Incruse Ellipta (Umeclidinium Bromide)

If you have any difficulties or you are unsure about how or when to take INCRUSE ELLIPTA, check with your doctor or pharmacist.

One dose of INCRUSE ELLIPTA lasts a full 24 hours.

Take INCRUSE 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 INCRUSE 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 INCRUSE ELLIPTA at the same time every day will help you remember to use it.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you accidentally take a larger dose of INCRUSE ELLIPTA (i.e., more drug than recommended by your doctor), you may 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.

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

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

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 may include:

• cough
• diarrhea, stomach pain
• constipation
• pain in arms and legs, neck pain, back pain
• headache
• sinus inflammation (sinusitis), runny nose, sore throat
• dry mouth, toothache, taste disturbance
• feeling dizzy
• joint pain, muscle pain
• nausea
• depression
• common cold
• bruising

BEFORE you use INCRUSE ELLIPTA talk to your doctor or pharmacist if you have any of the following:

• Heart problems.
• Eye problems such as increased pressure in the eye, or glaucoma.
• Prostate or bladder problems, or problems passing urine.
• Any allergies to food or drugs.

Pregnancy and breast-feeding:

INCRUSE 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 INCRUSE 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 INCRUSE ELLIPTA can pass into breast milk. If you are breast-feeding, check with your doctor before you take INCRUSE 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:

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

This medication has been prescribed for you and should not be given to other people.

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 INCRUSE ELLIPTA include:

• Other medications that contain a short- or long-acting muscarinic antagonist (e.g., ipratropium, tiotropium, glycopyrronium, aclidinium). Ask your doctor or pharmacist if any of your other medicines are ipratropium or LAMA containing medicines.