Indacaterol + Glycopyrronium bromide - Inhalation

Indacaterol and Glycopyrronium bromide are combined in this medicine.

Indacaterol + Glycopyrronium bromide is used to treat chronic obstructive pulmonary disease (a long-term lung disease that causes airflow obstruction making it hard to breathe).

Use Indacaterol + Glycopyrronium bromide exactly as directed by your doctor or according to the instructions on the label. Do not use more or less than instructed by your doctor.

This medicine is available as a capsule for inhalation, where an inhaler device will be used. Do not swallow the capsule.

To take a dose, follow these steps:

1. Pull off the cap of the inhaler, then open the inhaler by holding the base of the inhaler firmly and tilting the mouthpiece.
2. Take the capsule out from the blister pack (remove the capsule only before use). Do not leave the capsule exposed to air for too long.
3. Place the capsule inside the centre chamber of the inhaler. Close the mouthpiece firmly until you hear a clicking sound.
4. Hold the inhaler with the mouthpiece facing upwards.
5. Pierce the capsule by pressing the side buttons (located at the base of the inhaler) at the same time. You should hear a noise as the capsule is being pierced, then release the side buttons fully. Only pierce the capsule once.
6. Breathe out completely.
7. Place the inhaler in your mouth and close your lips firmly around the mouthpiece.
8. Breathe in quickly but steadily and as deeply as you can. As you breathe in, you should hear or feel the capsule vibrate.
9. Hold your breath for up to 5 seconds. At the same time, remove the inhaler from your mouth.
10. Open the inhaler and check if the capsule is empty. If there is powder left in the capsule, repeat steps 6-9. This will ensure you receive the full dose.

Make sure you know how to use your inhaler. If you have problems or do not understand the instructions, ask your doctor or pharmacist.

Do not share your inhaler with others as it could spread infection.

Indacaterol + Glycopyrronium bromide must be used regularly for it to be effective. Continue using this medicine even when you feel better. Do not stop using it unless instructed by the doctor.

Use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose to make up for a missed dose.

If you often forget to use your medicine, let your doctor and pharmacist know.

Inform your doctor if you have the following conditions:

• increased pressure in the eye
• urinary retention (inability to completely empty the bladder when urinating)
• heart disease or blood vessel problems e.g. narrowing of the blood vessels of the heart, history of heart attack, heart rhythm problems, increased blood pressure
• diabetes
• hyperthyroidism (overactive thyroid gland)
• hypokalaemia (low potassium level in the blood)
• epilepsy (fits or seizures)
• severe liver disease
• severe kidney disease

Let your doctor know if you are pregnant or breastfeeding.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Routine tests (e.g. lung function, blood sugar levels) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Your blood pressure may rise to unsafe levels without you noticing it. Monitor your blood pressure regularly during treatment.
• Regular monitoring of signs and symptoms of increased eye pressure, allergic reactions and urinary retention may also be needed.

Indacaterol + Glycopyrronium bromide may cause any of the following side effects: headache, dizziness, indigestion, tooth decay, and fever.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• signs and symptoms of breathing problems e.g. difficulty breathing or worsening of breathing, wheezing, cough
• signs and symptoms of allergic reaction e.g. rashes, breathlessness, swelling of the face, eyes or mouth
• muscle weakness, cramping or pain; irregular heartbeat
• pain or tightness in your chest, fast or abnormal heartbeat

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Inform your doctor and pharmacist if you are taking any of these medicines:

• other similar medicines for breathing problems e.g. salmeterol, ipratropium bromide
• certain medicines for high blood pressure e.g. propranolol
• water pills or medicines for water retention e.g. hydrochlorothiazide
• steroids (anti-inflammatory medicines) e.g. prednisolone

This list does not include all medicines that may interact with Indacaterol + Glycopyrronium bromide.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Store in a cool, dry place away from the reach of children.

Protect from moisture.

Medicines must not be used past the expiry date.