Prescription Drug Information: Zetonna (Page 4 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose.

The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used.

Contents under Pressure

Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.

Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum.

ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g.

NDC Number 70515-737-60

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling accompanying the product.

Local Nasal Effects

Inform patients that treatment with ZETONNA may lead to adverse reactions, which include nasal septal perforation, epistaxis, and nasal ulceration. In addition, ciclesonide is associated with candidal infection, and nasal corticosteroids are associated with impaired wound healing. Do not spray ZETONNA directly onto the nasal septum. Patients who have experienced recent nasal septal perforation, nasal erosion, nasal ulcers, nasal surgery, or nasal trauma should not use ZETONNA until healing has occurred [see Warnings and Precautions (5.1) ].

Glaucoma and Cataracts

Inform patients that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Instruct patients to inform his/her health care provider if a change in vision is noted while using ZETONNA [see Warnings and Precautions (5.2) ].

Immunosuppression

Warn patients who are on immunosuppressive doses of corticosteroids to avoid exposure to chickenpox or measles, and if exposed, to consult their physician without delay. Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex [see Warnings and Precautions (5.4) ].

Use Daily

Instruct patients to use ZETONNA on a regular, once daily basis since its effectiveness depends on its regular use. In clinical trials, the onset of effect was seen after 36 hours following the first dose. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing. Initial assessment of response should be made during this timeframe and periodically until the patient’s symptoms are stabilized. Instruct the patient to take the medication as directed, not exceed the prescribed dosage, and contact the physician if symptoms do not improve by a reasonable time or if the condition worsens.

Keep Spray Out of Eyes and Off Nasal Septum

Instruct patients to avoid spraying ZETONNA in their eyes or directly on the nasal septum.

Storage and Handling

Instruct patients to use the ZETONNA canister only with the ZETONNA actuator supplied with the product. The dose indicator display window will show a red zone when it is about time to replace the ZETONNA. Replace ZETONNA when the indicator shows zero.

Manufactured for:
Covis Pharma
Zug, 6300 Switzerland
Made the United Kingdom
© 2018 Covis Pharma and AstraZeneca Group of companies. All rights reserved.

Patient Information

ZETONNA® <<Ze toe’ nah>>
(ciclesonide) Nasal Aerosol

Note: For Use in the Nose Only.

Do not spray ZETONNA Nasal Aerosol in your eyes or directly onto your nasal septum (the wall between the 2 nostrils).
Do not use your ZETONNA Nasal Aerosol near heat or an open flame.

Read this Patient Information leaflet before you start using ZETONNA Nasal Aerosol and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about ZETONNA Nasal Aerosol, ask your healthcare provider or pharmacist.

What is ZETONNA Nasal Aerosol?

ZETONNA Nasal Aerosol is a prescription medicine that treats seasonal and year-round allergy symptoms in adults and children 12 years of age and older.

ZETONNA Nasal Aerosol contains ciclesonide, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body and reduce inflammation. When you spray ZETONNA Nasal Aerosol into your nose, it may help reduce nasal symptoms of allergic rhinitis (inflammation of the lining of the nose) such as stuffy nose, runny nose, itching and sneezing. ZETONNA Nasal Aerosol may also help you if you have red, itchy, and watery eyes.

It is not known if ZETONNA Nasal Aerosol is safe and effective in children 11 years of age and younger.

Who should not use ZETONNA Nasal Aerosol?

Do not use ZETONNA Nasal Aerosol if you are allergic to ciclesonide or any of the ingredients in ZETONNA Nasal Aerosol. See the end of this Patient Information leaflet for a complete list of ingredients in ZETONNA Nasal Aerosol.

What should I tell my healthcare provider before using ZETONNA Nasal Aerosol?

Before you use ZETONNA Nasal Aerosol tell your healthcare provider if you:

have had recent nose problems such as a hole in the cartilage of your nose, nasal ulcers, nasal surgery, or nasal injury.
have or have had eye problems such as increased intraocular pressure, glaucoma, or cataracts.
have any infections including tuberculosis or ocular herpes simplex.
have not had or been vaccinated for chicken pox or measles.
are pregnant or plan to become pregnant. It is not known if ZETONNA Nasal Aerosol will harm your unborn baby. Talk to your healthcare provider about the best way to feed your baby if you are using ZETONNA Nasal Aerosol.
are breastfeeding or plan to breastfeed. It is not known if ZETONNA Nasal Aerosol passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you are using ZETONNA Nasal Aerosol.

