Consumer Information for: AERMONY RESPICLICK

What the medication is used for

Aermony Respiclick is used to treat and prevent asthma in people who are 12 years of age and older. It is used by people who need regular treatment for their asthma.

Aermony Respiclick is not meant to be used to provide immediate relief of an asthma attack. A fast acting ‘rescue’ medicine, such as salbutamol, should be used for any sudden asthma attacks.

What it does

Asthma is a lung disease. It is a condition that you can have for a long time. During an asthma attack the airways of your lungs react by swelling and becoming narrow. This makes it more difficult for the air to flow in and out of your lungs.

Fluticasone propionate belongs to a group of medicines called corticosteroids. They reduce the inflammation in the airways of the lungs. This helps you breathe easier.

When it should not be used

Do not use Aermony Respiclick:

to treat sudden symptoms of an asthma attack. Aermony Respiclick is not a rescue inhaler and should not be used to give you fast relief from your asthma attack
if you are allergic to fluticasone propionate
if you have severe allergy to milk proteins
if you are under 12 years of age

What the medicinal ingredient is

Medicinal ingredients: Fluticasone propionate

What the non-medicinal ingredients are

Non-medicinal ingredients: Lactose monohydrate

What dosage form it comes in

Dry powder for inhalation: Each actuation contains: 55 mcg, 113 mcg or 232 mcg fluticasone propionate.

Each inhaler contains 60 actuations.

Warnings and precautions

Serious Warnings and Precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Aermony Respiclick. Talk about any health conditions or problems you may have, including if you:

have ever had to stop taking another medication for your breathing problems because you were allergic to it or it caused problems
are allergic to lactose (milk sugar) or milk protein
are taking other “steroids” by mouth or inhalation
have ever had herpes simplex of the eye, a history of tuberculosis infections or any type of viral, bacterial, fungal (yeast) or parasitic infection
have ever had a yeast infection (thrush) in your mouth
if you have immune system problems
are pregnant, or planning to become pregnant. Tell your doctor right away if you become pregnant while taking Aermony Respiclick.
are breastfeeding or plan to breastfeed. It is not known if the ingredients in Aermony Respiclick can pass into breast milk
are taking medicines used to treat HIV infection or AIDS, such as:
- ritonavir
- atazanavir
- indinavir
- nelfinavir
- saquinavir
You should avoid taking Aermony Respiclick if you are taking ritonavir.
have liver problems or disease

Other warnings you should know about:

Measles and Chickenpox: While taking Aermony Respiclick, you should avoid coming into contact with anyone who has measles or chicken pox. If you or your child(ren) do come into contact with someone who has it, tell your doctor right away.

Effect on Growth: All corticosteroids, especially when taken for a long time, may affect the usual growth pattern in adolescents. Your doctor should monitor you or your child(ren) regularly.

Risk of Bone Fractures: When using medicines like Aermony Respiclick for long term treatment, you may be at risk of:

breaking a bone
osteoporosis (brittle bones)

You should take extra care to avoid any injuries, especially falls. Your doctor should also monitor you.

Eye Disorders: Medicines like Aermony Respiclick can cause eye disorders such as:

Cataracts: clouding of the lens in the eye, blurry vision, eye pain;
Glaucoma: an increased pressure in your eyes, eye pain. If untreated, it may lead to permanent vision loss.
Central serous chorioretinopathy (CSCR): blurry vision or other changes in vision.

You should have regular eye exams.

Monitoring: Ask your doctor whether you need to be monitored in any special way, especially if you:

were previously taking another form of corticosteroids (like an injection or an oral tablet) and have switched to an inhaled corticosteroid. Your doctor should look out for tiredness, weakness, nausea, vomiting and low blood pressure.
are being treated for diabetes. You may need more frequent blood sugar monitoring or a change in the dose of your diabetes medication.

Tell your doctor right away if:

there is a change in your symptoms such as more coughing, attacks of wheezing, chest tightness, or an unusual increase in the severity of the breathlessness
you wake up at night with chest tightness, wheezing or shortness of breath
you are using your rescue inhaler more often
your rescue inhaler does not work well to relieve your symptoms

These could be warning signs that your condition may be getting worse.

