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SINGULAIR 10MG FILM-COATED TABLET

Active substance(s): MONTELUKAST SODIUM

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5. HOW TO STORE SINGULAIR
• Keep out of the reach and sight 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.
• Store in the original package in order to protect
from light and moisture.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

What SINGULAIR contains
• The active substance is montelukast. Each tablet
contains montelukast sodium which corresponds
to 10 mg of montelukast.
• The other ingredients are:
Microcrystalline cellulose, lactose monohydrate
(89.3 mg), croscarmellose sodium, hyprolose
(E 463), and magnesium stearate.
Film coating: hypromellose, hyprolose (E 463),
titanium dioxide (E 171), red and yellow ferric
oxide (E 172), and carnauba wax.
What SINGULAIR looks like and contents of the pack
10 mg SINGULAIR tablets are beige, rounded square,
film-coated with SINGULAIR engraved on one side,
MSD 117 on the other.
Blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 84,
90, 98, 100, 140, and 200 tablets.
Blisters (unit doses) in packages of: 49, 50 and
56 tablets.

montelukast

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.)
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, Belgium, Denmark, Finland, France,
Greece, Spain, Sweden, Germany, Ireland, UK, Italy,
Luxemburg, Netherlands, Portugal
SINGULAIR
This package leaflet was last revised in October 2014
© Merck Sharp & Dohme Limited 2014. All rights
reserved.
PIL.SGA-10mg.13.UK.3914.II-081-WS-16

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.
2.
3.
4.
5.
6.

What SINGULAIR is and what it is used for
Before you take SINGULAIR
How to take SINGULAIR
Possible side effects
How to store SINGULAIR
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.

Not all pack sizes may be marketed.

6558

SINGULAIR® 10 mg
film-coated tablets

The Marketing Authorisation Holder is Merck Sharp
& Dohme Limited, Hertford Road, Hoddesdon,
Hertfordshire EN11 9BU, UK.
SINGULAIR 10 mg tablets are manufactured by Merck
Sharp & Dohme Limited, Shotton Lane, Cramlington,
Northumberland, NE23 3JU, UK.

For Position Only

6. FURTHER INFORMATION

PACKAGE LEAFLET: INFORMATION FOR THE USER

Marketing Authorisation Holder and
Manufacturer

XXXX/XXXXXX-X

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.
XXXX/XXXXXX-X

• 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
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 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

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 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.

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 and adolescents 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
XXXX/XXXXXX-X



If you stop taking SINGULAIR






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
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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly (see details below). By reporting
side effects you can help provide more information
on the safety of this medicine.
United Kingdom: Yellow Card Scheme at: www.
mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1
6762517. Website: www.hpra.ie; E-mail: medsafety@
hpra.ie.
Malta: ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3, Rue D’Argens,
GŻR-1368 Gżira Website: www.medicinesauthority.
gov.mt; e-mail: postlicensing.medicinesauthority@
gov.mt
XXXX/XXXXXX-X

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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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