MEDICATION GUIDE

What is the most important information I should know about montelukast sodium oral granules?

Serious mental health problems have happened in people taking montelukast sodium oral granules or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking montelukast sodium oral granules and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking, including any of these symptoms:

What are montelukast sodium oral granules?

Montelukast sodium oral granules are a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and inflammation of the lining of the nose (allergic rhinitis). Montelukast sodium oral granules do not contain a steroid.

Montelukast sodium oral granules are used to:

1. Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older.

Do not take montelukast sodium oral granules if you need relief right away for a sudden asthma attack. If you have an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.

2. Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose, and itching of the nose. Montelukast sodium oral granules are used to treat the following in people who have already taken other medicines that did not work well enough or in people who could not tolerate other medicines:

• outdoor allergies that happen part of the year (seasonal allergic rhinitis) in adults and children ages 2 years and older, and
• indoor allergies that happen all year (perennial allergic rhinitis) in adults and children ages 6 months and older.

Do not take montelukast sodium oral granules if you are allergic to any of their ingredients. See the end of this Medication Guide for a complete list of the ingredients in montelukast sodium oral granules.

Before taking montelukast sodium oral granules, tell your healthcare provider about all your medical conditions, including if you:

• are allergic to aspirin.
• have or have had mental health problems.
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant, as montelukast sodium oral granules may not be right for you.
• are breastfeeding or plan to breastfeed. It is not known if montelukast passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking montelukast sodium oral granules.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast sodium oral granules work, or montelukast sodium oral granules may affect how your other medicines work.

How should I take montelukast sodium oral granules?

For anyone who takes montelukast sodium oral granules:

• Read the detailed Instructions for Use that comes with montelukast sodium oral granules.

• Take montelukast sodium oral granules exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much montelukast sodium oral granules to take, and when to take them.
• Stop taking montelukast sodium oral granules and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking.
• You can take montelukast sodium oral granules with food or without food. See the section "How should I give montelukast sodium oral granules to my child?" in the Instructions for Use for information about what foods and liquids can be taken with montelukast sodium oral granules.
• If you or your child misses a dose of montelukast sodium oral granules, just take the next dose at your regular time. Do not take 2 doses at the same time.
• If you take too many montelukast sodium oral granules, call your healthcare provider right away.

  For adults and children 12 months of age and older with asthma:

• Take montelukast sodium oral granules 1 time each day, in the evening. Continue to take montelukast sodium oral granules every day for as long as your healthcare provider prescribes it, even if you have no asthma symptoms.
• Tell your healthcare provider right away if your asthma symptoms get worse, or if you need to use your rescue inhaler medicine more often for asthma attacks.
• Always have your rescue inhaler medicine with you for asthma attacks.
• Continue to take your other asthma medicines as prescribed unless your healthcare provider tells you to change how you take these medicines.
• Do not take 2 doses of montelukast sodium oral granules within 24 hours (1 day).

For anyone 2 years of age and older with seasonal allergic rhinitis, or for anyone 6 months of age and older with perennial allergic rhinitis:

• Take montelukast sodium oral granules 1 time each day, at about the same time each day.

What should I avoid while taking montelukast sodium oral granules?

If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking montelukast sodium oral granules.

How should I store montelukast sodium oral granules?

• Store montelukast sodium oral granules at room temperature between 68° to 77°F (20° to 25°C).
• Keep montelukast sodium oral granules in the package they come in.
• Keep montelukast sodium oral granules in a dry place and keep it away from light.
• Keep montelukast sodium oral granules and all medicines out of reach of children.

General information about the safe and effective use of montelukast sodium oral granules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use montelukast sodium oral granules for a condition for which they were not prescribed. Do not give montelukast sodium oral granules to other people even if they have the same symptoms you have. They may harm them.

You can ask your pharmacist or healthcare provider for information about montelukast sodium oral granules that is written for health professionals. For more information, call 1-888-838-2872.