Synonyms: Simplyone
Ciclesonide / Formoterol is used for:
Long-term treatment of asthma. It may be used to prevent breathing problems in certain patients, including patients with nighttime asthma, or breathing problems caused by exercise. It may be used for long-term treatment of chronic obstructive pulmonary disease (COPD). It may also be used for other conditions as determined by your doctor.
Ciclesonide / Formoterol is a long-acting beta-agonist bronchodilator. It widens the airways in the lungs, which helps you breathe more easily.
Do NOT use Ciclesonide / Formoterol if:
•you are allergic to any ingredient in Ciclesonide / Formoterol
•you are using another medicine that has a long-acting beta-agonist (eg, salmeterol) in it
•you are having an asthma attack (eg, sudden severe onset or worsening of asthma symptoms such as chest tightness, cough, shortness of breath, or wheezing)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Ciclesonide / Formoterol:
Some medical conditions may interact with Ciclesonide / Formoterol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
•if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
•if you have allergies to medicines, foods, or other substances
•if you have had a severe allergic reaction to milk protein or are lactose intolerant
•if you have a history of diabetes, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), high blood pressure, low blood potassium levels, seizures, or an overactive thyroid
•if you have recently been to the emergency room for asthma, have a history of frequent hospitalizations for asthma, or have ever had a life-threatening asthma attack
•if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
•if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline) or you have taken either of these medicines within the last 14 days
Some MEDICINES MAY INTERACT with Ciclesonide / Formoterol. Tell your health care provider if you are taking any other medicines, especially any of the following:
•Corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), or xanthines (eg, theophylline) because the risk of low blood potassium or irregular heartbeat may be increased
•Catechol-o-methyltransferase (COMT) inhibitors (eg, entacapone), long-acting beta-agonists (eg salmeterol), MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Ciclesonide / Formoterol's side affects
•Beta-blockers (eg, propranolol) because they may decrease Ciclesonide / Formoterol's effectiveness or worsen your condition
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ciclesonide / Formoterol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Ciclesonide / Formoterol:
Use Ciclesonide / Formoterol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
•Ciclesonide / Formoterol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ciclesonide / Formoterol refilled.
•Ciclesonide / Formoterol is for inhalation only. Do NOT swallow the capsule.
•Store Ciclesonide / Formoterol in the original blister in a dry place. Do not remove from the blister or the foil until right before use. Be sure your hands are completely dry before you handle the capsules.
•Use the new inhaler that comes with each refill. Do not reuse an old inhaler. Do not use Ciclesonide / Formoterol with a different kind of inhaler. Do not try to use a spacer device with Ciclesonide / Formoterol.
•To prepare the device for use, remove the inhaler cover. Hold the base of the inhaler in one hand. Twist the mouthpiece toward the arrow. Then push in the buttons on each side to make sure that you can see 4 pins in the capsule chamber.
•Place a capsule in the capsule chamber in the base of the inhaler. Do NOT place a capsule in the mouthpiece of the inhaler. Twist the mouthpiece back to the closed position. Hold the mouthpiece of the inhaler upright and press both buttons at the same time. You should hear a click as the capsule is pierced. Do NOT press the buttons more than once. Release the buttons. If they stay stuck, pull them out using the wings on the buttons. Do not press the buttons again.
•In rare cases, the gelatin capsule might break into small pieces. These tiny pieces may reach the mouth or the throat after you inhale. This will not harm you. However, to avoid this, store Ciclesonide / Formoterol properly, remove the capsule from the blister right before use, and pierce the capsule only once.
•To use a dose of Ciclesonide / Formoterol, breathe out fully. Do NOT exhale into the device for any reason. Keep the inhaler level, with the buttons to the left and the right (not up and down). Tilt your head back slightly. place the mouthpiece in your mouth and close your lips around it. Breathe in quickly and deeply though your mouth and hold your breath. You should hear a whirring noise and experience a sweet taste in your mouth.
•If you do not hear a whirring noise, the capsule may be stuck. If this occurs, open the inhaler and loosen the capsule by allowing it to spin freely. Do NOT push the buttons again. Then, repeat the inhalation process. If you are not sure if you are receiving your dose correctly, contact your doctor or pharmacist.
