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Alvesco

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Alvesco

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Alvesco Consumer (continued)

SIDE EFFECTS: See also Precautions section.

Dry/irritated throat, hoarseness, a bad taste in the mouth, or coughing may occur. If any of these effects persist or worsen, tell your doctor or pharmacist 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: white patches in your mouth or on your tongue.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes, unusual/persistent headache, poor wound healing, puffy face, unexpected weight gain, muscle pain/weakness, mental/mood changes (e.g., depression, agitation), increased thirst/urination.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and seek immediate medical attention.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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.

Read the Alvesco (ciclesonide inhalation aerosol) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: Before using ciclesonide, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., beclomethasone, fluticasone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: tuberculosis, untreated infections (e.g., fungus, bacteria), certain eye problems (glaucoma, cataracts, herpes infection of the eye), liver disease, adrenal gland problems (e.g., adrenal insufficiency), underactive thyroid (hypothyroidism), bone loss (osteoporosis).

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Avoid exposure to chickenpox or measles infection while taking 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.

This medication may mask signs of infection or put you at greater risk of developing an infection. Report any signs of infection (e.g., persistent sore throat, fever, cough, changes in sputum color) that occur during treatment.

When used for extended periods, medications similar to ciclesonide may affect bone strength, especially in people who smoke, have a family history of brittle bones (osteoporosis), or take other medications that may weaken bones (e.g., phenytoin). Bone density tests may help to determine whether you need medication to treat or prevent this problem. Consult your doctor for more information.

This medication may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell the doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

It is not known whether this drug passes into breast milk. Therefore, consult your doctor before breast-feeding.

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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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