Tell your healthcare professional about all the medicines you take including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

The following may interact with Aermony Respiclick:

Ketoconazole (a drug used to treat fungal infections)
Drugs used to treat HIV and AIDS such as:

ritonavir
atazanavir
indinavir
nelfinavir
saquinavir

Antifungal drugs (such as itraconazole)
Clarithromycin (used to treat bacterial infections)
Nefazodone (used to treat depression)
Telithromycin (used to treat pneumonia)
Acetylsalicylic acid (ASA) (used to treat pain and fever)

Proper use of this medication

How to take Aermony Respiclick:

Aermony Respiclick is for oral inhalation only.

It may take up to 1 or 2 weeks for Aermony Respiclick to work. So is important that you use it:

every day
at about the same time each day

After you use it, you should rinse your mouth with water. Spit out the water. Do not swallow the water.

If you are also using an inhaled bronchodilator:

use it first before you use Aermony Respiclick
wait a few minutes and then use Aermony Respiclick

Do not stop taking Aermony Respiclick suddenly – even if you feel better. Your doctor will tell you how to slowly stop taking the medication if necessary.

Do not change the dose unless you are told to by your doctor.

Usual Dose (Adults and Adolescents 12 years of age and older):

Take 1 inhalation twice a day, about 12 hours apart.

Do not take more than the recommended dose.

Instruction for Use:

About the inhaler:
When you are ready to use Aermony Respiclick for the first time, remove the inhaler from the foil pouch. Do not remove the inhaler from the foil pouch until you are ready to use it.

There are 2 main parts of your inhaler: (see Figure A).

the white inhaler with the mouthpiece
the green cap that covers the mouthpiece of the inhaler

Figure A:

IMPORTANT POINTS TO REMEMBER ABOUT USING YOUR INHALER:

One actuation is equal to one dose. An actuation is when you inhale the medication from the mouthpiece into your lungs.
The Aermony Respiclick inhaler does not require priming.
There is no button or canister that you need to press to load a dose. Opening the green cap loads the dose. Every time the green cap is opened and it “clicks”, one dose is ready to be inhaled. If you do not hear the “click” sound the inhaler may not be activated to give you a dose of medicine.
Always close the green cap after using it so your inhaler will be ready for you to take your next dose.
Do not open the cap unless you are ready to take your next dose. Opening and closing the cap without inhaling a dose will waste the medicine and may damage your inhaler.
Your Aermony Respiclick inhaler contains dry powder so it is important that you do not blow or breathe into it.

About the counter:

Your Aermony Respiclick inhaler contains 60 actuations (inhalations).
There is a counter in the back of the inhaler with a viewing window that shows you how much of the medicine you have left (see Figure A).
The counter will count down (in units of two) each time the green cap is opened and closed (for example, 60, 58, 56, etc.).
When there are 20 actuations left, the colour of the numbers will change to red. You should refill your prescription or ask your doctor for another prescription.
When the counter shows the number ‘0’ the background will change to red and the colour of the number ‘0’ will change to black. Your inhaler is empty and you should stop using the inhaler and throw it away (see Figure B).

How to use the Aermony Respiclick:

STEP 1: Open

Figure C:

Make sure the cap is closed.
Hold the inhaler upright (see Figure C).

Figure D:

Open the green cap all the way back until you feel and hear a “click” (see Figure D).
Every time the green cap is opened and it clicks, one dose is ready to be inhaled.

Do not open the green cap unless you are taking a dose.

STEP 2: Inhale

Figure E:

Before inhaling, hold the inhaler away from your mouth and breathe out through your mouth as much air as you can and as is comfortable. Never breathe out into the inhaler mouthpiece (see Figure E).

Figure F:

Place the mouthpiece in your mouth and close your lips around it so you form a good seal.
Breathe in quickly and deeply through your mouth, until your lungs feel completely full of air (see Figure F).

Figure G:

Do not block the vent above the mouthpiece with your lips or fingers (see Figure G).
Remove the inhaler from your mouth.
Hold your breath for about 10 seconds or for as long as you comfortably can.
Your Aermony Respiclick inhaler delivers your dose of medicine as a very fine powder that you may or may not taste or feel. Do not take an extra dose from the inhaler even if you do not taste or feel the medicine.

