Ultibro Breezhaler® Capsules

The active substances are indacaterol maleate and glycopyrronium bromide. Each capsule contains indacaterol maleate equivalent to 110 micrograms indacaterol and glycopyrronium bromide equivalent to 50 micrograms glycopyrronium. The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 85 micrograms indacaterol and 43 micrograms glycopyrronium. Contains sugar: Lactose ULTIBRO BREEZHALER is used to make breathing easier for people who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD) and who have not adequately responded to current treatment. If you have any questions about how ULTIBRO BREEZHALER works or why this medicine has been prescribed for you, ask your doctor. Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet.

Do not use ULTIBRO BREEZHALER if you have ever had an unusual or allergic reaction to the active ingredients, indacaterol and glycopyrronium, lactose or to any other ingredients of this product listed in section 6. If this applies to you, tell your doctor without using ULTIBRO BREEZHALER. If you think you may be allergic, ask your doctor for advice.

Take special care with ULTIBRO BREEZHALER Before using ULTIBRO BREEZHALER, tell your doctor if any of the following applies to you:

• if you are an asthmatic (in this case you should not be treated with ULTIBRO BREEZHALER)
• if you have heart problems
• if you suffer from epilepsy
• if you have thyroid gland problems
• if you suffer from diabetes
• if you are taking similar medicines for your lung disease (see “Using other medicines with ULTIBRO BREEZHALER”)
• you have kidney problems
• you have an eye problem called narrow-angle glaucoma
• you have difficulty passing urine

ULTIBRO BREEZHALER is used as a maintenance treatment for your COPD. Do not use ULTIBRO BREEZHALER to treat a sudden attack of breathlessness or wheezing.

Do not share medicines prescribed for you with any other person. Always use ULTIBRO BREEZHALER exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much ULTIBRO BREEZHALER to inhale The usual dose is to inhale the content of one capsule each day. Do not use more than your doctor tells you to use.

When to inhale ULTIBRO BREEZHALER You only need to inhale once a day to help you breathe easier because ULTIBRO BREEZHALER lasts for 24 hours. Inhaling ULTIBRO BREEZHALER at the same time each day will help to minimise your symptoms throughout the day and night and will also help you to remember to use it.

How to inhale ULTIBRO BREEZHALER In this pack, you will find an inhaler and capsules (in blister strips) that contain the medicine as inhalation powder.

• Only use the inhaler contained in this pack (ULTIBRO BREEZHALER inhaler) to inhale the powder in a capsule.
• Do not swallow the capsules.
• Capsules should always be stored in the blister strip and only removed immediately before use.
• When you start a new pack, use the new ULTIBRO BREEZHALER inhaler supplied in this new pack.
• Dispose of each inhaler after 30 days of use.

ULTIBRO BREEZHALER can have side effects. Not all side effects reported for ULTIBRO BREEZHALER are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ULTIBRO BREEZHALER, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens stop taking ULTIBRO BREEZHALER and tell your doctor immediately or go to the casualty department at your nearest hospital:

• If you experience a tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation of ULTIBRO BREEZHALER (signs of bronchospasm)
• If you experience an irregular or fast heart beat (possible signs of atrial fibrillation or Tachycardia)
• If you experience difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash (signs of hypersensitivity reaction)
• If your COPD symptoms (breathlessness, wheezing, cough) do not improve or if they worsen during your treatment
• If you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes; these may be signs of an acute attack of narrow-angle glaucoma.
• High level of blood sugar (hyperglycaemia; typical symptoms include excessive thirst or hunger and frequent urination)

These are all very serious effects, which may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• Frequent: Blocked nose, sneezing, coughing, headache with or without fever (signs of upper respiratory tract infection).
• Urinary tract infection: painful and frequent urination (signs of cystitis)
• Dizziness
• Cough
• Sore throat
• Upset stomach, indigestion
• Cavities
• Pain in muscles, bones or joints
• Fever
• Chest pain

Store at or below 25 °C and protect from moisture.

ULTIBRO BREEZHALER capsules must always be stored in the blister to protect from moisture and only removed immediately before use.

Do not store the medicine in the bathroom and or in the sun.

KEEP ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN.

Do not use the capsules after the expiry date printed on the blister or label.

Each inhaler should be disposed of after 30 days.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).