Patient Medication Information: uses, side effects, how to take - Apo-Fluticasone HFA
What is APO-FLUTICASONE HFA used for?
APO-FLUTICASONE HFA helps manage breathing problems in children (12 months and older) and adolescents and adults (aged 16 years and older) who need regular treatment for their asthma.
Asthma is a chronic inflammatory disease of the lungs characterized by episodes of difficulty in breathing. People with asthma have extra sensitive or "twitchy" airways. During an asthma attack the airways react by narrowing, making it more difficult for the air to flow in and out of the lungs.
Control of asthma requires avoiding irritants that cause asthma attacks and taking the appropriate medications. For example, patients should avoid exposure to house dust mites, mold, pets, tobacco smoke and pollens.
How does APO-FLUTICASONE HFA work?
Fluticasone propionate is one of a group of medicines called corticosteroids used to treat breathing problems because they have an anti-inflammatory action. They reduce the swelling and irritation in the walls of the small air passages in the lungs and so ease breathing problems. Corticosteroids also help to prevent attacks of asthma.
What are the ingredients in APO-FLUTICASONE HFA?
Medicinal ingredients: fluticasone propionate.
Non-medicinal ingredients: APO-FLUTICASONE HFA is suspended in a CFC-free propellant, (1, 1, 1, 2 – tetrafluoroethane HFA-134a).
APO-FLUTICASONE HFA comes in the following dosage forms:
APO-FLUTICASONE HFA is a pressurized metered dose inhaler containing 50 mcg, 125 mcg and 250 mcg of fluticasone propionate per inhalation.
Do not use APO-FLUTICASONE HFA:
- If you are allergic or have had an allergic reaction to fluticasone propionate or any of the ingredients in this medication.
- To treat a sudden attack of breathlessness. You will probably need a different kind of medicine in a different colour pack which your doctor may already have given you. If you have more than one medicine, be careful not to confuse them.
If you have an untreated fungal, bacterial or tuberculous infection, unless advised
- by your doctor.
To help avoid side effects and ensure proper use, talk to your healthcare professional
before you take APO-FLUTICASONE HFA. Talk about any health conditions or problems you may have, including if you:
- Have ever had to stop taking other medicines for this illness because you were allergic to them or they caused problems.
- Have ever had a yeast infection (thrush) in your mouth.
- Have a history of tuberculosis (TB) infections.
- Are taking other “steroids” by mouth or inhalation.
- Are suffering from any chest infection (e.g. cold, bronchitis).
- Are suffering from or being treated for diabetes. You may need more frequent blood sugar monitoring or a dosage adjustment of your diabetes medication.
- Have thyroid problems.
Are pregnant, planning to become pregnant or breastfeeding.
- Are taking a medicine called ritonavir, used to treat HIV infection.
- Have liver problems or cirrhosis.
- Have a rare blood disorder called hypoprothrombinemia and are taking acetylsalicylic acid.
Other warnings you should know about:
APO-FLUTICASONE HFA is not for the treatment of acute asthma attacks. A fast acting ‘reliever’ medicine, such as salbutamol (e.g., VENTOLIN), should be used for any sudden attacks of breathlessness or wheezing (e.g., asthma attacks).
It is very important that you use your medicine regularly as directed by your doctor to control your asthma. APO-FLUTICASONE HFA helps to prevent breathlessness and wheezing from happening due to asthma.
You may need to also take steroid tablets or syrup during a severe asthma attack, during other illnesses or during times of stress. Your doctor may give you some steroid tablets or syrup to carry with you as well as a steroid warning card, which will give you advice on when and how to use them.
You should avoid coming into contact with anyone who has measles or the chicken pox while taking inhaled corticosteroids. If you or your child are exposed, tell your doctor right away.
All cortisone-type medicines, especially when used for a long time, may possibly interfere with the usual growth pattern in growing adolescents. You may want to discuss this with your doctor.
When using drugs like APO-FLUTICASONE HFA for long term treatment, you may be at risk of:
- Breaking a bone (bone fractures);
- Osteoporosis (increased risk of bone fractures).
Take extra care to avoid any injury, especially falls.
