Details for: ANORO ELLIPTA
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02418401 | ANORO ELLIPTA | VILANTEROL (VILANTEROL TRIFENATATE); UMECLIDINIUM (UMECLIDINIUM BROMIDE) | 25 MCG / ACT; 62.5 MCG / ACT | POWDER | INHALATION |
Summary Reports
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
ANORO ELLIPTA is used as a long-term, once a day maintenance treatment. It can make breathing easier for people who experience breathing difficulties (i.e., shortness of breath) due to a lung disease called Chronic Obstructive Pulmonary Disease or COPD (including chronic bronchitis and emphysema).
If you are a smoker, it is important to quit smoking. This will help decrease the symptoms of COPD and potentially increase your lifespan.
What it does
ANORO ELLIPTA is a combination of a long-acting muscarinic antagonist (umeclidinium, a LAMA) and a long-acting beta agonist (vilanterol, a LABA).
ANORO ELLIPTA relaxes the muscles in the walls of small airways in the lungs. The two medicines in ANORO ELLIPTA work together to help open the airways and makes it easier for air to get in and out of the lungs. When taken regularly, ANORO ELLIPTA helps keep the airways open, which can help prevent shortness of breath and wheezing.
There is no cure for COPD, but ANORO ELLIPTA helps to control it. It is therefore important that you continue to take ANORO ELLIPTA regularly even if you feel fine.
When it should not be used
Do not use ANORO ELLIPTA:
- To treat sudden severe symptoms of COPD such as sudden shortness of breath or wheezing. If you experience this sort of attack you must use a rapid onset, short duration, inhaled bronchodilator such as salbutamol (rescue medication). Keep this rescue medication with you at all times.
- To treat asthma.
- If you are allergic to any of the medicinal or nonmedicinal ingredients contained in the product.
- If you have a lactose or severe milk protein allergy.
- If you are younger than 18 years of age.
What the medicinal ingredient is
Umeclidinium and vilanterol.
What the non-medicinal ingredients are
Lactose monohydrate (which contains milk proteins) and magnesium stearate.
What dosage form it comes in
Dry powder for oral inhalation delivered by the ELLIPTA inhaler device. Each dose contains 62.5 mcg umeclidinium and 25 mcg vilanterol per blister.
Each inhaler contains one month’s supply (one dose per day for 30 days).
If a sample is given to you by your doctor, it will contain one week’s supply (one dose per day for 7 days).
Warnings and precautions
Serious Warnings and Precautions
ANORO ELLIPTA should only be used to treat COPD.
ANORO ELLIPTA should not be used to treat asthma.
You are advised that in patients with asthma, long-acting beta2-agonist (LABA) medicines may increase the chance of death from asthma problems. In a large asthma study, more patients who used another LABA medicine (salmeterol) died from asthma problems compared with patients who did not use that LABA medicine. This finding may also apply to ANORO ELLIPTA.
BEFORE you use ANORO ELLIPTA talk to your doctor or pharmacist if you have any of the following:
- Heart problems, such as rapid or irregular heart beat or abnormal electrical signal called “prolongation of the QT interval”
- High blood pressure
- Eye problems such as increased pressure in the eye, or glaucoma
- Prostate or bladder problems, or problems passing urine
- Diabetes
- Seizures
- Thyroid problems
- Any allergies to food or drugs
- Low levels of potassium in your blood
Pregnancy and breast-feeding:
ANORO ELLIPTA is not usually recommended for use during pregnancy.
If you are pregnant, or think you could be, or if you are planning to become pregnant, don’t take ANORO ELLIPTA without asking your doctor. Your doctor will consider the benefit to you and the risk to your unborn baby.
It is not known whether the ingredients of ANORO ELLIPTA can pass into breast milk. If you are breast-feeding, check with your doctor before you take ANORO ELLIPTA.
Driving and Using Machines:
If you experience side effects such as dizziness or blurred vision, you should avoid driving or operating machinery.
COPD flare-up:
ANORO ELLIPTA should not be used to relieve a COPD flare-up. If you experience this sort of attack you must use a rapid onset, short duration, inhaled bronchodilator such as salbutamol (i.e. rescue medication).
If you notice any of the following symptoms, tell your doctor immediately. They could be warning signs that you are having a COPD flare-up or your condition is worsening.
- Unusual increase in the severity of breathlessness, cough, wheezing, or fatigue.
- Unusual colour, amount or thickness of mucus.
- Tightness in the chest or symptoms of a cold.
- You need to use your rescue medication more often than usual.
