Patient Medication Information: uses, side effects, how to take - Omnaris HFA
ABOUT THIS MEDICATION
What the medication is used for:
OMNARIS® HFA is used in adults and adolescents 12 years of age and older to treat:
Seasonal allergic rhinitis: Sometimes called “hay fever” and may be caused by allergies to pollen, grass or weeds. Perennial allergic rhinitis: Year round allergies that may be caused by house dust, mould, and pet dander.
What it does:
OMNARIS® HFA is a corticosteroid that is used in the nose. It reduces inflammation in the lining of the nose and nasal passages which helps relieve nasal congestion (blocked nose), runny nose, itching, sneezing and red, itchy, watery eyes.
When it should not be used:
Do not take OMNARIS® HFA if:
you are allergic to ciclesonide or to any of the non-
medicinal ingredients in OMNARIS® HFA;
you have an untreated infection of the nose (i.e. yellow or
green discharge from the nose);
- your nose was recently operated on or injured;
- you are less than 12 years of age.
What the medicinal ingredient is:
Ciclesonide
What the nonmedicinal ingredients are:
Ethanol and HFA-134a (a propellant).
What dosage forms it comes in:
Nasal aerosol: 50 mcg/spray
WARNINGS AND PRECAUTIONS
BEFORE you use OMNARIS® HFA talk to your doctor, nurse or pharmacist if you:
ever had to stop taking other medicines for hay fever
or other allergies because you were allergic to them or experienced other problems;
- have a history of tuberculosis (TB) infections;
- have sores in the nose;
- have an infection (fungal, bacterial, parasitic or viral);
have herpes simplex (virus) infection of the eye;
- are taking other steroid medicine by mouth or by inhalation (breathing in through the nose or mouth);
- are taking drugs that suppress the immune system;
are pregnant, plan to become pregnant or are breastfeeding. Do not use this medication during pregnancy or breastfeeding without first discussing it with your doctor
- Have recently been exposed to chicken pox or measles
- Have a history of increased pressure in your eyes, glaucoma or cataracts
INTERACTIONS WITH THIS MEDICATION
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with OMNARIS® HFA:
- Ketoconazole or Itraconazole (drugs used to treat fungal infections)
- Ritonavir or Nelfinavir (drugs used to treat HIV infection)
PROPER USE OF THIS MEDICATION
Do not spray OMNARIS® HFA in your eyes or directly onto your nasal septum (the wall between the 2 nostrils). Do not use your OMNARIS® HFA near heat or an open flame.
The maximum therapeutic effects of corticosteroids like OMNARIS® HFA are not immediate. It may take a few days for this medicine to reach full effect. It is very important that you use it regularly. Do not stop treatment even if you feel better unless told to do so by your doctor.
Your doctor will decide what an appropriate dosage of OMNARIS® HFA is for you.
Your doctor or pharmacist has explained when and how to take OMNARIS® HFA. Follow your doctor’s or pharmacist’s directions carefully – they may be different from the information provided in this leaflet.
OMNARIS® HFA should be taken once daily. Take your dose at the same time every day.
Usual dose:
Adults and Adolescents (12 Years and Older): The recommended dosage is 1 spray in each nostril once daily. Do not exceed the prescribed dose.
OMNARIS® HFA is not presently approved for use in patients younger than 12 years of age.
How to Use OMNARIS® HFA:
OMNARIS® HFA 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 OMNARIS® HFA canister with an actuator from any other inhaler.
Using the Spray:
- 1. Remove OMNARIS® HFA from its package.
- 2.
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 below).
- 3.
Before you use your OMNARIS® HFAor if you have
not used your OMNARIS® HFA for 7 days in a row, you will need to prime it. Prime by spraying 3 times into the air away from the face, by pressing down fully on the top of the canister three times. Make sure the canister returns to its original position after each spray. See the next figure.
- 4. Blow your nose to clear your nostrils if needed.
- 5. Hold the nasal actuator upright, with the nose piece pointing upwards, between your thumb and forefinger and middle finger (see figure below).
- 6. Tilt your head back slightly and insert the nose piece into one 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 below). Do not get any spray in your eyes or directly on your nasal septum
- 7.
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.
- 8.
Remove the nose piece from your nostril. Make
sure the canister has returned to its original position
- 9.
Repeat steps 6-8 for the second spray in your other
nostril.
- 10.
Return the protective purple dust cap to the closed
position on the nasal actuator. Avoid blowing your nose for the next 15 minutes.
Applicator Cleaning Instructions:
The outside of the nose piece should be cleaned
weekly, by wiping with a clean, dry tissue or cloth (see figure below). Do not wash or put any part of the OMNARIS® HFA canister or actuator in water.
How To Know When Your Nasal Aerosol Is Empty:
Each canister of OMNARIS® HFA 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 OMNARIS® HFA 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 next figure), you should throw away the canister and nasal actuator.
- Do not throw your OMNARIS® HFA canister in the fire or an incinerator.
- Do not use your OMNARIS® HFA after zero is shown in the window of the dose indicator even though it may seem 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
OMNARIS® HFA runs out to see if you should get a refill of your medicine.
What to Do if You Drop Your OMNARIS® HFA If you drop your OMNARIS® HFA the canister may become separated from the actuator. If this happens, insert the canister into the actuator as shown in figure below, test spray once into the air away from your face, then use as described above.
Overdose:
If you think you have taken too much OMNARIS® HFA contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose. 
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- upper respiratory tract infection (ex. colds)
- headache
- cough
- throat pain
- nose-bleeds
discomfort or irritation of the nose (sore nose,
reddening, dryness or crusting in your nose)
- nausea
- muscle pain/cramps
- bronchitis
slower healing of wounds. Do not use OMNARIS®
HFA until your nose has healed if you have a sore nose, surgery on your nose, or if your nose has been injured.
eye problems such as glaucoma or cataracts. You
should have regular eye exams while using OMNARIS® HFA.
immune system problems and worsening of
symptoms of infections, such as existing tuberculosis, fungal, bacterial or parasitic infections or herpes of the eye. Symptoms of infections may include fever, pain, aches, chills, feeling tired, nausea and vomiting.
slower growth of adolescents (12 to 17 years of age)
may occur, and their growth should be monitored regularly while using OMNARIS® HFA.
If any of these affects you severely, tell your doctor, nurse or pharmacist.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist | Stop taking drug and seek immediate medical help | ||
Only if severe | In all cases | |||
| Uncommon | Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | ||
| Uncommon | Nasal Septum Perforation (a hole in the wall between the nostrils):trouble breathing, crusting, nose bleeds, pain and discomfort in the nose | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking OMNARIS® HFA contact your doctor, nurse or pharmacist.
HOW TO STORE IT
Store at controlled room temperature (15°C - 25°C). The container contains a pressurised liquid. Do not freeze. Do not store above 49°C. Do not puncture. Do not use or store near heat or open flame. Never throw canister into fire or incinerator.
Keep out of reach and sight of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: --------------------------------------------------------------------------Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E Ottawa, Ontario K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.takedacanada.com or by contacting the sponsor, Takeda Canada Inc., at: 1-866-295-4636.
Last revised: 10 February 2014
® Registered trademark of Takeda GmbH. Used under licence.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |