Omnaris Nasal Spray (Ciclesonide)

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

If you switched to ciclesonide from another steroid medicine, do not stop using the other steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about tapering your steroid dose before stopping completely.

OMNARIS is usually used once per day. The usual dose of Omnaris is 2 sprays in each nostril once daily. The usual dose of Zetonna is 1 spray in each nostril once daily. Carefully follow your doctor's dosing instructions.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Shake the Omnaris bottle well just before each use.

To use the nasal spray:

• Blow your nose gently. Keep your head upright and insert the tip of bottle into one nostril. Press your other nostril closed with your finger. Breathe in quickly and gently spray the medicine into your nose. Then use the spray in your other nostril.
• Do not blow your nose for at least a few minutes after using the nasal spray.
• Do not use the nasal spray more than once in a 24-hour period.
• If the spray gets in your eyes or mouth or on your skin, rinse with water.

It may take up 2 to 5 weeks before your symptoms improve. Call your doctor if your symptoms do not improve, or if they get worse.

If you use this medicine long-term, you may need frequent eye exams.

Store this medicine in an upright position at room temperature, away from moisture and heat. Do not allow the medicine to freeze. Keep the spray bottle clean and dry.

Keep the Zetonna canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

Throw away the Omnaris nasal spray after you have used 120 sprays or 4 months after removing the bottle from the foil pouch, even if there is still medicine left in the bottle.

Seek emergency medical attention or call the Poison Help line.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nasal steroid medicine can be absorbed into your bloodstream, which may cause steroid side effects throughout the body. Tell your doctor if you have:

• weight gain (especially in your face or your upper back and torso);
• slow wound healing, thinning skin, increased body hair;
• irregular menstrual periods, changes in sexual function; or
• muscle weakness, tired feeling, depression, anxiety, feeling irritable.

Call your doctor at once if you have:

• runny or bloody nose, crusting inside the nose, whistling sound when you breathe;
• sores or white patches in or around your nostrils;
• fever, chills, body aches, nausea, vomiting;
• blurred vision, tunnel vision, eye pain, seeing halos around lights; or
• signs of a hormonal disorder--worsening tiredness or weakness, feeling light-headed, vomiting, loss of appetite, diarrhea, and weight loss.

Common side effects may include:

• headache, dizziness;
• nosebleed, nasal irritation;
• stuffy nose, sore throat; or
• ear pain.

You should not use this medicine if you are allergic to ciclesonide.

To make sure OMNARIS is safe for you, tell your doctor if you have:

• asthma, tuberculosis, or other lung problems;
• any type of infection caused by bacteria, virus, fungus, or parasites;
• glaucoma, cataracts, or herpes infection of the eyes;
• a sore inside your nose that has not yet healed;
• a recent nose injury or surgery; or
• if you have recently used any other steroid medicine (methylprednisolone, prednisone, beclomethasone, fluticasone, dexamethasone, and others).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether OMNARIS passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Steroid medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Avoid getting this medicine in your eyes. If this does happen, rinse with water and call your doctor.

Steroid medicine can weaken your immune system. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using OMNARIS.

Other drugs may interact with OMNARIS, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.