Anoro Ellipta (Umeclidinium Bromide/Vilanterol Trifenatate)

(℞) Prescription Required

    Anoro Ellipta (Umeclidinium Bromide/Vilanterol Trifenatate) Dosage and Side Effects

    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).

    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:

    (See package insert for illustrations.)

    The plastic ELLIPTA inhaler has a light grey body, a red 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.

    Cover: Each time you open this, you prepare one dose of medicine.

    Dose Counter: This shows how many doses of medicine are left in the inhaler.

    Before the inhaler has been used, it shows exactly 30 doses (7 for sample and hospital packs).

    It counts down by 1 each time you open the cover.

    When fewer than 10 doses are left, half of the dose counter shows red.

    After you have inhaled the last dose, half of the dose counter shows red and the number 0 is displayed. Your inhaler is now empty.

    If you open the cover after this, the dose counter will change from half red to completely red.

    The ELLIPTA inhaler is ready-to-use. It does not require you to prime or shake it before use.

    How to use ANORO ELLIPTA:

    Please follow the instructions ‘OPEN, INHALE, and CLOSE’ to use your ELLIPTA inhaler.

    Open:

    How to prepare the ELLIPTA Inhaler for use:

    Do not shake the ELLIPTA inhaler at any point during use as this is not necessary.

    1. When you take your ELLIPTA inhaler out of its tray it will be in the closed position.

    2. Keep the cover closed until you are ready to inhale a dose.

    3. When you are ready, slide the red cover to the side until you hear one ‘click’.

    4. The dose counter will now count down by one number.

    You are now ready to inhale a dose.

    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. Speak to your pharmacist for advice.

    Inhale:

    How to take the medication using the ELLIPTA Inhaler:

    1. Sit down or stand in a comfortable position.

    2. 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.

    3. Put the mouthpiece between your lips, and close your lips firmly around it. Don’t block the air vent with your fingers.

      Your lips fit over the contoured shape of the mouthpiece for inhaling. Don’t block the air vent with your fingers.

    4. Take one long, steady, deep breath in. Hold this breath for as long as possible (minimum 3-4 seconds).

    5. Remove the inhaler from your mouth.

    6. Exhale slowly and gently.

    7. Continue to breathe normally.

    You may not be able to taste or feel the medicine (this is normal), even when you are using the inhaler correctly.

    Safely discard ANORO ELLIPTA when the dose counter reads “0” or 6 weeks after you open the foil lid, whichever comes first.

    How to clean the ELLIPTA Inhaler:

    You can clean the mouthpiece of the inhaler with a clean dry tissue after you have inhaled the medicine.

    Close:

    How to close the ELLIPTA Inhaler:

    Once you have cleaned the ELLIPTA inhaler you should slide the cover upwards as far as it will go to cover the mouthpiece.

    Important:

    Only open the ELLIPTA inhaler when you are ready to take a dose. 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.

    When fewer than 10 doses are left, half of the dose counter shows red, to remind you to refill your prescription. When the counter shows a full solid red background, the ELLIPTA inhaler is empty.

    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.

    Side Effects

    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

    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.

    Warnings and Precautions

    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 ANORO ELLIPTA. Your doctor will instruct you on how to discontinue their regular use when you start taking ANORO ELLIPTA.

    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., propranolol) 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.

    Other related products

    The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.