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PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST 10mg film-coated tablets For adolescents and adults from 15 years

What is in this leaflet:

1.    What montelukast 10mg is and what it is used for

2.    What you need to know before you take montelukast 10mg

3.    How to take montelukast 10mg

4.    Possible side effects

5.    How to store montelukast 10mg

6.    Contents of the pack and other information

1. What Montelukast is and what it is used for

The active substance in Montelukast 10mg is montelukast, which 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, which 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, or 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 to montelukast (the active substance) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

•    Montelukast is not intended for the treatment of 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 your child takes 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 aspirin (acetyl-salicyclic acid) 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, Montelukast 4mg chewable tablets are available

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

Other medicines and montelukast

Some medicines may affect how montelukast works, or montelukast may affect how other medicines work.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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)

Montelukast with food, drink and alcohol

Montelukast 10mg film-coated tablets may be taken with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. . Your doctor will assess whether you can take montelukast during this time.

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.

Montelukast 10mg film-coated tablets contain lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure

The recommended dose is: Adolescents aged 15 years and older and adults take one Montelukast 10mg film-coated tablet in the evening. Montelukast 10mg may be taken with or without food.

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 taking it.

It is important for you to continue taking montelukast for as long as your doctor prescribes.

It will help control your asthma. It should be taken even when you have no symptoms or have an acute asthma attack.

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

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

Stop taking montelukast and see a doctor or go to a hospital straight away if:

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to montelukast.

In clinical studies with film-coated tablets containing 10mg montelukast , the most commonly reported side effects (affecting up to 1 in 10 patients) were stomach-ache and headaches.

Additionally, while the medicine has been on the market, the following have been reported: Very common (may affect more than 1 in 10 people)

Infection of the nose and throat.

Common (may affect up to 1 in 10 people)

Diarrhoea, feeling sick (nausea), being sick (vomiting), increased liver enzyme levels, rash, fever.

Uncommon (may affect up to 1 in 100 people)

Allergic reactions (including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing), abnormal dreams (e.g. nightmares), difficulty in sleeping (insomnia), sleepwalking, irritability, hostility, feeling anxious, restlessness, agitation including aggressive behaviour, depression, dizziness, drowsiness, paraesthesia (pins and needles/numbness), seizures, nosebleed, dry mouth, indigestion, bruising, nettle rash, itching, painful joints, muscle pain, muscle spasms, fatigue, general feeling of being unwell, swelling (oedema).

Rare (may affect up to 1 in 1,000 people)

Increased tendency to bleed, shaking (tremor), feeling your heartbeat, rapid swelling of the skin tissue (angioedema).

Very rare (may affect up to 1 in 10,000 people)

Hepatic problems (liver eosinophilic infiltration), hallucinations, disorientation, suicidal thinking and actions inflammation of the liver (hepatitis), tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema mutliforme).

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 lung 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.

If you get any side-effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and outer packaging (EXP). The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration (change of colour, etc.)

Do not throw away any medcines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What montelukast contains

The active substance is: montelukast (as montelukast sodium).

One film-coated tablet contains montelukast sodium, which is equivalent to 10mg of montelukast.

The other ingredients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, disodium edetate, magnesium stearate

Tablet coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)

What montelukast looks like and contents of the pack

Montelukast 10mg film-coated tablets are beige-coloured, round, biconvex film-coated tablets.

Montelukast is available in blister packs of 10, 20, 28, 30, 50, 90 and 100 tablets and bottles of 10, 20, 28, 30, 50, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Winthrop Pharmaceuticals,

PO Box 611,

Guildford,

Surrey,

GU1 4YS, UK or

Zentiva,

One Onslow Street,

Guildford,

Surrey,

GU1 4YS, UK

Manufacturer

Takeda Pharma Sp.z.o.o.

Ul.Ksiesta Lowickiego 12 99-420 Lyszkowice Poland

or

Zentiva S.A.,

50, Theodor Pallady Blvd.,

032266, Bucharest,

Romania

or

HBM Pharma s.r.o. Sklabinska 30 036 80 Martin Slovak Republic

This leaflet was last revised in May 2013.

‘Winthrop’ is a registered trademark. © 2013 Winthrop Pharmaceuticals. or

‘Zentiva’ is a registered trademark. © 2013 Zentiva.