STEP 3: Close

Figure H:

Close the green cap after inhaling so that the inhaler will be ready for your next dose (see Figure H).
Rinse your mouth with water after taking your dose. Spit out the water. Do not swallow it.
Throw the inhaler away 30 days after you have opened the foil pouch or when the counter reads ‘0,’ whichever comes first.

Cleaning your inhaler:

Never wash or put any part of the inhaler in water.
Gently wipe the mouthpiece with a dry cloth or tissue once a week.

Overdose

If you think you have taken too much Aermony Respiclick, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you have used larger doses than recommended by your doctor for a long period of time, you should talk to your doctor or pharmacist for advice. A gradual reduction of your dose may be needed. Do not stop taking the medication suddenly.

Missed Dose

It is very important that you use Aermony Respiclick regularly; however, if you miss a dose, just skip that dose. Take the next dose at your usual time. Do not take 2 doses at one time.

Side effects and what to do about them

These are not all the possible side affects you may feel when taking Aermony Respiclick. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

headache
feeling anxious
disturbed sleep
behavioural changes (including hyperactivity and irritability)
hoarseness and voice changes, inability to speak
mild yeast infection of the mouth or throat (thrush, Candidiasis) or, rarely, in the esophagus. Common signs are white, slightly raised, sore patches on your tongue and inner cheeks. Remember to rinse and gargle your mouth with water and spit after using Aermony Respiclick. If you wear dentures, cleaning them may also help.
increased bruising
upper respiratory tract infection, viral infections
stuffy/runny nose
cough
fever
sore throat or irritation

Serious side effects and what to do about them
Symptom / effect	Talk to your healthcare professional Only if severe	Talk to your healthcare professional In all cases	Stop taking drug and get immediate medical help
Very Common
Thrush: Yeast infection of the mouth or throat; thick white patches in the mouth, tongue or on the throat, sore throat.		✔
Rare
Allergic Reactions: Lumpy skin rash or hives anywhere on the body.			✔
Churg-Strauss Syndrome: A flu- like illness, rash, pins and needles or numbness of arms or legs, severe sinusitis and worsening lung or breathing problems.		✔
Esophageal candidiasis: Yeast infection of the esophagus (food tube); difficulty swallowing		✔
Very Rare
Slowed growth in children and adolescents.		✔
Cushing’s Syndrome: Round "moon face", rapid weight gain especially around the body. Excess sweating and thinning of the skin with easy bruising and dryness. Muscle and bone weakness.		✔
Bone Fractures or Osteoporosis: In situations where healthy people would not normally break a bone you may have sudden pain in any location and especially in the wrist, spine or hip. This may be a fracture.		✔
Glaucoma: Increased pressure in your eyes, eye pain.		✔
Cataract: Clouding of the lens in the eye, blurry vision, and/or eye pain.		✔
Decreased Adrenal Function: Tiredness, weakness, nausea and vomiting, low blood pressure.		✔
Severe Allergic Reactions: Sudden wheeziness and chest pain or tightness; or swelling of eyelids, face, lips, tongue or throat, difficulty swallowing or breathing.			✔
Hyperglycemia (Increased amount of sugar in blood): Excessive thirst, frequent urination, dry skin, blurred vision and fatigue.		✔
Osteonecrosis: Persistent pain and/or limited range of motion of a joint or a limb.		✔
Unknown
Decreased ability to fight infections. Symptoms of infection may include fever, pain, chills, feeling tired, sore throat.	✔
Worsening of lung symptoms such as wheezing, shortness of breath, cough and chest tightness accompanied by fever and more phlegm.		✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Store Aermony Respiclick at room temperature (between 15oC and 25oC) in a dry place.
Keep the:
- inhaler away from extreme heat, cold, or humidity.
- green cap on the inhaler closed during storage.
- inhaler dry and clean at all times.
Throw the inhaler away 30 days after you have opened the foil pouch or when the counter reads ‘0,’ whichever comes first.
Keep out of the reach and sight of children.

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:

Report online at 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 1908C
  Ottawa, Ontario
  K1A 0K9
- Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about Aermony Respiclick:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website, or by calling 1-855-514-8382.

This leaflet was prepared by Teva Canada Innovation.

Last Revised: December 14, 2018

Aermony RESPICLICK is a trademark of Ivax International B.V., a member of the Teva Group; used under license.

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