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Montelukast Chewable Tablets

Generic Name: Montelukast Chewable Tablets (mon-te-LOO-kast)
Brand Name: Singulair

Montelukast Chewable Tablets is used for:

The prevention and treatment of asthma in adults and children 12 months old and older. It is also used to relieve allergy symptoms (seasonal allergic rhinitis) in patients 2 years old and older.

Montelukast Chewable Tablets is a leukotriene receptor antagonist. It works by blocking a substance called leukotriene, which helps to decrease certain asthma and allergy symptoms.

Do NOT use Montelukast Chewable Tablets if:

you are allergic to any ingredient in Montelukast Chewable Tablets

Contact your doctor or health care provider right away if any of these apply to you.

Before using Montelukast Chewable Tablets:

Some medical conditions may interact with Montelukast Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver problems or phenylketonuria

Some MEDICINES MAY INTERACT with Montelukast Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Certain anticonvulsants (eg, phenobarbital) or rifampin because they may decrease Montelukast Chewable Tablets"s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Montelukast Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Montelukast Chewable Tablets:

Use Montelukast Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Montelukast Chewable Tablets. Talk to your pharmacist if you have questions about this information.
Montelukast Chewable Tablets may be taken with or without food.
Chew thoroughly before swallowing
Continue to use Montelukast Chewable Tablets even if you feel well. Do not miss any doses.
If you miss a dose of Montelukast Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Montelukast Chewable Tablets.

Important safety information:

Montelukast Chewable Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Montelukast Chewable Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Montelukast Chewable Tablets will not stop an asthma attack once one has started. Be sure you always carry appropriate medicine (eg, bronchodilator inhalers) with you in case of an asthma attack.
Contact your doctor promptly if your short-acting inhaler use increases or if use exceeds the 24-hour maximum prescribed by your doctor. Contact your doctor if your asthma worsens.
Do not decrease your dose or stop using Montelukast Chewable Tablets or other asthma medicines without first checking with your doctor.
If your asthma is sensitive to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), continue to avoid those medicines as directed by your doctor.
Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Montelukast Chewable Tablets while you are pregnant. It is not known if Montelukast Chewable Tablets is found in breast milk. If you are or will be breast-feeding while you are using Montelukast Chewable Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Montelukast Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; dizziness; headache; indigestion; nausea; stomach upset or pain; stuffy nose; tiredness; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); aggressive behavior; agitation; dark urine; fever; flu-like symptoms; hallucinations; irregular heartbeat; new or worsening wheezing or other breathing problems; numbness or tingling of hands or feet; seizures; severe or persistent stomach pain; severe sinus inflammation; swelling; unusual bruising or bleeding; upper respiratory tract infection; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include hyperactivity; severe or persistent headache; stomach pain; unusual drowsiness or restlessness; unusual thirst; vomiting.

Proper storage of Montelukast Chewable Tablets:

Store at 77 degrees F (25 degrees C). Excursions permitted to 59 to 86 degrees F (15 to 30 degrees C). Protect from light and moisture. Keep in original package. Do not store in bathroom. Keep Montelukast Chewable Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Montelukast Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
Montelukast Chewable Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Montelukast Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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