Onbrez Breezhaler (Indacaterol)

Serious Warnings and Precautions

ONBREZ BREEZHALER should only be used to treat COPD.

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 ONBREZ BREEZHALER.

BEFORE you use ONBREZ BREEZHALER talk to your doctor or pharmacist if you:

• have heart problems, such as rapid or irregular heart beat or abnormal electrical signal called “prolongation of the QT interval”
• have high blood pressure
• have epilepsy
• have thyroid gland problems
• have diabetes
• are pregnant or planning to become pregnant. It is not known if ONBREZ BREEZHALER may affect your unborn baby
• are breastfeeding. It is not known if ONBREZ BREEZHALER passes into your milk and if it can affect your baby
• are taking certain medications
• ONBREZ BREEZHALER contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in patients who have a severe milk protein allergy.

During the treatment with ONBREZ BREEZHALER, tell your doctor immediately if you experience any of the following symptoms:

• If you experience a tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation (signs of bronchospasm)
• If you experience difficulties in breathing or swallowing, swelling of tongue, lips and face, hives or itching, skin rash (signs of hypersensitivity reaction). Do not use ONBREZ BREEZHALER again before speaking with your doctor.
• If your COPD symptoms (breathlessness, wheezing, cough) do not improve or if they worsen during your treatment

ONBREZ BREEZHALER does not relieve sudden symptoms of COPD. Always have a short-acting bronchodilator medicine with you to treat acute symptoms. If you do not have an inhaled, short-acting bronchodilator, contact your healthcare provider to have one prescribed for you.

Get emergency medical care if:

• breathing problems worsen quickly
• you use your short-acting bronchodilator medicine, but it does not relieve your breathing problems

Like all medicines, ONBREZ BREEZHALER can cause side effects in some people.

Some people occasionally cough soon after inhaling the medicine. If you do, don't worry, as long as the capsule is empty, you have received the full dose.

Common side effects include:

• Nausea
• Upper respiratory tract infections
• Muscle cramp
• Headache
• Cough
• Irritation of the mouth or throat

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Tell your doctor or a pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes in particular the following medicines:

• medicines used in the treatment of depression or sad mood (e.g. tricyclic antidepressants, monoamine oxidase inhibitors)
• medicines similar to ONBREZ BREEZHALER (other LABA) used for your lung disease as it may increase the risk of experiencing possible side effects
• medicines that decrease the level of potassium in your blood. These include diuretics (also known as “water pills” and used to treat hypertension e.g. hydrochlorothiazide), other bronchodilators such as methylxanthines (e.g. theophylline) or steroids (e.g. prednisolone)
• beta-blockers used in the treatment of hypertension or other cardiac problems (e.g. propranolol) or in the treatment of glaucoma (e.g. timolol)

Follow your doctor's instructions carefully. Do not exceed the recommended dose.

Usual adult dose:

Inhale the contents of one capsule through the mouth each day, everyday at the same time, using the ONBREZ BREEZHALER inhalation device, even when you have no breathing problems or other symptoms of COPD.

You may inhale this medication in a fasting state or after food or drink.

How to inhale ONBREZ BREEZHALER:

Follow the instructions below. You will breathe in (inhale) the medicine in the ONBREZ BREEZHALER capsules from the ONBREZBREEZHALER inhalation device. If you have any questions, ask your healthcare provider or pharmacist.

The ONBREZ BREEZHALER package contains ONBREZ BREEZHALER capsules and one ONBREZ BREEZHALER inhalation device.

• The ONBREZ BREEZHALER capsules are supplied in one or more blister cards. Each blister card contains 10 transparent capsules.
• The ONBREZ BREEZHALER inhalation device consists of a cap and a base.

Your inhalation device is designed to deliver the medicine contained in the capsules. Do not use ONBREZ BREEZHALER capsules with any other capsule inhalation device, and do not use the ONBREZ BREEZHALER inhalation device to take any other capsule medicine.

