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PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST

5mg chewable tablets For children from 6 to 14 years

What is in this leaflet:

1.    What montelukast 5mg is and what it is used for

2.    What you need to know before you take montelukast 5mg

3.    How to take montelukast 5mg

4.    Possible side effects

5.    How to store montelukast 5mg

6.    Contents of the pack and other information

1. What Montelukast 5mg is and what it is used for

The active substance in Montelukast 5mg is montelukast, which is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.

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 may also be used as an alternative treatment to inhaled corticosteroids for 6 to 14 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.

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

Your doctor will determine how montelukast should be used depending on the symptoms and severity of your child's 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, cold air, or exercise.

•    swelling (inflammation) in the lining of the airways.

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

Tell your doctor about any medical problems or allergies your child has now or has had.

Do not give montelukast to your child if he/she

- is allergic to montelukast (the active substance) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

•    If your child’s 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 or your child. Always have your child’s 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 used instead of other asthma medications your doctor has prescribed for your child.

•    Any patient on anti-asthma medicines should be aware that if you develop a combination of symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.

•    Your child should not take aspirin (acetyl-salicyclic acid) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her 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 your

child’s other medicines work.

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any

other medicines.

Tell your doctor if your child is 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 5mg chewable tablets should not be taken immediately with food; it should be

takenl hour before or 2 hours after food.

Pregnancy, breast-feeding and fertility

Women who are pregnant, think they may be pregnant or planning to have a baby, should ask their 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. Women who are breast-feeding or intend to breast-feed, should ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This subsection is not applicable for the montelukast 5mg tablets since they are intended for use in children 6 to 14 years of age, however the following information is relevant to the active ingredient, montelukast.

Montelukast is not expected to affect the 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 chewable tablets contain aspartame, a source of phenylalanine May be harmful for people with phenylketonuria (a rare hereditary disorder of metabolism).

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:

Children aged between 6 and 14 years: one Montelukast 5mg chewable tablet once daily. Tablet should be taken in the evening at least 1 hour before or 2 hours after a meal.

If your child takes more montelukast than he/she should

If your child has accidentally taken too much montelukast, or if someone else has taken your medicine by mistake, contact your doctor immediately. 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 give montelukast to your child

Try to take montelukast as prescribed. However, if your child misses 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 your child stops taking montelukast

Montelukast can treat your child’s asthma only if your child continues to take it.

It is important to continue taking montelukast for as long as your doctor prescribes. It will help control your child’s asthma. It should be taken even when your child has no symptoms or has 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 chewable tablets containing 5mg montelukast, the most commonly reported side effects (affecting up to 1 in 10 paediatric patients treated) were 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 heart beat, 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 multiforme).

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.

Store in the original package, in order to protect from light.

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

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

Do not throw away any medicines 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 chewable tablet contains montelukast sodium, which is equivalent to 5mg monte-lukast.

The other ingredients are: microcrystalline cellulose, mannitol, crospovidone type B, red iron oxide (E172), hydroxypropylcellulose, disodium edetate, cherry flavour, aspartame (E951), talc, magnesium stearate.

What montelukast looks like and contents of the pack

Montelukast 5mg chewable tablets are pink, round, biconvex tablets with "M5" engraved on one side.

Montelukast is available in blister packs of 10, 20, 28, 30, 50, 90 and 100 tablets or 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 August 2013.

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

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