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PACKAGE LEAFLET: INFORMATION FOR THE USER SINGULAIR® 10MG TABLETS/MONTELUKAST 10MG TABLETS/ MONTEGEN® 10MG TABLETS

(montelukast sodium)

This product is available as any of the above names but will be referred to as Singulair throughout this leaflet.

Read all of this leaflet carefully before you start 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 you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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 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

Singulair is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your 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 non-steroidal 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 breast-feeding or intend to breastfeed.

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 10mg tablet to be taken daily in the evening. Singulair 10mg 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.