Omnaris (Ciclesonide)

(sye kles' oh nide)

Ciclesonide nasal spray is used to treat the symptoms of seasonal (occurs only at certain times of the year), and perennial (occurs all year round) allergic rhinitis. These symptoms include sneezing and stuffy, runny or itchy nose. Ciclesonide is in a class of medications called corticosteroids. It works by preventing and decreasing inflammation (swelling that can cause other symptoms) in the nose.

Ciclesonide comes as a solution (liquid) to spray in the nose. It is usually sprayed in each nostril once daily. Use ciclesonide at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ciclesonide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Ciclesonide nasal spray is only for use in the nose. Do not swallow the nasal spray and be careful not to spray it in your eyes or directly onto the nasal septum (the wall between the two nostrils). Ciclesonide controls the symptoms of rhinitis but does not cure it. Your symptoms probably will not begin to improve for at least 24-48 hours after your first dose and it may be longer before you feel the full benefit of ciclesonide. Continue to use ciclesonide even if you feel well. Do not stop taking ciclesonide without talking to your doctor. Each bottle of ciclesonide nasal spray is designed to provide 120 sprays after the bottle is primed initially. The bottle must be disposed of after 4 months of use. You should count 4 months from the date that the bottle is removed from the foil pouch and write it on the sticker that is provided in the carton. Place the sticker in the space provided on the bottle to remind you of this date. It is also important to keep track of the number of sprays you have used and dispose of the bottle after you have used 120 sprays, even if the bottle still contains some liquid and it is before the 4 months have passed. To use the nasal spray, follow these steps:

• Shake the bottle gently and remove the dust cover.
• If you are using the pump for the first time, point the bottle away from your body and press down and release the pump eight times. If you have used the pump before but not within the last 4 days, press down and release the pump one time or until you see a fine spray.
• Blow your nose until your nostrils are clear.
• Hold one nostril closed with your finger.
• With your other hand, hold the bottle firmly with your forefinger and middle finger on either side of the spray tip while supporting the base of the bottle with your thumb.
• Tilt your head slightly forward and carefully put the tip of the nasal applicator into your open nostril keeping the bottle upright. Begin to breathe through your nose.
• While you are breathing in, use your forefinger and middle finger to press quickly and firmly down on the applicator and release a spray.
• Repeat steps 4-7 in the other nostril, unless your doctor has told you otherwise.
• Wipe the applicator tip with a clean tissue and replace the dust cover.

Before using ciclesonide nasal spray,
• Tell your doctor and pharmacist if you are allergic to ciclesonide; any other nasal corticosteroid such as beclomethasone (Beconase AQ), budesonide (Rhinocort Aqua), fluticasone (Flonase), momentasone (Flonase), triamcinolone (Nasacort AQ); or any other medications.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or have recently taken. Be sure to mention ketoconazole (Nizoral) or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol) and prednisone (Deltasone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have or have ever had tuberculosis (TB), cataracts (clouding of the lens in your eye), or glaucoma (an eye disease), and if you now have sores in your nose, any type of untreated infection, or a herpes infection of your eye (a type of infection that causes a sore on the eyelid or surface of your eye). Also tell your doctor if you have recently had surgery on your nose or injured your nose in any way.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ciclesonide, call your doctor.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ciclesonide.
• If you have been taking oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisolone (Pediapred, Prelone) or prednisone (Deltasone) your doctor may want to gradually decrease your steroid dose after you begin using ciclesonide. Special caution is needed for several months as your body adjusts to the change in medication.
• If you have any other medical conditions, such as asthma, arthritis, or eczema (a skin disease), they may worsen when your oral steroid dose is decreased. Tell your doctor if this happens or if you experience any of the following symptoms during this time: extreme tiredness, muscle weakness or pain; sudden pain in stomach, lower body or legs; loss of appetite; weight loss; upset stomach; vomiting; diarrhea; dizziness; fainting; depression; irritability; and darkening of skin. Your body may be less able to cope with stress such as surgery, illness, severe asthma attack, or injury during this time. Call your doctor right away if you get sick and be sure that all health care providers who treat you know that you recently replaced your oral steroid with ciclesonide inhalation. Carry a card or wear a medical identification bracelet to let emergency personnel know that you may need to be treated with steroids in an emergency.You should know that ciclesonide may decrease your ability to fight infection. Stay away from people who are sick and wash your hands often. Be especially careful to stay away from people who have chicken pox or measles. Tell your doctor right away if you find out that you have been around someone who has one of these viruses.

Unless your doctor tells you otherwise, continue your normal diet.

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Ciclesonide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nosebleed
• burning or irritation in the nose
• earache

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• painful white patches in nose or throat
• flu-like symptoms
• vision problems
• injury to nose
• new or increased acne (pimples)
• easy bruising
• enlarged face and neck
• extreme tiredness
• muscle weakness
• irregular menstruation (periods)
• hives
• rash
• itching
• swelling of the face, throat, lips, eyes, hands, feet, ankles or lower legs
• hoarseness
• difficulty breathing or swallowing
• wheezing

Ciclesonide may cause children to grow more slowly. It is not known whether using ciclesonide decreases the final adult height that children will reach. Talk to your doctor about the risks of giving this medication to your child. Ciclesonide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

If someone swallows ciclesonide, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor. If your applicator becomes clogged, remove the dust cap and gently pull upwards to free the nasal applicator. Wash the dust cap and applicator with warm water. Dry and replace the applicator and press down and release the pump one time or until you see a fine spray. Replace the dust cap. Do not use pins or other sharp objects in the tiny spray hole on the nasal applicator to remove the blockage. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.