- Your rescue medication does not work as well to relieve your symptoms.
Short-acting bronchodilators should only be used as rescue medication while you are taking ANOROELLIPTA. Your doctor will instruct you on how to discontinue their regular use when you start taking ANOROELLIPTA
This medication has been prescribed for you and should not be given to other people.
Interactions with this medication
Be sure to tell your doctor or pharmacist:
- About any medicines you are currently taking, or have taken recently, including medications that did not require a prescription, e.g. alternative medicines, vitamins and minerals.
- If you start any new medications.
Drugs that may interact with ANORO ELLIPTA include:
- Other medications that contain a LABA or a short- or long-acting muscarinic antagonist (LAMA) (e.g. ipratropium, tiotropium, glycopyrronium, aclidinium). Ask your doctor or pharmacist if any of your other medicines are LABA or ipratropium or LAMA containing medicines.
- Beta blockers used in the treatment of high blood pressure (e.g., propanolol) or other heart or eye problems (e.g., timolol)
- Ketoconazole (used to treat fungal infections)
- Anti-HIV medicines or clarithromycin
- Medicines used in the treatment of depression (i.e., antidepressants, monoamine oxidase inhibitors)
- Medicines used to decrease the level of potassium in your blood (i.e., diuretics). These are also known as “water pills” and are used to treat high blood pressure.
Proper use of this medication
If you have any difficulties or you are unsure about how or when to take ANORO ELLIPTA, check with your doctor or pharmacist.
One dose of ANORO ELLIPTA lasts a full 24 hours.
Take ANORO ELLIPTA:
- Exactly as recommended by your doctor
- Only once a day
- At the same time each day
- By inhaling it into the lungs through the mouth
Unless you talk to your doctor first, DO NOT:
- Stop taking ANORO ELLIPTA (even if you feel better)
- Use it more frequently than once a day
- Increase the dose
Usual Adult Dose
One inhalation through the mouth once a day.
Taking ANORO ELLIPTA at the same time every day will help you remember to use it.
Overdose
If you accidentally take a larger dose of ANORO ELLIPTA (i.e., more drug than recommended by your doctor), you may feel shaky, have a headache, dry mouth, blurred vision, or feel like your heart is beating faster than usual. Talk to your doctor or pharmacist right away if this occurs.
Missed Dose
If you miss a dose, take your next dose at the usual time the next day. Do not take an extra dose to make up for a missed one.
About your ANORO ELLIPTA Inhaler
Your ELLIPTA inhaler carton contains:
The plastic ELLIPTA inhaler is packaged in a tray, with a peelable foil lid. Do not remove the foil until you are ready to use the inhaler. Peel back the lid to open the tray.
In the tray, you will find a small desiccant sachet containing a drying agent. The dessicant sachet helps to prevent moisture from forming inside the tray. Keep it away from children and pets. Throw away the dessicant sachet once you have opened the lid of the tray. It is dangerous to eat or inhale the contents of the desiccant sachet.
When you take your ELLIPTA inhaler out of its tray it
will be in the closed position. Write the “Discard by”
date on the inhaler label in the space provided. The
“Discard by” date is 6 weeks from the date you open
the tray.
The plastic ELLIPTA inhaler has a light grey body, an
orange mouthpiece cover, and a dose counter. The
mouthpiece and the air vent are hidden by the cover
and can only be seen when the cover is opened. The
ELLIPTA inhaler is ready-to-use. You will not need
to prime it before using it for the first time.
IMPORTANT:
If you open and close the cover of the ELLIPTA inhaler without inhaling the medicine, you will lose a dose. The dose will be securely held inside the inhaler, but it will no longer be available. It is not possible to accidently take extra medicine or take a double dose in one inhalation.
Never try to alter the numbers on the counter or detach the counter on the front of the ELLIPTA inhaler. The counter cannot be reset and is permanently attached to the inhaler.
How to use ARNUITY ELLIPTA:
Please follow the instructions ‘OPEN, INHALE, and CLOSE’ to use your ELLIPTA inhaler. The instructions shown below apply to both the 30-dose and 14-dose ELLIPTA inhaler.
Keep the cover closed until you are ready to inhale a dose. Do not shake the ELLIPTA inhaler at any point during use as this is not necessary.
Sit down or stand in a comfortable position.
OPEN:
Do not shake the ELLIPTA inhaler at any point
during use as this is not necessary.
- When you are ready, activate the inhaler by sliding the orange cover down until you hear a ‘click’ to prepare a dose.
