MONTELUKAST 4 mg GRANULES For children from 6 months to 5 years of age

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.

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

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

•    This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child's.

•    If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

1.    What Montelukast granules are and what they are used for

2.    What you need to know before you take Montelukast granules

3.    How to take Montelukast granules

4.    Possible side effects

5.    How to store Montelukast granules

6.    Contents of the pack and other information

OWHAT MONTELUKAST GRANULES ARE AND WHAT THEY ARE USED FOR

Montelukast granules are a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your lungs. By blocking leukotrienes, Montelukast granules improve asthma symptoms and help control asthma.

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

• Montelukast granules are used for the treatment of 6 months to 5 year old patients who are not adequately controlled on their medication and need additional therapy • Montelukast granules may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 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 granules also help prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.

Your doctor will determine how Montelukast granules should be used depending on the symptoms and severity of your child's 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 YOU NEED TO KNOW BEFORE YOU TAKE MONTELUKAST GRANULES

Do not use Montelukast granules

If your child is allergic (hypersensitive) to montelukast sodium 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 • Oral Montelukast granules are not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always have your child's inhaled rescue medicine for asthma attacks with you.

• It is important that your child take all asthma medications prescribed by your doctor. Montelukast granules should not be used instead of other asthma medications your doctor has prescribed for your child.

•    If your child is on anti-asthma medicines, be aware that if he/she develops 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 acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.

Other medicines and Montelukast granules

Some medicines may affect how Montelukast granules work, or Montelukast granules may affect how your child's other medicines work.

Please tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including those obtained without a prescription.

Tell your doctor if your child is taking the following medicines before starting Montelukast granules:

•    phenobarbital (used for treatment of epilepsy)

•    phenytoin (used for treatment of epilepsy)

•    rifampicin (used to treat tuberculosis and some other infections)

•    gemfibrozil (used to treat hypertriglyceridaemia, mixed hyperlipidaemia and primary hypercholesterolaemia).

Montelukast granules with food and drink

Montelukast granules can be taken without regard to the timing of food intake.

Pregnancy and breast-feeding

This subsection is not applicable for Montelukast 4 mg granules since they are intended for use in children 6 months to 5 years of age, however the following information is relevant to the active ingredient, montelukast.

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

This subsection is not applicable for Montelukast 4 mg granules since they are intended for use in children 6 months to 5 years of age, however the following information is relevant to the active ingredient, montelukast.

Montelukast has minor influence on the ability to drive and use machines. 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.

©HOW TO TAKE MONTELUKAST GRANULES

• This medicine is to be given to a child under adult supervision. Your child should take Montelukast granules every evening.

• It should be taken even when your child has no symptoms or if he/she has an acute asthma attack

• Always have your child take Montelukast granules as your doctor has told you. You should check with your child's doctor or pharmacist if you are not sure.

• To be taken by mouth.

For children 6 months to 5 years of age:

One sachet of Montelukast 4 mg granules to be taken by mouth each evening.

If your child is taking Montelukast granules, be sure that your child does not take any other products that contain the same active ingredient, montelukast.

For children 6 months to 2 years old, Montelukast 4 mg granules are available.

For children 2 to 5 years old, Montelukast 4 mg chewable tablets and Montelukast 4 mg granules are available. The Montelukast 4 mg granules formulation is not recommended below 6 months of age.

How should I give Montelukast 4 mg Granules to my child?

•    Do not open the sachet until ready to use

•    Montelukast granules can be given either:

•    directly in the mouth

•    OR mixed with a spoonful of cold or room temperature soft food (for example, apple sauce, ice cream, carrots and rice)

•    Mix all of the contents of the Montelukast granules into a spoonful of cold or room temperature soft food, taking care to see that the entire dose is mixed with the food

•    Be sure the child is given the entire spoonful of the granule/food mixture immediately (within 15 minutes). IMPORTANT: Never store any granule/food mixture for use at a later time.

•    Montelukast granules are not intended to be dissolved in liquid. However, your child may take liquids after swallowing the Montelukast granules.

•    Montelukast granules can be taken without regard to the timing of food intake.

If your child takes more Montelukast Granules than he/she should

Contact your child's 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 give Montelukast granules to your child

Try to give Montelukast granules as prescribed. However, if your child misses a dose, just resume the usual schedule of one sachet once daily.

Do not give a double dose to make up for a forgotten dose.

If your child stops taking Montelukast granules

Montelukast granules can treat your child's asthma only if he/she continues taking it.

It is important for your child to continue taking Montelukast granules for as long as your doctor prescribes. It will help control your child's asthma.

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

4 POSSIBLE SIDE EFFECTS

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

The following terms are used to describe how often side effects have been reported:

very common:	affects more than 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
not known:	frequency cannot be estimated from the available data

In clinical studies with montelukast 4 mg granules, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to montelukast were:

•    diarrhoea

•    hyperactivity

•    asthma

•    scaly and itchy skin

•    rash.

Additionally, the following side effects were reported in clinical studies with either montelukast 10 mg Film-coated Tablets or montelukast 5 mg or 4 mg chewable tablets:

•    abdominal pain

•    headache

•    thirst.

These were usually mild and occurred at a greater frequency in patients treated with montelukast 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 rash, 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 (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)

•    bruising, itching, hives (Uncommon); tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) (Very rare)

•    joint or muscle pain, muscle cramps (Uncommon)

•    fever (Common); 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 your child gets one or more of these symptoms.

Reporting of side effects

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

©HOW TO STORE MONTELUKAST GRANULES

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

Do not use this medicine after the date shown on the sachet after EXP 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 in order to protect from light and moisture.

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

©CONTENTS OF THE PACK AND OTHER INFORMATION

What Montelukast granules contain

• The active substance is montelukast. Each sachet of granules contains montelukast sodium which corresponds to 4 mg montelukast.

• The other ingredients are mannitol, hydroxypropyl cellulose, sodium laurilsulfate and magnesium stearate.

What Montelukast granules look like and contents of the pack

Montelukast 4 mg Granules are white to off-white granules.

Cartons of 7, 20, 28, 30 and 98 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK.

Manufacturer

Teva Operations Poland Sp. z o.o. ul. Mogilska 80, 31546 Krakow, Poland.

This leaflet was last revised in January 2015.

PL 00289/1702

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TEVA UK LIMITED 74660-C