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|Montelukast Granules

Montelukast Granules

Montelukast Granules is used for:

Prevention and long-term treatment of asthma. It is also used to relieve allergy symptoms. It may also be used for other conditions as determined by your doctor.

Montelukast Granules 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 Granules if:

• you are allergic to any ingredient in Montelukast Granules

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

Before using Montelukast Granules:

Some medical conditions may interact with Montelukast Granules. 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 are having an asthma attack
• if you have liver problems

Some MEDICINES MAY INTERACT with Montelukast Granules. 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 Granules"s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Montelukast Granules 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 Granules:

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

• An extra patient leaflet is available with Montelukast Granules. Talk to your pharmacist if you have questions about this information.
• Montelukast Granules may be taken with or without food.
• Do not open the packet until you are ready to use it.
• Montelukast Granules may be placed directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of soft food at cold or room temperature before swallowing. Soft foods that may be used include applesauce, mashed carrots, rice, or ice cream. Be sure to swallow the entire spoonful right away (within 15 minutes). Do not store mixed medicine for future use.
• Do not put the granules in liquid other than baby formula or breast milk. However, you may drink liquids after swallowing the granules or granule mixture.
• Continue to use Montelukast Granules even if you feel well. Do not miss any doses.
• If you miss a dose of Montelukast Granules, 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 Granules.

Important safety information:

• Montelukast Granules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Montelukast Granules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Montelukast Granules 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 Granules 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.
• Montelukast Granules should be used with extreme caution in CHILDREN younger than 6 months of age; safety and effectiveness in these children have not been confirmed.
• 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 Granules while you are pregnant. It is not known if Montelukast Granules is found in breast milk. If you are or will be breast-feeding while you are using Montelukast Granules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Montelukast Granules:

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; 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.

Store Montelukast Granules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Montelukast Granules out of the reach of children and away from pets.

General information:

• If you have any questions about Montelukast Granules, please talk with your doctor, pharmacist, or other health care provider.
• Montelukast Granules 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 Granules. 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.