Drugs like APO-FLUTICASONE HFA can cause eye disorders:
- Cataracts: Clouding of the lens in the eye, blurry vision, eye pain;
- Glaucoma: An increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss;
- Central serous chorioretinopathy (CSCR): blurry vision or other changes in vision.
Contact your healthcare professional if you experience blurry vision or other vision problems.
You should have regular eye exams.
If you notice the following warning signs, you should contact a healthcare professional as soon as possible or go to the nearest hospital.
- A sudden worsening of your shortness of breath and wheezing shortly after using your fast-acting relief medication or after using APO-FLUTICASONE HFA.
- You do not feel relief within 10 minutes after using your fast-acting relief medication or the relief does not last for at least 3 hours.
- Measurement from your peak flow meter indicates a value less than 60 percent of predicted or personal best.
- You are breathless at rest.
- Your pulse is more than 120 beats per minute.
If you experience the following symptoms, inform your doctor immediately as they may indicate that your asthma is getting worse and your treatment may need to be reassessed.
- 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 use increasing amounts of your fast-acting relief medication.
- Measurement from your peak flow meter indicates a value between 60 to 80% of predicted or personal best.
After you start taking APO-FLUTICASONE HFA, your doctor may change the dosages of your other asthma medicines. Rarely, this may make a patient feel worse rather than better. This especially applies to oral corticosteroids, including prednisone. If your doctor decreases your oral steroid dose, and you become unwell, tell your doctor immediately.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-FLUTICASONE HFA:
- Ritonavir, a medicine used to treat HIV infection or AIDS
- Medicines used to treat fungal infections, such as ketoconazole
How to take APO-FLUTICASONE HFA:
It is very important that you use 2 puffs of APO-FLUTICASONE HFA every day, twice a day (even if you have no symptoms), unless otherwise instructed by your doctor. This will help you to keep free of symptoms throughout the day and night.
It may take several days for this medicine to work and it is very important that you use APO-FLUTICASONE HFA regularly every day. If your shortness of breath or wheeze does not get better in 7 days, tell your doctor.
Do not stop taking APO-FLUTICASONE HFA suddenly – even if you feel better. Your doctor can provide you with information about how to slowly stop the medication if necessary. If your doctor decides to stop treatment, do not keep any left-over medicine unless your doctor tells you to. Do not take more doses or use your inhaler more often than your doctor advises. If you have to go into the hospital for an operation, take your inhaler with you and tell the doctor what medicine(s) you are taking.
The medicine in APO-FLUTICASONE HFA must not be swallowed and should only be inhaled.
If you are also using a rapid onset, short duration, inhaled bronchodilator such as salbutamol (e.g., VENTOLIN), use your inhaled bronchodilator before using APO-FLUTICASONE HFA. Wait a few minutes after using your inhaled bronchodilator before taking APO-FLUTICASONE HFA.
Talk to your doctor before using APO-FLUTICASONE HFA with a spacer device (holding chamber) because your dose may need to be changed.
Usual dose:
Adults and Adolescents 16 years or older
The usual dose is 100 to 500 micrograms twice daily. Patients with very severe asthma, requiring higher doses of corticosteroids such as those patients currently requiring oral steroids may use doses up to 1000 micrograms twice daily.
Children 4 to 16 years
The usual dose for APO-FLUTICASONE HFA is 100 micrograms twice daily.
Children 12 months to 4 years
The usual dose is 100 micrograms twice daily, administered via a pediatric spacer device with a face mask.
Spacer devices (holding chambers) may be used in patients who have difficulty coordinating the actuation of a metered dose inhaler with inhalation. Talk to your doctor before using APO-FLUTICASONE HFA with a spacer device because your dose may need to be changed. If using a spacer device, follow the instructions of the device’s manufacturer.
APO-FLUTICASONE HFA should not be used in children less than 12 months of age.
How to Prime APO-FLUTICASONE HFA:
Before you use your APO-FLUTICASONE HFA for the first time, or if your inhaler has not been used for a week or more, it must be primed. Remove the mouthpiece cover, shake the inhaler well for 5 seconds and with the inhaler pointing away from your face, release one puff into the air. Shake again for 5 seconds and release a second puff into the air. Priming helps ensure that APO-FLUTICASONE HFA is working properly and delivering the correct dose of medicine to you.