Tell your healthcare provider about all the medicines you take , including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctors and pharmacist when you get a new medicine.

How should I use ZETONNA Nasal Aerosol?

Read the Instructions for Use at the end of this leaflet for specific information about the right way to use ZETONNA Nasal Aerosol.
Use ZETONNA Nasal Aerosol exactly as your healthcare provider tells you to use it. Do not take more of your medicine or take it more often than your healthcare provider tells you.
ZETONNA Nasal Aerosol is used 1 time each day, 1 spray in each nostril. Do not use more than a total of 1 spray in each nostril per day.
ZETONNA Nasal Aerosol may begin to work within 36 hours after you take your first dose. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing.
If your symptoms do not improve or get worse, call your healthcare provider.

What are the possible side effects of ZETONNA Nasal Aerosol?

ZETONNA Nasal Aerosol may cause serious side effects, including:

nose bleeds and nasal ulcers. Call your healthcare provider right away if you start to have more nose bleeds or nasal ulcers.
hole in the cartilage in the nose (nasal septal perforation). Stop using ZETONNA Nasal Aerosol and call your doctor right away if you have symptoms of a nasal perforation. Symptoms of nasal perforation may include:
crusting in the nose
nosebleeds
runny nose
whistling sound when you breathe
thrush (Candida), a fungal infection in your nose, mouth, or throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
slow wound healing. You should not use ZETONNA Nasal Aerosol until your nose has healed, if you have a sore in your nose, if you have had surgery in your nose, or if your nose has been injured.
eye problems such as glaucoma and cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use ZETONNA Nasal Aerosol.
immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that may weaken your body’s ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use ZETONNA Nasal Aerosol. Symptoms of an infection may include:
fever
pain
aches
chills
feeling tired
nausea
vomiting
adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Call your healthcare provider right away if you experience the following symptoms of adrenal insufficiency:
tiredness
weakness
dizziness
nausea
vomiting
slowed or delayed growth in children. A child’s growth should be checked regularly while using ZETONNA Nasal Aerosol.
allergic reactions. Call your healthcare provider right away if you experience swelling of the lips, tongue, or throat.

The most common side effects with ZETONNA Nasal Aerosol include:

Nasal discomfort
Headache
Nose bleeds

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ZETONNA Nasal Aerosol.

For more information, ask your doctor or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZETONNA Nasal Aerosol?

Store ZETONNA Nasal Aerosol at room temperature between 59°F and 86°F (15°C to 30°C).
Do not puncture the ZETONNA Nasal Aerosol canister.
Do not store the ZETONNA Nasal Aerosol canister near heat or a flame. Temperatures above 120°F (49°C) may cause the canister to burst.
Do not throw the ZETONNA Nasal Aerosol canister into a fire or an incinerator.
Safely throw away medicine that is out of date or no longer needed.
Keep ZETONNA Nasal Aerosol clean and dry at all times.

Keep ZETONNA Nasal Aerosol and all medicines out of the reach of children.

General Information About the Safe and Effective Use of ZETONNA Nasal Aerosol

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZETONNA Nasal Aerosol for a condition for which it was not prescribed. Do not give ZETONNA Nasal Aerosol to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information about ZETONNA Nasal Aerosol. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ZETONNA Nasal Aerosol that is written for health professionals. You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished your medicine.

What are the ingredients in ZETONNA Nasal Aerosol?

Active ingredient: ciclesonide

Inactive ingredients: HFA propellant and ethanol

Instructions for Use

ZETONNA® <<Ze toe’ nah>>

(ciclesonide)

Nasal Aerosol

Read these Instructions for Use for ZETONNA Nasal Aerosol before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

Note: For Use in the Nose Only.

Do not spray ZETONNA Nasal Aerosol in your eyes or directly onto your nasal septum (the wall between your 2 nostrils).
Do not use your ZETONNA Nasal Aerosol near heat or an open flame.

