Alvesco

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

See also Precautions section.

Dry/irritated throat, hoarseness, a bad taste in the mouth, or coughing may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: white patches in your mouth or on your tongue, headache that doesn't go away, vision changes, poor wound healing, puffy face, unexpected weight gain, muscle pain/weakness, mental/mood changes (such as depression, agitation), increased thirst/urination.

Rarely, 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 get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are: aldesleukin, desmopressin, corticosteroids taken by mouth (such as prednisone, dexamethasone), mifepristone.

Other medications can affect the removal of ciclesonide from your body, which may affect how ciclesonide works. Examples include some azole antifungals (such as ketoconazole), HIV protease inhibitors (such as nelfinavir), ritonavir, among others.

Store at room temperature away from heat. Do not freeze. Do not puncture the canister or use near an open flame. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Do not share this medication with others.

Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow/red range or increased use of quick-relief inhalers).

Lab and/or medical tests (such as morning cortisol levels, eye exams, bone density tests) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Avoid allergens (such as pollen), irritants, smoking/secondhand smoke, and other factors that make asthma worse.

Most people with asthma or ongoing lung disease should receive a flu shot every year. Discuss this with your doctor.

In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that reduce the risk of bone loss include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Read the Patient Information Leaflet provided by your pharmacist before you start using ciclesonide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Inhale this medication by mouth as directed by your doctor. No shaking of the inhaler is necessary before use. If the inhaler is new or has not been used for 1 week or more, prime the inhaler for use by spraying 3 puffs into the air. Remove the cover on the mouthpiece. Breathe out as much as you comfortably can. Place the mouthpiece into your mouth and close your lips tightly around it. While breathing in slowly and deeply, press down on the canister with your finger. After inhaling, try to hold your breath for at least 10 seconds to get this medication into your lungs and allow it to work properly.

Dosage is based on your medical condition and response to treatment.

A spacer device may be used with this medication if you find it difficult to use this inhaler. Ask your doctor or pharmacist for more information.

If your prescribed dose is 2 puffs, wait at least one minute between them. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug (the corticosteroid) last.

To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle, rinse your mouth with water and spit out after each use. Do not swallow the rinse water.

Clean the mouthpiece once a week with a dry tissue. Do not wet the mouthpiece to clean it.

Use this medication regularly to get the most benefit from it. This medication works best when used at evenly spaced intervals. To help you remember, use it at the same time each day. Do not increase your dose, use this inhaler more often, or stop using it without first consulting your doctor.

Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

You may begin to feel this medication working within 24 hours, but it may take several weeks or longer before the full benefit of this drug takes effect. Tell your doctor if your symptoms do not get better or if they get worse.

Before using ciclesonide, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as 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 (such as those caused by fungus or bacteria), certain eye problems (glaucoma, cataracts, herpes infection of the eye), liver disease, adrenal gland problems (such as 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. 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.

This medication may mask signs of infection. It can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

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 (such as 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 temporarily slow down a child's growth if used for a long time. However, poorly controlled asthma can also slow down growth. 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.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.