medication and
need additional therapy.
• Montelukast also helps prevent the narrowing of
airways triggered by exercise.
• In those asthmatic patients in whom Montelukast is
indicated in asthma, Montelukast can also provide
symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelukast 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.

Use in children
For children 2 to 5 years old, Montelukast Paediatric 4 mg
chewable tablets and Montelukast Paediatric 4 mg granules
are available.
For children 6 to 14 years old, Montelukast Paediatric 5 mg
chewable tablets are available.
Taking other medicines
Some medicines may affect how Montelukast works, or
Montelukast 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:
• 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 with food and drink
Montelukast 10 mg 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. Your
doctor will assess whether you can take Montelukast during
this time.
Use in breast-feeding
It is not known if Montelukast appears in breast milk. You
should consult your doctor before taking Montelukast if you
are breast-feeding or intend to breast-feed.
Driving and using machines
Montelukast is not expected to affect your ability to drive a car
or operate machinery. However, individual responses to
medication may vary. Certain side effects (such as dizziness
and drowsiness) that have been reported very rarely with
Montelukast may affect some patients’ ability to drive or
operate machinery.
Important information about some of the ingredients of
Montelukast
Montelukast 10 mg film-coated 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
• You should take only one tablet of Montelukast 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 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 15 years of age and older:
One 10 mg tablet to be taken daily in the evening.
Montelukast 10 mg may be taken with or without food.
If you are taking Montelukast, be sure that you do not take
any other products that contain the same active ingredient,
montelukast.
If you take more Montelukast than you should
Contact your doctor immediately for advice.

2) BEFORE YOU TAKE MONTELUKAST
Tell your doctor about any medical problems or allergies you
have now or have had.

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.

Do not take Montelukast if you
• are allergic (hypersensitive) to montelukast or any of
the other ingredients of Montelukast (see 6. Further
information).

If you forget to take Montelukast
Try to take Montelukast as prescribed. However, if you miss a
dose, just resume the usual schedule of one tablet once daily.

Take special care with Montelukast
• If your asthma or breathing gets worse, tell your doctor
immediately.
• Oral Montelukast is 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
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 nonsteroidal anti-inflammatory drugs or NSAIDs) if they
make your asthma worse.

Do not take a double dose to make up for a forgotten dose.
If you stop taking Montelukast
Montelukast can treat your asthma only if you continue to take
it.
It is important to continue taking Montelukast 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 can cause side effects,
although not everybody gets them.
In clinical studies with Montelukast 10 mg film-coated 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 were:
• abdominal pain
• headache
These were usually mild and occurred at a greater frequency
in patients treated with Montelukast than with a placebo (a pill
containing no medication).
continued overleaf

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 (Rare); hallucinations, disorientation, suicidal
thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness,
seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• 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); tiredness, feeling unwell, swelling
(Uncommon)

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, 1517 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 Ginova Ltd or Ginova UK Ltd.)

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.
Ask your doctor or pharmacist for more information about side
effects. 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.
5) HOW TO STORE MONTELUKAST
• Keep out of the sight and reach of children.
• Do not use this medicine after the date shown by the
six numbers following EXP on the blister. The first two
numbers indicate the month; the last four numbers
indicate the year. This medicine expires at the end of
the month shown.
• Do not store above 30°C.
• Store in the original package.
• 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 you notice any sign of discolouration or deterioration
of the tablets consult your pharmacist.
6) FURTHER INFORMATION
What Montelukast contains

• Each film coated tablet contains 10 mg of montelukast
(as montelukast sodium).

• The other ingredients are:
Microcrystalline cellulose, lactose monohydrate,
croscarmellose
sodium,
hydroxypropylcellose,
magnesium stearate, hypromellose, titanium dioxide
(E171), red ferric oxide (E172), yellow ferric oxide
(E172) and carnauba wax.
What Montelukast looks like and contents of the pack
Montelukast is supplied as beige, rounded square, film coated
tablets with ‘SINGULAIR’ engraved on one side, and ‘MSD
117’ on the other side.
Pack size: 28 tablets in blister packs.
Product Licence Holder and Manufacturer
Manufactured by Merck Sharp & Dohme Limited, Shotton
Lane, Cramlington, Northumberland NE23 3JU, UK.
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent DA11 0HJ.
Montelukast 10 mg Film Coated Tablets
PL No: 18067/0334

POM

th
Date of revision: 11 June 2013.

501037/PL1c

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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