•After breathing in your dose, remove the inhaler from your mouth. Continue to hold your breath for as long as possible. Then, breathe out slowly.
•Open the inhaler to see if any powder is still in the capsule. If any powder remains in the capsule, close the inhaler. Repeat the inhalation process. Most people are able to empty the capsule in 1 or 2 inhalations.
•After you have taken your dose, open the inhaler, remove the capsule, and throw it away. Do not leave a used capsule in the inhaler. Close the mouthpiece and replace the cover.
•If you are using Ciclesonide / Formoterol to prevent breathing problems caused by exercise, use it at least 15 minutes before you start to exercise. Do not use another dose for at least 12 hours. If you already used Ciclesonide / Formoterol twice daily on a regular basis, do NOT take an extra dose before you exercise.
•Never wash the mouthpiece or any part of the inhaler. Keep it dry and always store it in a dry place. Do NOT try to take the inhaler apart.
•Continue to use Ciclesonide / Formoterol even if you feel well. Do not miss any doses.
•If you miss a dose of Ciclesonide / Formoterol, use it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Ciclesonide / Formoterol.
Important safety information:
•Ciclesonide / Formoterol may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ciclesonide / Formoterol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
•Ciclesonide / Formoterol will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator inhaler with you at all times to treat any breathing problems that may occur between doses of Ciclesonide / Formoterol (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
•If you have been regularly using a short-action bronchodilator inhaler (eg, albuterol), talk with your doctor about how to use it with Ciclesonide / Formoterol. Short-acting bronchodilators are normally used with Ciclesonide / Formoterol to treat breathing problems that may occur between doses.
•The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Ciclesonide / Formoterol in high doses. Do NOT use more than recommended dose or use more often than prescribed.
•If your symptoms do not get better within 1 week of starting Ciclesonide / Formoterol, or if they get worse, contact your doctor right away.
•Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often (eg, 4 or more times a day for more than 2 days in a row, more than one canister in 8 weeks), or if you have a decrease in your peak flow meter results.
•Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.
•Ciclesonide / Formoterol is not to be used in place of a corticosteroid. If you are using a corticosteroid medicine for asthma, do not stop or reduce the dose unless your doctor tells you to.
•Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
•The medicine may cause severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.
•Ciclesonide / Formoterol may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
•Lab tests, including lung function and blood potassium levels, may be performed while you use Ciclesonide / Formoterol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
•Caution is advised when using Ciclesonide / Formoterol in CHILDREN; they may be more sensitive to its effects, especially nausea, stomach pain, and stomach upset.
•Ciclesonide / Formoterol should be used with extreme caution in CHILDREN younger than 5 years old; safety and effectiveness in these children have not been confirmed.
•pregnancy and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Ciclesonide / Formoterol during pregnancy. It is not known if Ciclesonide / Formoterol is found in breast milk. If you are or will be breast-feeding while you use Ciclesonide / Formoterol, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Ciclesonide / Formoterol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
•Dizziness; dry mouth; headache; nausea; nervousness; stomach pain or upset; stuffy nose; throat irritation; tiredness; tremor; trouble sleeping.
Seek medical attention right away if any of these SEVERE side effects occur:
•Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); chest pain; fast or irregular heartbeat; fever, chills, or persistent sore throat; new or worsening asthma symptoms (eg, increased chest tightness, coughing, shortness of breath, wheezing); severe or persistent headache, dizziness, tremor, or nervousness; severe or persistent muscle pain or cramps; trouble speaking.
This is not a complete list of all side effects that may occur. Call your doctor for medical advice about side effects.
Proper storage of Ciclesonide / Formoterol:
Store Ciclesonide / Formoterol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and direct sunlight. Do not use Ciclesonide / Formoterol if it is past the “use by” date on the container. Keep Ciclesonide / Formoterol out of the reach of children and away from pets.
General information:
•If you have any questions about Ciclesonide / Formoterol, please talk with your doctor, pharmacist, or other health care provider.
•Ciclesonide / Formoterol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
•If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Ciclesonide / Formoterol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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