Details for: PMS-FLUTICASONE HFA
Company: PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02503123 | PMS-FLUTICASONE HFA | FLUTICASONE PROPIONATE | 125 MCG / ACT | METERED-DOSE AEROSOL | INHALATION |
| 02503123 | PMS-FLUTICASONE HFA | FLUTICASONE PROPIONATE | 125 MCG / ACT | METERED-DOSE AEROSOL | ORAL |
| 02503131 | PMS-FLUTICASONE HFA | FLUTICASONE PROPIONATE | 250 MCG / ACT | METERED-DOSE AEROSOL | INHALATION |
| 02503131 | PMS-FLUTICASONE HFA | FLUTICASONE PROPIONATE | 250 MCG / ACT | METERED-DOSE AEROSOL | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
pms-FLUTICASONE helps manage breathing problems in children (4 years 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.
What it does
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.
When it should not be used
- If you are allergic or have had an allergic reaction to fluticasone propionate or any of the ingredients in this medication, including lactose.
- 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.
What the medicinal ingredient is
Medicinal ingredients: fluticasone propionate
What the non-medicinal ingredients are
Non-medicinal ingredients: lactose (milk sugar), and milk protein, which act as the ‘carrier’.
What dosage form it comes in
pms-FLUTICASONE is a dry powder administered through a plastic inhaler device that delivers 100, 250, or 500 mcg of fluticasone propionate per inhalation.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-FLUTICASONE. 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 been told you are allergic to lactose (milk sugar) or milk protein.
- 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: pms-FLUTICASONE 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. pms-FLUTICASONE helps to prevent breathlessness and wheezing from happening due to asthma.
It is very important that you use your medicine regularly as directed by your doctor to control your asthma. pms-FLUTICASONE helps to prevent breathlessness and wheezing from happening due to asthma.
It is very important that you use your medicine regularly as directed by your doctor to control your asthma. pms-FLUTICASONE helps to prevent breathlessness and wheezing from happening due to asthma.
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 pms-FLUTICASONE 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 pms-FLUTICASONE 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 pms-FLUTICASONE.
- You do not feel relief within 10 minutes after using your fast-acting medication or the relief does not last for at least 3 hours.
- You do not feel relief within 10 minutes after using your fast-acting medication or the relief does not last for at least 3 hours.
- 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 pms-FLUTICASONE, 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.
Interactions with this medication
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 pms-FLUTICASONE:
- Ritonavir, a medicine used to treat HIV infection or AIDS
- Medicines used to treat fungal infections, such as ketoconazole
Proper use of this medication
How to take pms-FLUTICASONE:
It is very important that you use 1 inhalation of pms-FLUTICASONE 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 up to a week for this medicine to work and it is very important that you use pmsFLUTICASONE regularly every day. If your shortness of breath or wheeze does not get better in 7 days, tell your doctor. Do not stop taking pms-FLUTICASONE 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 pmsFLUTICASONE more often than your doctor advises. If you have to go into the hospital for an operation, take your pms-FLUTICASONE with you and tell the doctor what medicine(s) you are taking.
The medicine in pms-FLUTICASONE 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 pms-FLUTICASONE. Wait a few minutes after using your inhaled bronchodilator before taking pms-FLUTICASONE.
Usual Dose:
Adults and Adolescents 16 years or older
The usual dose is in the range of 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 4-16 years
The usual dose is 100 micrograms twice daily. For those patients whose asthma is not sufficiently controlled, additional benefit may be obtained by increasing the dose up to 200 micrograms twice daily.
pms-FLUTICASONE should not be used in children under 4 years of age.
When you take your pms-FLUTICASONE out of its box and remove the foil overwrap, it will be in the closed position.
A new powder inhaler contains 60 individually protected doses of your medicine, in powder form. The device has a dose counter which tells you the number of doses remaining. It counts down from 60 to 1. To show when the last five doses have been reached the numbers appear red.
Each dose is accurately measured and hygienically protected. It requires no maintenance, and no refilling.
How to use your pms-FLUTICASONE properly:
It is important that you take each dose as instructed by your doctor, nurse, or pharmacist. Your doctor will decide which strength of pms-FLUTICASONE you should use.
The powder inhaler is easy to use. When you need a dose, just follow the six simple steps illustrated:
1.Open, 2. Slide, 3. Exhale, 4. Inhale, 5. Close, 6. Rinse.
Sliding the lever of your powder inhaler opens a small hole in the mouthpiece and unwraps a dose ready for you to inhale it. When you close the powder inhaler, the lever automatically moves back to its original position ready for your next dose when you need it. The outer case protects your powder inhaler when it is not in use.
1. Open
To open your powder inhaler hold the outer case in one hand and put the thumb of your other hand on the thumb grip. Push the thumb grip away from you, until you hear it click into place.
2. Slide
Hold your powder inhaler with the mouthpiece towards you. Slide the lever away until you hear another click. Your powder inhaler is now ready to use.
Every time the lever is pushed back a dose is made available for inhaling. This is shown by the dose counter. Do not play with the lever as this releases doses which will be wasted.
3. Exhale
Hold the powder inhaler away from your mouth. Breathe out as far as is comfortable. Remember – never exhale into your powder inhaler.
4. Inhale
Before you start to inhale the dose, read through this section carefully. Once you have fully exhaled, place the mouthpiece to your mouth and close your lips around it. Breathe in steadily and deeply through your mouth until a full breath is taken.
Remove the powder inhaler from your mouth. Hold your breath for 10 seconds or as long as is comfortable. Breathe out slowly.
You may not be able to taste or feel the powder on your tongue, even if you have used the powder inhaler correctly.
5. Close
To close your powder inhaler, place your thumb in the thumb grip, and slide it back until you hear a click. The lever is now automatically reset for your next use. The counter on the powder inhaler indicates how many doses are remaining.
6. Rinse
Rinse out your mouth and gargle with water after each dose. Do not swallow the water.
If you have been instructed to take two inhalations you must close the powder inhaler and repeat steps 1 to 4.
Remember
Keep your powder inhaler dry. Keep it closed when not in use. Never exhale into your powder inhaler. Only slide the lever when you are ready to take a dose.
Overdose:
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 pms-FLUTICASONE regularly; however, if you miss a single dose, do not worry - just take the next dose when it is due.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking pms-FLUTICASONE. 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 pmsFLUTICASONE. Cleaning dentures may also help.
- increased bruising
- upper respiratory tract infection, viral infections
- cough
- fever
- sore throat or irritation
| 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. | ✔ | ||
| UNCOMMON | |||
| Allergic Reactions: Lumpy skin rash or hives anywhere on the body. | ✔ | ||
| RARE | |||
| Churg-Strauss Syndrome: A flulike 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. | ✔ | ||
| 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 pmsFLUTICASONE. | ✔ | ||
| 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. | ✔ | ||
| Decreased ability to fight infections. Symptoms of infection may include fever, pain, chills, feeling tired, sore throat. | ✔ | ||
| UNKNOWN | |||
| 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.
How to store
Keep your medicine in a safe place where children cannot reach it. Your medicine may harm them.
Store between 2°C and 30°C in a dry place. Protect from frost and direct sunlight. Do not store in a damp environment such as a bathroom.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
- 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/drugproducts/drug-product-database.html); the manufacturer’s website www.pharmascience.com, or by calling 1-888-550-6060.
This leaflet was prepared by
Pharmascience Inc.
Montréal, Québec
H4P 2T4
Last Revised May 25, 2021