1. Pull off the cap
2. Open inhalation device:
3. Hold the base of the ONBREZ BREEZHALER inhalation device firmly and tilt the mouthpiece to open the inhalation device.
4. Prepare capsule:
5. Immediately before use, with dry hands, remove one capsule from the blister.
6. Insert capsule:
7. Place the capsule into the capsule chamber.
8. Never place a capsule directly into the mouthpiece.
9. Close the inhalation device:
10. Close the inhalation device fully. You should hear a ‘click' as it fully closes.
11. Pierce the capsule:
12. Hold the inhalation device upright with the mouthpiece pointing up. Press both buttons fully one time. You should hear a ‘click' as the capsule is being pierced. Do not press the piercing buttons more than once.
13. Release the buttons fully.
14. Breathe out:
15. Before placing the mouthpiece in your mouth, breathe out fully.
16. Never blow into the mouthpiece.
17. Inhale the medicine:
18. Before breathing in, place the mouthpiece in your mouth and close your lips firmly around the mouthpiece. Hold the inhalation device with the buttons to the left and right (not up and down). Breathe in rapidly but steadily, as deeply as you can. Do not press the piercing buttons.
19. Note:
20. As you breathe in through the inhalation device, the capsule spins around in the chamber and you should hear a whirring noise. You will experience a sweet taste as the medicine goes into your lungs. If you do not hear a whirring noise, the capsule may be stuck in the capsule cavity. If this occurs, open the inhalation device and carefully loosen the capsule by tapping the base of the device. Do not press the piercing buttons to loosen the capsule. Repeat steps 8 and 9 if necessary.
21. Hold breath:
22. Continue to hold your breath for at least 5-10 seconds or as long as comfortably possible while removing the inhalation device from your mouth. Then breathe out.
23. Open the inhalation device to see if any powder is left in the capsule. If there is powder left in the capsule, close the inhalation device and repeat steps 8 to 11. Most people are able to empty the capsule with one or two inhalations. Some people occasionally cough soon after inhaling the medicine. If you do, don't worry, as long as the capsule is empty, you have received the full dose.
24. Remove capsule:
25. After you have finished taking your daily dose of ONBREZ BREEZHALER, open the mouthpiece again, remove the empty capsule by tipping it out, and discard it. Close the inhalation device and replace the cap.
26. Do not store the capsules in the ONBREZ BREEZHALER inhalation device.
27. Mark daily dose tracker:
28. On the inside of the pack there is a daily dose tracker. Put a mark in today's box if it helps to remind you of when your next dose is due.

Additional Information:

Occasionally, very small pieces of the capsule can get past the screen and enter your mouth. If this happens, you may be able to feel these pieces on your tongue. It is not harmful if these pieces are swallowed or inhaled. The chances of the capsule shattering will be increased if the capsule is pierced more than once (Step 6).

Remember:

• Do not swallow ONBREZ BREEZHALER capsules
• Only use the ONBREZ BREEZHALER inhalation device contained in this pack
• ONBREZ BREEZHALER capsules must always be stored in the blister, and only removed immediately before use
• Never place an ONBREZ BREEZHALER capsule directly into the mouthpiece of the ONBREZ BREEZHALER inhalation device
• Do not press the piercing buttons more than once
• Never blow into the mouthpiece of the ONBREZ BREEZHALER inhalation device
• Always release the push buttons before inhalation
• Never wash the ONBREZ BREEZHALER inhalation device with water. Keep it dry
• Never take the ONBREZ BREEZHALER inhalation device apart
• Always use the new ONBREZ BREEZHALER inhalation device that comes with your new ONBREZ BREEZHALER medication pack (use a new ONBREZ BREEZHALER inhalation device each month)
• Do not store the capsules in the ONBREZ BREEZHALER inhalation device
• Always keep the ONBREZ BREEZHALER inhalation device and ONBREZ BREEZHALER capsules in a dry place

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 have accidentally inhaled too much ONBREZ BREEZHALER or if someone else accidentally inhaled your medicine, contact a doctor or hospital for advice immediately.

Show the pack of ONBREZ BREEZHALER. Medical attention may be needed.

Missed dose:

If you forget a dose, inhale the next dose on the usual time the next day. Do not take a double dose to make up for a forgotten dose.