SINGULAIR 10MG TABLETS

Active substance: MONTELUKAST SODIUM

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This product is known as the above name but will be referred to as Singulair throughout this leaflet.
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

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

PROOF HISTORY:
v.1 - waymade - 21/10/13

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.

WARNING!

27mm

SINGULAIR® 10mg TABLETS
(montelukast sodium)
Patient Information Leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000B

Take special care with Singulair
• If your asthma or breathing gets worse, tell your doctor immediately.

DATE:

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.



21/10/13

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.



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.

DATE OF PROOF:

DT

04-1957

ARTWORKER:

PRE-PRESS NO.:

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.


Q.A.
APPROVED:



Taking other medicines
Some medicines may affect how Singulair works, or Singulair may affect how other medicines work.

TO UK PIL DATED DECEMBER 2012
REPORTING SIDE EFFECTS

6464/1711D
CODE:

Singular 10mg tabs
PRODUCT:

CUSTOMER: Waymade

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
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

WARNING!

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

2. Before you take Singulair
Tell your doctor about any medical problems or allergies you have now or have had.
DATE:

CUSTOMER
APPROVED:

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.

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.

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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).

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)
• 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)

DATE:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 21/10/13

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)

04-1957

DT

DATE OF PROOF:

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

21/10/13

ARTWORKER:

DATE:

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.

PRE-PRESS NO.:

Q.A.
APPROVED:

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.

By reporting side effects you can help provide more information on the safety of this medicine.






TO UK PIL DATED DECEMBER 2012
REPORTING SIDE EFFECTS

6464/1711D
CODE:

Singular 10mg tabs
PRODUCT:

CUSTOMER: Waymade



5. How to store Singulair
Singulair 10mg tablets should not be stored above 30°C.
Store in the original package. Do not remove the tablet from the calendar pack until you are ready to
take it.
Do not use after the expiry date printed on the carton label or blister strip.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
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.

6. Further information
Your medicine is called Singulair 10mg tablets. Each tablet contains 10.4mg of the active ingredient,
montelukast sodium equivalent to 10mg of montelukast acid in a beige, rounded square film coated tablet
marked 'MSD 117' on one side and marked with ‘Singulair’ on the reverse.
Singulair 10mg tablets also contain the following inactive ingredients:
lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose,
hydroxypropyl cellulose, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and
carnauba wax.
Singulair 10mg tablets are available as calendar blister packs of 28 tablets.
POM

PL No: 6464/1711

This product is manufactured by Merck Sharp & Dohme Ltd, Shotton Lane, Cramlington, England and
procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 21.10.2013
Singulair is a registered trademark of Merck Sharp & Dohme Ltd.
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 Waymade Plc and Merck Sharp & Dohme Limited.)

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

WARNING!

If you take more Singulair than you should
Contact your doctor immediately for advice.

WARNING!

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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.

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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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