Alvesco 160mcg Inhaler- 6.1 g

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.

CICLESONIDE HFA INHALER - ORAL

(sye-KLES-oh-nide)

COMMON BRAND NAME(S): Alvesco

USES: Ciclesonide is used to prevent and reduce the symptoms (wheezing and shortness of breath) caused by asthma. Controlling asthma symptoms may decrease time lost from work or school. This medication belongs to a class of drugs known as corticosteroids. It works by reducing the swelling of the airways in the lungs to make breathing easier. This medication must be taken regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed. Keep track of how often you need to use your quick-relief inhaler, and tell your doctor. If your quick-relief inhaler does not seem to work as well, if you need to use more than usual of your quick-relief inhaler for 2 or more days in a row, or if you need to use more than one full canister of your quick-relief inhaler over a 2-month period, seek immediate medical attention.

HOW TO USE: 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 yeast infections in the mouth (thrush), gargle and rinse your mouth with water 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 frequently, 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 improve or if they worsen.

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 right away if any of these unlikely but serious side effects occur: white patches in your mouth or on your tongue. Tell your doctor right away 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 or at www.fda.gov/medwatch. 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 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 right away 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.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. Before using ciclesonide, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aldesleukin, corticosteroids taken by mouth (e.g., prednisone, dexamethasone), mifepristone, drugs affecting the removal of ciclesonide from your system (potent CYP 3A4 inhibitors such as ketoconazole, itraconazole, nelfinavir, ritonavir). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: 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). Tell all your doctors that you use, or have used, this medication. Keep all medical appointments. Laboratory and/or medical tests (e.g., morning cortisol levels, eye exams, bone density tests) may be performed to monitor your progress and check for side effects. Avoid allergens (e.g., 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).

MISSED DOSE: 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 and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

MEDICAL ALERT: 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).

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.