Montelukast Chewable Tablets

Montelukast Chewable Tablets are used for:

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Prevention and long-term treatment of asthma. It is also used in certain patients to relieve runny nose caused by allergy and to prevent asthma attacks caused by exercise. It may also be used for other conditions as determined by your doctor.

Montelukast Chewable Tablets are 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
• if you have a history of mental or mood problems, or suicidal thoughts or actions

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.
• Take Montelukast Chewable Tablets by mouth 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 and 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 are found in breast milk. If you are or will be breast-feeding while you use 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.

Severe allergic reactions (rash; hives; itching; 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; mental or mood changes; new or worsening wheezing or other breathing problems; numbness or tingling of hands or feet; seizures; severe or persistent stomach pain; severe sinus inflammation; suicidal thoughts or actions; 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Symptoms may include hyperactivity; severe or persistent headache; stomach pain; unusual drowsiness or restlessness; unusual thirst; vomiting.

Store at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Protect from light and moisture. Store in original packaging until just before use. Do not store in the 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 are 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.

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