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PACKAGE LEAFLET: INFORMATION FOR THE USER

SINGULAIR® Paediatric 4 mg Granules

montelukast

Read all of this leaflet carefully before your child starts taking this medicine.

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

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

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

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What SINGULAIR Paediatric is and what it is used for

2.    Before SINGULAIR Paediatric is taken

3.    How to take SINGULAIR Paediatric

4.    Possible side effects

5.    How to store SINGULAIR Paediatric

6.    Further information

1. WHAT SINGULAIR PAEDIATRIC IS AND WHAT IT IS USED FOR

SINGULAIR Paediatric is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, SINGULAIR Paediatric improves asthma symptoms and helps control asthma.

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

•    SINGULAIR Paediatric is used for the treatment of 6 months to 5 year old patients who are not adequately controlled on their medication and need additional therapy.

•    SINGULAIR Paediatric 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.

•    SINGULAIR Paediatric also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.

Your doctor will determine how SINGULAIR Paediatric 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.

2. BEFORE SINGULAIR Paediatric IS TAKEN

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

Do not give SINGULAIR Paediatric to your child if he/she

• is allergic (hypersensitive) to montelukast or any of the other ingredients of SINGULAIR Paediatric (see 6. Further information).

Take special care with SINGULAIR Paediatric

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

•    Oral SINGULAIR Paediatric is 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. SINGULAIR Paediatric 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.

Taking other medicines

Some medicines may affect how SINGULAIR Paediatric works, or SINGULAIR Paediatric 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 SINGULAIR Paediatric:

•    phenobarbital (used for treatment of epilepsy)

•    phenytoin (used for treatment of epilepsy)

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

Taking SINGULAIR Paediatric with food and drink

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

Pregnancy and breast-feeding

This subsection is not applicable for the SINGULAIR Paediatric 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,    ■ ■■ ■ ■^""onon"^¹

montelukast.

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 breast-feeding or intend to breast-feed.

Driving and using machines

This subsection is not applicable for the SINGULAIR Paediatric 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.

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.

3. HOW TO TAKE SINGULAIR PAEDIATRIC

•    This medicine is to be given to a child under adult supervision. Your child should take SINGULAIR Paediatric 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 SINGULAIR Paediatric 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 SINGULAIR Paediatric 4 mg granules to be taken by mouth each evening.

If your child is taking SINGULAIR Paediatric, 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, SINGULAIR Paediatric 4 mg granules are available.

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

How should I give SINGULAIR Paediatric granules to my child?

•    Do not open the sachet until ready to use.

•    SINGULAIR Paediatric granules can be given either:

-    directly in the mouth;

-    OR mixed with a spoonful of cold or room temperature soft food (for example, applesauce, ice cream, carrots and rice).

•    Mix all of the contents of the SINGULAIR Paediatric 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.

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

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

If your child takes more SINGULAIR Paediatric 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 SINGULAIR Paediatric to your child

Try to give SINGULAIR Paediatric 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 SINGULAIR Paediatric

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

It is important for your child to continue taking SINGULAIR Paediatric 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, SINGULAIR Paediatric can cause side effects, although not everybody gets them.

In clinical studies with SINGULAIR Paediatric 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 SINGULAIR Paediatric were:

•    diarrhoea

•    hyperactivity

•    asthma

•    scaly and itchy skin

•    rash