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Singulair® 10mg Tablets /
Montelukast 10mg Tablets
(montelukast sodium)
This medicine is known by the above names but will be referred to as
Singulair throughout this leaflet.
Package leaflet: Information for the user
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
• 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
• 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

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 4 mg granules are available.
For children 6 to 14 years old, Singulair Paediatric 5mg chewable tablets are
Taking other medicines
Some medicines may affect how Singulair works, or Singulair may affect how
other medicines work.

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

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
• 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 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).

Singulair 10mg may be taken with or without food.

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
• In those asthmatic patients in whom Singulair is indicated in asthma,
Singulair can also provide symptomatic relief of seasonal allergic rhinitis.

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 breastfeed.
Driving and using machines

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.

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
Important information about some of the ingredients of Singulair
Singulair contains 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.

Symptoms of asthma include: Coughing, wheezing, and chest tightness.

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.

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:

Tell your doctor about any medical problems or allergies you have now or
have had.

One 10 mg tablet to be taken daily in the evening. Singulair 10mg may be
taken with or without food.

Do not take Singulair if you

If you are taking Singulair, be sure that you do not take any other products
that contain the same active ingredient, montelukast.

What are seasonal allergies?

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.

The following is a translation of the days of the week on the blister strip.
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

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.

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.

Do not take a double dose to make up for a forgotten dose.
What Singulair contains
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.

Singulair contain the active ingredient montelukast sodium.
Each tablet contains montelukast sodium equivalent to 10mg montelukast.

If you have any further questions on the use of this product, ask your doctor
or pharmacist.

The other ingredients in the tablets are microcrystalline cellulose (E460),
lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose,
magnesium stearate (E572), hypromellose, titanium dioxide (E171), red and
yellow ferric oxide (E172) and carnauba wax.


What Singulair looks like and contents of the pack

Like all medicines, Singulair can cause side effects, although not everybody
gets them.

The tablets are supplied as beige, rounded square, film-coated tablets with
‘SINGULAIR’ engraved on one side and ‘MSD 117’ on the other side.

In clinical studies with Singulair 10mg 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 tablets come in blister packs of 7 and 28 tablets.

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
• 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
• 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
By reporting side effects, you can help provide more information on the
safety of this medicine.
Keep out of the sight and reach of children.
Store in the original package.
Do not store above 30°C, protected 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 are ready to take it.
Do not take the tablets after the expiry date, which is clearly marked on the
pack. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking this medicine, take it back to the
pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration
you should seek the advice of your pharmacist who will tell you what to do.

Singulair are manufactured by Merck Sharp & Dohme Limited, Shotton Lane,
Cramlington, Northumberland NE23 9JU, UK.
Procured from within the EU by the Product Licence holder:
Caseview (PL) Ltd., 20 Alliance Court, Alliance Road, London W3 0RB.
Repackaged by OPD Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts
WD24 4PR.
PL 13826/0326

Singulair® 10mg Tablets /Montelukast 10mg Tablets
Leaflet revision date (ref) 17/02/2015

Singulair is a registered Trade Mark of Merck Sharp & Dohme Corp., New
Jersey, U.S.A.
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.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

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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.