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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Montelukast

What is in this leaflet:

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

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

3.    How to take Montelukast 10 mg

4.    Possible side effects

5.    How to store Montelukast 10 mg

6.    Contents of the pack and other information

Other medicines and Montelukast 10 mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Montelukast 10 mg 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, Montelukast 10 mg 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 10 mg to treat asthma, preventing your asthma symptoms during the day and night.

•    Montelukast 10 mg is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.

•    Montelukast 10 mg also helps prevent the narrowing of airways triggered by exercise.

•    In those asthmatic patients in whom Montelukast 10 mg is indicated in asthma, Montelukast 10 mg can also provide symptomatic relief of seasonal allergic rhinitis.

Your doctor will determine how Montelukast 10 mg 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.

Some medicines may affect how Montelukast 10 mg works, or Montelukast 10 mg may affect how other medicines work.

Tell your doctor if you are taking the following medicines before starting Montelukast 10 mg:

•    phenobarbital (used for treatment of epilepsy)

•    phenytoin (used for treatment of epilepsy)

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

Montelukast 10 mg with food and drink

Montelukast 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 Montelukast 10 mg. Your doctor will assess whether you can take Montelukast 10 mg during this time.

Use in breast-feeding It is not known if Montelukast 10 mg appears in breast milk. You should consult your doctor before taking Montelukast 10 mg if you are breast-feeding or intend to breast-feed.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Montelukast 10 mg 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 10 mg may affect some patients’ ability to drive or operate machinery.

Montelukast 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.

Do not take Montelukast 10 mg

• if you are allergic (hypersensitive) to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before

taking Montelukast 10 mg:

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

•    Oral Montelukast 10 mg 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 take all asthma medications prescribed by your doctor. Montelukast 10 mg 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 lung (pulmonary) problems, and/or rash, you should consult your doctor.

•    You should not take aspirin or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.

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

•    You should take only one tablet of Montelukast 10 mg once a day as prescribed by your doctor.

•    It should be taken even when you have no symptoms or have an acute asthma attack.

•    To be taken by mouth.

The usual dose is:

For adults and adolescents 15 years of age and older:

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

Montelukast 10 mg may be taken with or without food.

If you are taking Montelukast 10 mg, be sure that you do not take any other products that contain the same active ingredient, montelukast.

Montelukast 10 mg should not be used in children below 15 years of age due to the high content of active substance.

Other dosage forms with appropriate strengths are available for younger children.

If you take more Montelukast 10 mg 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.