Consumer medicine information

Incruse Ellipta 62.5 mcg/actuation Powder for inhalation

Umeclidinium

BRAND INFORMATION

Brand name

Incruse Ellipta

Active ingredient

Umeclidinium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Incruse Ellipta 62.5 mcg/actuation Powder for inhalation.

1. Why am I using INCRUSE ELLIPTA?


INCRUSE ELLIPTA contains the active ingredient umeclidinium. INCRUSE ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD).
For more information, see Section 1. Why am I using INCRUSE ELLIPTA? in the full CMI.

2. What should I know before I use INCRUSE ELLIPTA?


Do not use if you have ever had an allergic reaction to INCRUSE ELLIPTA or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use INCRUSE ELLIPTA? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with INCRUSE ELLIPTA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use INCRUSE ELLIPTA?

  • The usual dose of INCRUSE ELLIPTA for COPD is one inhalation daily at the same time.

More instructions can be found in Section 4. How do I use INCRUSE ELLIPTA? in the full CMI.

5. What should I know while using INCRUSE ELLIPTA?

Things you should do
  • Remind any doctor, dentist, pharmacist or nurse you visit that you are using INCRUSE ELLIPTA.
  • Tell your doctor immediately if you become pregnant or intend to become pregnant whilst using INCRUSE ELLIPTA.
  • Tell your doctor if you feel you are getting breathless or wheezy more often than normal, or if you are using your quick-acting inhaler more than usual.
Things you should not do
  • Do not stop using this medicine suddenly or lower the dosage without checking with your doctor.
  • Do not take any other medicines to help you breathe without first checking with your doctor.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how INCRUSE ELLIPTA affects you.
Looking after your medicine
  • Store it in a cool dry place (below 30°C) away from moisture, heat or sunlight.
  • If you store it in the refrigerator allow the inhaler to return to room temperature at least 1 hour before you use it.
  • Safely throw away INCRUSE ELLIPTA six weeks after you open the foil tray or when the counter reads 0, whichever comes first.

For more information, see Section 5. What should I know while using INCRUSE ELLIPTA? in the full CMI.

6. Are there any side effects?


Side effects that have been reported include painful and frequent urination (may be signs of a urinary tract infection), feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis), combination of sore throat and runny nose, faster heartbeat, cough, infection of the upper airways, taste disturbance.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Incruse Ellipta

Active ingredient

Umeclidinium

Schedule

S4

 

1 Name of Medicine

Umeclidinium (as bromide).

2 Qualitative and Quantitative Composition

Moulded plastic device containing one foil strip of either 7 or 30 regularly distributed blisters, each containing a white powder. Each delivered dose (the dose leaving the mouthpiece of the inhaler) contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide). This corresponds to a pre-dispensed dose of 62.5 micrograms of umeclidinium (equivalent to 74.2 micrograms umeclidinium bromide).
Umeclidinium bromide is slightly soluble in water and slightly soluble in methanol, ethanol, acetonitrile and propan-1-ol.
List of excipients with known effect. Lactose monohydrate (which contains milk protein).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for inhalation.

4 Clinical Particulars

4.9 Overdose

No data from clinical studies are available regarding overdose with Incruse Ellipta.
Symptoms and signs. An overdose of Incruse Ellipta will likely produce signs and symptoms consistent with the known inhaled muscarinic antagonist adverse effects (e.g. dry mouth, visual accommodation disturbances and tachycardia).
Treatment. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Umeclidinium was not genotoxic in a standard battery of studies, comprising bacterial mutation assays, the mouse lymphoma tk assay and the rat bone marrow micronucleus test.
Carcinogenicity. Umeclidinium was not carcinogenic in 2 year inhalation studies in mice or rats at doses yielding systemic exposure levels (plasma AUC) up to 26 or 22 times the human clinical exposure of umeclidinium at the maximum recommended dose of 62.5 microgram per day in the respective species.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical name. The chemical name of umeclidinium bromide is 1-azoniabicyclo[2.2.2]octane, 4-(hydroxydiphenylmethyl)- 1-[2-(phenylmethoxy)ethyl]-, bromide (1:1).
Chemical formula. Umeclidinium bromide: C29H34BrNO2.
Chemical structure. Umeclidinium bromide:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSUMEBRO.gif CAS number. Umeclidinium bromide: 869113-09-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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