Singulair 10mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Montelukast sodium
Available from:
CST Pharma Ltd
ATC code:
R03DC03
INN (International Name):
Montelukast sodium
Dosage:
10mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 03030200; GTIN: 5055946807089

Singulair 10mg film-coated tablets

(montelukast sodium)

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine

because it contains important information for you.

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

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

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This medicine has been prescribed for you only. Do not pass it on to

others. It may harm them, even if their signs of illness are the same as

yours.

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If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Singulair 10mg film-coated tablets but will be

referred to as Singulair throughout the leaflet.

What is in this leaflet:

What Singulair is and what it is used for

What you need to know before you take Singulair

How to take Singulair

Possible side effects

How to store Singulair

Contents of the pack and other information

What Singulair is and what it is used for

What Singulair is

Singulair is a leukotriene receptor antagonist that blocks substances called

leukotrienes.

How Singulair works

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).

When Singulair should be used

Your doctor has prescribed Singulair to treat asthma, preventing your

asthma symptoms during the day and night.

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Singulair is used for the treatment of adults and adolescents 15 years of

age and older who are not adequately controlled on their medication and

need additional therapy.

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Singulair also helps prevent the narrowing of airways triggered by

exercise.

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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:

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difficulty breathing because of narrowed airways. This narrowing of

airways worsens and improves in response to various conditions.

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sensitive airways that react to many things, such as cigarette smoke,

pollen, or cold air, or exercise.

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swelling (inflammation) in the lining of 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.

What you need to know 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 to montelukast or any of the other ingredients of this

medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Singulair.

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

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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.

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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.

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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.

Patients should be aware that various neuropsychiatric events (for example

behaviour and moodrelated changes) have been reported in adults,

adolescents and children with Singulair (see section 4).

If you develop such symptoms while taking Singulair, you should consult

your doctor.

Children and adolescents

Do not give this medicine to children less than 15 years of age.

There are different form(s) of this medicine available for paediatric patients

under 18 years of age based on age range.

Other medicines and Singulair

Tell your doctor or pharmacist if you are taking or have recently taken or

might take any other medicines including those obtained without a

prescription.

Some medicines may affect how Singulair works, or Singulair may affect

how other medicines work.

Tell your doctor if you are taking the following medicines before starting

Singulair:

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phenobarbital (used for treatment of epilepsy)

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phenytoin (used for treatment of epilepsy)

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rifampicin (used to treat tuberculosis and some other infections)

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

Singulair with food and drink

Singulair 10 mg film-coated tablet may be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are

planning to have a baby, ask your doctor or pharmacist for advice before

taking Singulair.

Pregnancy

Your doctor will assess whether you can take Singulair during this time.

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

with Singulair may affect some patients’ ability to drive or operate machinery.

Singulair 10 mg film-coated tablets contain lactose and sodium

If you have been told by your doctor that you have an intolerance to some

sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol (23mg) per tablet, that is to say

essentially ‘sodium-free’.

How to take Singulair

Always take this medicine exactly as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

*

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.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet to be taken daily in the

evening.

If you are taking Singulair, be sure that you do not take any other products

that contain the same active ingredient, montelukast.

This medicine is for oral use.

You can take Singulair 10 mg with or without food.

®

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Patient Information Leaflet (continued)

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 medicine, ask your

doctor or pharmacist.

Possible side effects

Like all medicines, this medicine 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 (may affect up to 1 in 10 people) thought to

be related to Singulair were:

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abdominal pain

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headache

These were usually mild and occurred at a greater frequency in patients

treated with Singulair than placebo (a pill containing no medication).

Serious side effects

Talk with your doctor immediately if you notice any of the following side

effects, which may be serious, and for which you may need urgent medical

treatment.

Uncommon: the following may affect up to 1 in 100 people

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allergic reactions including swelling of the face, lips, tongue, and/or throat

which may cause difficulty in breathing or swallowing

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behaviour and mood related changes: agitation including aggressive

behaviour or hostility, depression

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seizure

Rare: the following may affect up to 1 in 1,000 people

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increased bleeding tendency

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tremor

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palpitations

Very rare: the following may affect up to 1 in 10,000 people

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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) (see Section 2)

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low blood platelet count

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behaviour and mood related changes: hallucinations, disorientation,

suicidal thoughts and actions

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swelling (inflammation) of the lungs

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severe skin reactions (erythema multiforme) that may occur without

warning

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inflammation of the liver (hepatitis)

Other side effects while the medicine has been on the market

Very common: the following may affect more than 1 in 10 people

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upper respiratory infection

Common: the following may affect up to 1 in 10 people

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diarrhoea, nausea, vomiting

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rash

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fever

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elevated liver enzymes

Uncommon: the following may affect up to 1 in 100 people

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behaviour and mood related changes: dream abnormalities, including

nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious,

restlessness

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dizziness, drowsiness, pins and needles/numbness

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nosebleed

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dry mouth, indigestion

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bruising, itching, hives

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joint or muscle pain, muscle cramps

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bedwetting in children

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weakness/tiredness, feeling unwell, swelling

Rare: the following may affect up to 1 in 1,000 people

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behaviour and mood related changes: disturbance in attention, memory

impairment, uncontrolled muscle movements

Very rare: the following may affect up to 1 in 10,000 people

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tender red lumps under the skin, most commonly on your shins (erythema

nodosum)

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behaviour and mood related changes: obsessive-compulsive symptoms,

stuttering

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 or search for MHRA Yellow Card in the

Google Play or Apple App Store. By reporting side effects you can help

provide more information on the safety of this medicine.

How to store Singular

Keep out of the sight and reach of children.

Do not store above 30°C.

Store in the original package in order to protect from light and moisture.

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.

If your medicine becomes discoloured or shows any signs of deterioration,

ask your pharmacist who will advise you what to do.

Medicines should not be disposed of via waterwaste or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These

measures will help to protect the environment.

Contents of the pack and other information

What Singular contains

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

The other ingredients are:

Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium,

hydroxypropylcellulose, and magnesium stearate.

Film coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E 171),

red ferric oxide (E 172), yellow ferric oxide (E 172) and carnauba wax.

What Singular looks like and the contents of the pack

Singulair tablets are beige, rounded square, film-coated with SINGULAIR

engraved on one side and MSD 117 on the other.

Blisters in packages of 28 tablets.

Manufacturer and Licence Holder

The tablets are manufactured by Merck Sharp & Dohme Ltd., Cramlington,

Northumberland NE23 3JU, UK and are procured from within the EU and

repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,

Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

Information is given by:

Asthma UK, 18 Mansell Street London E1 8AA. Alternatively phone the

Asthma UK Helpline on 0300 222 5800, Monday to Friday 9 am to 5 pm,

calls charged at local rate.

(The Asthma UK is independent charity working to conquer asthma and is

not associated with Merck Sharp & Dohme Limited.)

PL 15184/1411

Singulair is a registered trademark of Merck Sharp & Dohme Corp.

Revision date: 03/10/19

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet

in a format suitable for you

Ref: 1411/031019/1/B

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POM

Singulair 10mg film-coated tablets

(montelukast sodium)

®

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