MONTELUKAST SODIUM 10MG TABLETS

Active substance: MONTELUKAST SODIUM

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S534 LEAFLET Singulair 20121218

PACKAGE LEAFLET: INFORMATION FOR THE USER

SINGULAIR 10mg TABLETS
(montelukast sodium)

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

Your medicine is known as Singulair 10mg Tablets but will be
referred to as Singulair throughout the following patient information
leaflet.



are allergic (hypersensitive) to montelukast or any of the other
ingredients of Singulair (see 6. Further information).

Take special care with Singulair
Read all of this leaflet carefully before you start taking this
medicine.



If your asthma or breathing gets worse, tell your doctor
immediately.



Keep this leaflet. You may need to read it again.





If you have any further questions, please ask your doctor or
pharmacist.



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.

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.

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 antiinflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make your asthma
worse.

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.

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:

Singulair also helps prevent the narrowing of airways triggered
by exercise.



phenobarbital (used for treatment of epilepsy)



phenytoin (used for treatment of epilepsy)

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



rifampicin (used to treat tuberculosis and some other infections)



gemfibrozil (used for treatment of high lipid levels in plasma)

Your doctor will determine how Singulair should be used depending
on the symptoms and severity of your asthma.

Taking Singulair with food and drink
Singulair 10 mg may be taken with or without food.

What is asthma?
Asthma is a long-term disease.

Pregnancy and breast-feeding

Asthma includes:

Use in pregnancy



difficulty breathing because of narrowed airways. This
narrowing of airways worsens and improves in response to
various conditions.

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.



sensitive airways that react to many things, such as cigarette
smoke, pollen, cold air, or exercise.

Use in breast-feeding



swelling (inflammation) in the lining of the airways.

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

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

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.

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



palpitations (Rare)



nosebleed (Uncommon)

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.



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)

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.

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 store above 30°C. Store in the original package.

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 use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



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.

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 placebo (a pill containing no
medication).

6. FURTHER INFORMATION
What Singulair contains


Each film-coated tablet contains 10.4mg of the active
ingredient, montelukast sodium (equivalent to 10mg
montelukast).



Singulair also contain the following: microcrystalline cellulose,
lactose monohydrate, croscarmellose sodium, hydroxypropyl
cellulose, magnesium stearate, hypromellose, titanium dioxide
(E171), red iron oxide (E172), yellow iron oxide (E172) and
carnauba wax.
What Singulair Tablets looks like and contents of the pack

The frequency of possible side effects listed below is defined using
the following convention:

Singulair is a beige, rounded square tablet marked ‘SINGULAIR’ on
one side and ‘MSD 117’ on the other.

Very common (affects at least 1 user in 10)

Singulair is available as blister packs of 28 tablets.

Common (affects 1 to 10 users in 100)

Product Licence holder

Rare (affects 1 to 10 users in 10,000)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

Very rare (affects less than 1 user in 10,000)

Manufacturer

Additionally, while the medicine has been on the market, the
following have been reported:

Singulair is manufactured by Merck Sharp & Dohme Limited,
Shotton Lane, Cramlington, Northumberland NE23 3JU.

Uncommon (affects 1 to 10 users in 1,000)



upper respiratory infection (Very common)



increased bleeding tendency (Rare)

Leaflet revision date: 18 December 2012



allergic reactions including swelling of the face, lips, tongue,
and/or throat which may cause difficulty in breathing or
swallowing (Uncommon)

Singulair is a registered trade mark of Merck & Co Inc, USA.





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)

POM PL No. 19488/0534

S534 LEAFLET Singulair 20121218

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.

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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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