- The dose counter will now count down by one number (“1”). It is unlikely the dose counter will not count down as you hear the ‘click’. If this happens, it may mean the inhaler did not load the medicine. Bring it back to your pharmacist for advice.
- While holding the inhaler away from your mouth, exhale a complete breath (i.e. breathe out as far as is comfortable).Don’t breathe out into the inhaler.
You are now ready to inhale a dose.
INHALE:
- Put the mouthpiece between your lips, and close your lips firmly around it. Do not block the air vent with your fingers or the inhaler mouthpiece with your teeth.
- Take one long, steady, deep breath in. Hold this breath for as long as possible (minimum 3-4 seconds).
CLOSE:
- Remove the inhaler from your mouth. Exhale slowly and gently. Continue to breathe normally.
- You can clean the mouthpiece of the inhaler with a clean dry tissue after you have inhaled the medicine.
- Close the inhaler by sliding the cover upwards as far as it will go to cover the mouthpiece.
You may not be able to taste or feel the medicine (this is normal), even when you are using the inhaler correctly.
Side effects and what to do about them
Side effects may include:
- sore throat (pharyngitis)
- cough
- diarrhea, constipation, stomach pain
- pain in arms and legs, muscle spasms, neck pain, back pain
- headache
- sinus inflammation (sinusitis)
- dry mouth, taste disturbance
- feeling dizzy, tired, unwell
- swollen painful joints
- tremor
- nervousness, feeling anxious
- difficulty sleeping (insomnia)
- nausea, vomiting
- common cold
- hoarseness
ANORO ELLIPTA can cause abnormal blood test results such as decreased levels of potassium and increased blood sugar. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacistin all cases | Stop taking drug and seek immediate medical help |
|---|---|---|---|
| Uncommon | |||
| Pneumonia (infection of the lungs): Fever, chills, increase in sputum production, change in sputum colour, increased cough or an increase in breathing difficulties (shortness of breath, chest pain). | ✔ | ||
| Low Blood Potassium: irregular heartbeats, muscle weakness or spasms and generally feeling unwell | ✔ | ||
| Chest pain | ✔ | ||
| Fast or irregular heartbeat | ✔ | ||
| Allergic Reaction: skin rash, hives, redness, swelling of the face, lips, tongue or throat (angioedema), becoming very wheezy, coughing or difficulty swallowing or breathing, suddenly feeling weak or light headed (may lead to collapse or loss of consciousness). | ✔ | ||
| Rare | |||
| High or Low Blood Pressure: headache, ringing in the ears, lightheadedness, dizziness, fainting | ✔ | ||
| Paradoxical Bronchospasm (worsening of symptoms related to breathing): Tightness of the chest associated with coughing, wheezing, or breathlessness immediately after inhalation of ANORO ELLIPTA | ✔ | ||
| Difficulty urinating or urinary infection: Difficulty and pain when passing urine, urinating frequently, urination in a weak stream or drips | ✔ | ||
| Glaucoma: New or worsened pressure in your eyes, eye pain or discomfort, blurred vision, seeing halos or rainbows around items or red eyes | ✔ | ||
| Unknown | |||
| High Blood Sugar: frequent urination, thirst, and hunger | ✔ | ||
| Heart palpitations: awareness of heartbeat | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ANORO ELLIPTA, contact your doctor or pharmacist.
How to store
- Keep out of sight and reach of children. Your medicine may harm them.
- Keep your inhaler in a cool dry place away from direct heat or sunlight. Keep it closed when not in use.
- Do not store ANORO ELLIPTA in areas above 30°C. If you store in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
- Store in the original package in order to protect from moisture and do not open the foil lid until ready for first use.
- Once the tray is opened:
- You can use the inhaler for up to 6 weeks, starting from the date you opened the lid of the tray.
- Write the date the inhaler should be discarded on the inhaler in the space provided.
- Safely discard ANOROELLIPTA when the dose counter reads “0” or 6 weeks after you open the lid of the tray, whichever comes first. ANORO ELLIPTA expires 6 weeks after you have opened the lid of the tray.
Reporting 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 https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html
- 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 on the MedEffectTM Canada Web site at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html.
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
You may need to read this package insert again. Please do not throw it away until you have finished your medicine.
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.anoro.ca or by contacting the sponsor,
GlaxoSmithKline Inc., at:
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
This leaflet was prepared by GSK Inc.
Last revised: August 9, 2017
©2017 GSK group of companies or its licensor
Trademarks are owned by or licensed to the GSK group of companies