500437/PL1f    ®

Singulair® 10 mg Film Coated Tablets

(montelukast sodium)

Package Leaflet: Information for the User

The name of your medication is Singulair® 10 mg Film Coated

Tablets. Throughout this leaflet, it will be referred to as

®

Singulair .

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.

•    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.

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.

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.

•    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 nonsteroidal 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 breastfeeding 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.

•    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.

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 product, ask your doctor or pharmacist.

4) POSSIBLE SIDE EFFECTS

Like all medicines, Singulair 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

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)

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

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

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, 1517 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 Ginova Ltd or Ginova UK Ltd.)

500444/PL1f

Montelukast 10 mg Film Coated Tablets

(montelukast sodium)

Package Leaflet: Information for the User

The name of your medication is Montelukast 10 mg Film Coated Tablets. Throughout this leaflet, it will be referred to as Montelukast.

In this leaflet:

1)    What Montelukast is and what it is used for

2)    Before you take Montelukast

3)    How to take Montelukast

4)    Possible side effects

5)    How to store Montelukast

6)    Further information

Montelukast 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, Montelukast improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

Your doctor has prescribed Montelukast to treat asthma, preventing your asthma symptoms during the day and night.

•    Montelukast is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.

•    Montelukast also helps prevent the narrowing of airways triggered by exercise.

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

Your doctor will determine how Montelukast 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.

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

Do not take Montelukast if you

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

Take special care with Montelukast

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

•    Oral Montelukast 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. Montelukast 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 anti-inflammatory medicines (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.

Use in children

For children 2 to 5 years old, Montelukast Paediatric 4 mg chewable tablets and Montelukast Paediatric 4 mg granules are available.

For children 6 to 14 years old, Montelukast Paediatric 5 mg chewable tablets are available.

Taking other medicines

Some medicines may affect how Montelukast works, or Montelukast 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 Montelukast:

•    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 Montelukast with food and drink

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

Use in breast-feeding

It is not known if Montelukast appears in breast milk. You should consult your doctor before taking Montelukast if you are breast-feeding or intend to breast-feed.

Driving and using machines

Montelukast 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 Montelukast may affect some patients' ability to drive or operate machinery.

Important information about some of the ingredients of Montelukast

Montelukast 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 MONTELUKAST|

•    You should take only one tablet of Montelukast 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 Montelukast 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. Montelukast 10 mg may be taken with or without food.

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

If you take more Montelukast 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 Montelukast

Try to take Montelukast 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 Montelukast

Montelukast can treat your asthma only if you continue to take it.

It is important to continue taking Montelukast 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.

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

In clinical studies with Montelukast 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 Montelukast were:

•    abdominal pain

•    headache

These were usually mild and occurred at a greater frequency in patients treated with Montelukast than with a 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)

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

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

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, 1517 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 Ginova Ltd or Ginova UK Ltd.)

|5) HOW TO STORE MONTELUKAST|

•    Keep out of the sight and reach 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.

•    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.

•    If you notice any sign of discolouration or deterioration of the tablets consult your pharmacist.

What Montelukast contains

•    The active substance is: montelukast

•    Each tablet contains 10.4 mg montelukast sodium

equivalent to 10 mg montelukast.

The other ingredients 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 Montelukast looks like and contents of the pack

Montelukast is supplied as beige, rounded square, film-coated tablets engraved '117' on one side and plain on the other.

Pack size: 28 tablets in calendar blister packs.

Product Licence Holder and Manufacturer

Manufactured by Merck Sharp & Dohme Limited, Shotton Lane, Cramlington, Northumberland NE23 3JU, UK.

Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent DA11 0HJ.

Montelukast 10 mg Film Coated Tablets

PL No: 18067/0227

Date of revision: 30^th September 2014.

500444/PL1f