How to use your APO-FLUTICASONE HFA properly:
It is important that you take each dose as instructed by your doctor, nurse, or pharmacist. Your doctor will decide which strength of APO-FLUTICASONE HFA you should use.
Use APO-FLUTICASONE HFA only with the actuator supplied with the product. Discard canister after 120 sprays for the 120 dose canister.
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Each prescribed dose is usually given by a minimum of 2 puffs. Before taking your next puff, hold the inhaler upright and wait 30 seconds before repeating steps 2 through 4.
To keep out dust and lint, replace the mouthpiece cover by firmly pushing and snapping the cover into position. Do not use excessive force. Always store your inhaler with the mouthpiece pointing down.
Important
Do not rush step 4. It is important that you start to breathe in as slowly as possible just before operating your inhaler. Practice in front of a mirror for the first few times. If you see "mist" coming from the top of your inhaler or the sides of your mouth, you should start again from step 2.
If your doctor has given you different instructions for using your inhaler, please follow them carefully. Tell your doctor if you have any difficulties.
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Children/Elderly:
Some patients may need help and an adult may need to operate the inhaler for them. Encourage the patient to breathe out and operate the inhaler immediately as the patient starts to breathe in. Practice the technique together. Children or people with weak hands should hold the inhaler with both hands. Put the two forefingers on top of the inhaler and both thumbs on the base below the mouthpiece.
If using a spacer device, follow the manufacturer’s instructions.
Cleaning:
To prevent your inhaler from blocking up, it is important to clean it at least once a week, following the instructions below. If your inhaler does block up, the same cleaning instructions should be followed. If you notice a build-up of medicine around the mouthpiece, do not attempt to unblock it with a sharp object, such as a pin.
To clean your inhaler:
- 1. Remove the mouthpiece cover.
- 2. Do not remove the canister from the plastic casing.
- 3. Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth, tissue or cotton swab. Do not put the metal canister into water.
- 4. Replace the mouthpiece cover.
- 5. After cleaning, release one puff into the air to make sure that the inhaler works.
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-FLUTICASONE HFA, contact a 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 APO-FLUTICASONE HFA regularly; however, if you miss a single dose, do not worry - just take the next dose when it is due.
What are possible side effects from using APO-FLUTICASONE HFA?
These are not all the possible side effects you may feel when taking APO-FLUTICASONE HFA. 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 APO-FLUTICASONE HFA. Cleaning dentures 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 | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Thrush: Yeast infection of the mouth or throat; thick white patches in the mouth, tongue or on the throat, sore throat. | √ | ||
| UNCOMMON | |||
| Allergic Reactions: Lumpy skin rash or hives anywhere on the body. | √ | ||
| RARE | |||
| 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. | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| 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. | √ | ||
| Allergic Reactions: Sudden wheeziness and chest pain or tightness; or swelling of eyelids, face, lips, tongue or throat, difficulty swallowing or breathing. | √ | ||
Bronchospasm: Sudden worsening of shortness of breath and wheezing shortly after using APO-FLUTICASONE HFA. | √ | ||
| 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. | √ | ||
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.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
Storage:
Keep your medicine in a safe place where children cannot reach it. Your medicine may harm them.
After use, replace the mouthpiece cover firmly and snap it into position. Do not use excessive force.
Store APO-FLUTICASONE HFA at room temperature (15°C to 30°C) with the mouthpiece pointing down. Protect from frost and direct sunlight.
As with most inhaled medications in pressurized canisters, the effect of this medication may decrease when the canister is cold. If the inhaler becomes very cold, remove the metal canister and warm it in your hand for a few minutes. Never use other forms of heat.
Warning – The metal canister is pressurized. Do not puncture it, even when you think it is empty.
If you want more information about APO-FLUTICASONE HFA:
- 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html). Find the Patient Medication Information on the manufacturer’s website (http://www.apotex.ca/products) or by calling 1-800-667-4708.
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