The Parts of Your ZETONNA Nasal Aerosol

ZETONNA Nasal Aerosol comes as a canister fitted into a nasal actuator with a dose indicator. Do not use the actuator with a canister of medicine from any other inhaler. Do not use the ZETONNA Nasal Aerosol canister with an actuator from any other inhaler. (See Figure A)

Figure A
(click image for full-size original)

Figure A

Priming Your ZETONNA Nasal Aerosol For Use

Remove ZETONNA Nasal Aerosol from its package.
Before you use ZETONNA Nasal Aerosol for the first time or if you have not used your medicine for 10 days in a row, you will need to prime your ZETONNA Nasal Aerosol.
Open the purple plastic dust cap by gently squeezing both sides and pulling the cap away from the nasal actuator. Hold the nasal actuator upright. (See Figure B)
Figure B
(click image for full-size original)

Figure B

Spray 3 times into the air away from the face, by pressing down fully on the top of the canister three times (See Figure C). Make sure the canister returns to its original position after each spray.
Figure C
(click image for full-size original)

Figure C

Using Your ZETONNA Nasal Aerosol

Step 1. Open the purple plastic dust cap.
Step 2. Hold the nasal actuator upright, with the nose piece pointing upwards, between your thumb and forefinger (and middle finger) (See Figure D).
Figure D

Figure D

Step 3. Tilt your head back slightly and insert the end of the nose piece into 1 nostril, pointing it slightly toward the outside nostril wall away from the nasal septum (the wall between the 2 nostrils), while holding your other nostril closed with 1 finger (See Figure E). Do not get any spray in your eyes or directly on your nasal septum.
Figure E
(click image for full-size original)

Figure E

Step 4. Press down on the canister to release 1 spray and at the same time breathe in gently through the nostril. Hold your breath for a few seconds then breathe out slowly through your mouth.
Step 5. Remove the nose piece from your nostril. Make sure the canister has returned to its original position and repeat steps 2-4 for the second spray in your other nostril.
Step 6. Replace the protective purple dust cap on the nasal actuator.
Step 7. Avoid blowing your nose for the next 15 minutes.

Cleaning Your Nasal Actuator

The outside of the nose piece should be cleaned weekly, by wiping with a clean, dry tissue or cloth (see Figure F).

Do not wash or put any part of the ZETONNA Nasal Aerosol canister or actuator in water.

Figure F
(click image for full-size original)

Figure F

How to Tell if Your ZETONNA Nasal Aerosol Is Empty

Each canister of ZETONNA Nasal Aerosol contains enough medicine for you to spray medicine 60 times (or 30 times for sample size product). This does not count the first 3 priming sprays.
The actuator of your ZETONNA Nasal Aerosol is fitted with a dose indicator which shows you how much medicine is left after each use. The dose indicator will display the number of sprays remaining in groups of 5 or 10 actuations.
The display window will begin showing a green color. As you continue to use the medicine, the window will show a yellow color. A yellow color in the window means that you need to replace your medicine soon. When the medicine is almost empty, the window will show a red color.
When the window shows red and you see the dose indicator read zero, “0” (see Figure G), you should throw away the canister and nasal actuator.
Figure G

Figure G

Do not throw your ZETONNA Nasal Aerosol canister in the fire or an incinerator.
Do not use your ZETONNA Nasal Aerosol after zero is shown in the window of the dose indicator even though it may look like there is medicine left in the canister. You may not get the right amount of medicine.
Talk with your healthcare provider before your supply of ZETONNA Nasal Aerosol runs out to see if you should get a refill of your medicine.

What to Do if You Drop Your ZETONNA Nasal Aerosol

If you drop your ZETONNA Nasal Aerosol, the canister may become separated from the actuator. If this happens, insert the canister into the actuator as shown in Figure H , test spray once into the air away from your face, then use as described above.
Figure H
(click image for full-size original)

Figure H

If the ZETONNA Nasal Aerosol is dropped, the dose counter may not work. It is recommended to keep track of the number of sprays taken from your ZETONNA Nasal Aerosol based on your records.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for:
Covis Pharma Zug, 6300 Switzerland

Made in the United Kingdom

© 2018 Covis Pharma and AstraZeneca Group of companies. All rights reserved.

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