Montelukast Sodium Oral granules

What is this medicine?

MONTELUKAST (mon te LOO kast) is used to prevent and treat the symptoms of asthma. It is also used to treat allergies. Do not use for an acute asthma attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• liver disease
• an unusual or allergic reaction to montelukast, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. This medicine may be taken with or without food. For asthma, take this medicine once a day in the evening. For allergies, take this medicine once a day, at about the same time each day. Do not stop taking your medicine unless your doctor tells you to.

Do not open the packet until ready to use. After opening the packet, the dose must be given within 15 minutes. The granules can be placed directly into the mouth. Or, the granules can be mixed in one teaspoonful of baby formula or breast milk or in one teaspoon of applesauce, carrots, rice, or ice cream. Do not mix with any liquids except formula or breast milk. Discard any unused medicine and mixture.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine has been used in children as young as 12 months of age to control asthma and as young as 6 months of age to control allergies.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for the next dose, skip the missed dose. Do not use double or extra doses.

What may interact with this medicine?

• carbamazepine
• paclitaxel
• phenobarbital
• phenytoin
• repaglinide
• rifabutin
• rifampin
• rosiglitazone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or health care professional if your allergy or asthma symptoms do not improve. Take your medicine even when you do not have symptoms. Do not stop taking any of your medicine(s) unless your doctor tells you to.

If you have asthma, talk to your doctor about what to do in an acute asthma attack. Always have your inhaled rescue medicine for asthma attacks with you.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, or swelling of the face, lips, or tongue
• breathing problems
• dark urine
• fever or infection
• flu-like symptoms
• painful lumps under the skin
• pain, tingling, numbness in the hands or feet
• sinus pain or swelling
• suicidal thoughts or other mood changes
• unusual bleeding or bruising
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough
• dizziness
• drowsiness
• headache
• stomach upset
• stuffy nose
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at a room temperature of 59 to 86 degrees F (15 to 30 degrees C). Protect from light and moisture. Keep in the original package. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.