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MONTELUKAST GRANULES-ORAL (cont.)

SIDE EFFECTS: Unusual weakness, stomach upset, diarrhea, dizziness, cough, headache, nausea, vomiting, trouble sleeping, or mouth pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: hallucinations, fever, persistent sore throat or earache, flu symptoms. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: stomach pain, muscle aches/cramps, irregular heartbeat, yellowing eyes and skin, numbness or tingling of the hands or feet, dull sense of touch, easy bruising or bleeding, swelling, seizures. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, severe swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before using this drug, tell your doctor or pharmacist your medical history, especially of: allergies (especially drug allergies), liver disease. Use of this medication in children under the age of 1 year is not recommended. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug is excreted into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: rifamycin antibiotics (e.g., rifampin), certain drugs which stimulate liver metabolism (e.g., phenytoin, phenobarbital, carbamazepine), other asthma drugs. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include thirst, drowsiness, dilated pupils, increased muscle movements, or severe stomach pain.




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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