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budesonide/formoterol (4.5 micrograms) hfa inhaler - oral, Symbicort (cont.)

SIDE EFFECTS: Headache, nausea, nervousness, trouble sleeping, cough, hoarseness, or throat irritation may occur. If any of these effects persist or worsen, tell your doctor promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: increased thirst/urination, mental/mood changes (e.g., agitation, depression), muscle cramps, persistent weight gain, shaking (tremors), vision problems (e.g., blurred vision), white patches on tongue/in mouth.Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fast/slow/irregular heartbeat, severe dizziness, fainting.A very serious allergic reaction to this product is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, sudden trouble breathing.Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you have trouble breathing or experience sudden wheezing, use your quick-relief inhaler and seek immediate medical attention.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to budesonide or formoterol; or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, bone loss (osteoporosis), depression, diabetes, eye problems (e.g., cataracts, glaucoma), heart problems (e.g., angina, irregular heartbeat), any recent infection, liver problems, overactive thyroid (hyperthyroidism), seizures, smoking.Budesonide/formoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using budesonide/formoterol, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using budesonide/formoterol safely.Avoid exposure to chickenpox or measles infection while using this medication unless you have previously had these infections (e.g., in childhood). If you are exposed to one of these infections and you have not previously had it, seek immediate medical attention.If you have switched from an oral corticosteroid (e.g., prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses and suddenly stop using it, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids, especially if your body is stressed due to a major infection, surgery, or injury. Deaths due to low steroid levels have sometimes occurred during such stresses. Tell your doctor immediately if any of the following side effects occur: unusual/extreme tiredness, weight loss.Consult your doctor or pharmacist for more details, and tell them that you use (or have used) any type of corticosteroid. Carry a warning card or medical ID bracelet that identifies your need for oral corticosteroids during times of stress. Consult your doctor or pharmacist now for specific advice about stress situations. You may need to carry a supply of corticosteroid tablets as a precaution.Caution is advised when using this drug in children because there is a slight risk that it may temporarily slow down a child's growth rate, but this will probably not affect final adult height. Though this effect is rare with inhaled steroids such as budesonide, monitor your child's height regularly.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.Budesonide passes into breast milk. It is not known whether formoterol passes into breast milk. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.



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