How does it work?

Onbrez breezhaler contains the active ingredient indacaterol, which a type of medicine called a long-acting beta ₂agonist.

Indacaterol acts on receptors in the lungs called beta ₂ receptors. It stimulates these receptors and causes the muscles in the airways to relax. This allows the airways to open.

In conditions where there is narrowing of the airways, such as chronic obstructive pulmonary disease (COPD, eg emphysema and chronic bronchitis), it is difficult for air to get in and out of the lungs. By opening the airways, indacaterol makes it easier to breathe.

Indacaterol doesn't open theairways as quickly as short-acting beta ₂ agonists such as salbutamol orterbutaline, however, it does keep the airways open for much longer. Theeffects of indacaterol last for about 24 hours, whereas those of salbutamol orterbutaline last for about 3 to 5 hours. This means indacaterol can be used tohelp keep airways open in people with chronic obstructive pulmonary disease.

Indacaterol is taken using an inhaler device called a breezhaler. Inhaling the medicine allows it to act directly in the lungs where it is needed most. It also reduces the potential for side effects in other parts of the body, as the amount absorbed into the blood through the lungs is lower than if it were taken by mouth.

The Onbrez breezhaler comes with capsules that contain indaceterol powder. One capsule should be inserted into the breezhaler to inhale the medicine. Follow the instructions provided with the breezhaler.

What is it used for?

• Chronic obstructive pulmonary disease (COPD).

Warning!

• Do not exceed the dose of this medicine that your doctor has prescribed you to use.
• Do not swallow the capsules. The powder in the capsules should be inhaled using the breezhaler device provided with your medicine. Follow the instructions provided carefully and talk to your doctor, pharmacist or nurse if you are unsure how to use the device, or have any problems using it. Do not use Onbrez breezhaler capsules with any other inhaler, and do not use Onbrez breezhaler to take any other capsule medicine.
• This inhaler should not be used to relieve sudden attacks of wheezing or breathing difficulties, as it won't work quickly enough. You should keep your reliever inhaler (short-acting bronchodilator, eg salbutamol or terbutaline) with you at all times in case you need to relieve wheezing or shortness of breath.
• If this inhaler does not seem to prevent wheezing or chest tightness as well as usual, or for as long as usual, or if you find you need to use your reliever inhaler (eg salbutamol or terbutaline) more often than normal, you should consult your doctor as soon as possible. It may be that your COPD is getting worse and your doctor might need to give you another medicine.
• Inhalers may cause an unexpected increase in wheezing (paradoxical bronchospasm) straight after using them. If this happens, stop using the inhaler immediately and consult your doctor. The medicine should be stopped and an alternative treatment found.
• People with severe COPD should have regular blood tests to monitor the amount of potassium in their blood. This is because low oxygen levels in the blood (hypoxia) and various COPD medicines, including this one, can lower blood potassium levels.

Use with caution in

• Severe liver disease.
• Diabetes.
• Overactive thyroid gland (thyrotoxicosis).
• Heart disease.
• Abnormal heart rhythms (arrhythmias).
• High blood pressure (hypertension).
• Epilepsy.
• Low blood potassium levels (hypokalaemia).

Not to be used in

• Known sensitivity or allergy to any ingredient, including lactose.
• Children and adolescents under 18 years of age.
• Asthma.
• Breastfeeding.

This medicine should not be used if you are allergic toany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.

If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. Seek medical advice from your doctor.
• It is not known if indacaterol passes into breast milk. This medicine should not be used by breastfeeding mothers. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience that orany side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Headache.
• Inflammation of the nose and throat, causing a blocked or runny nose and sore throat (nasopharyngitis).
• Upper respiratory tract infection.
• Inflammation of the sinuses (sinusitis).
• Sore throat.
• Cough and throat irritation.
• Runny nose or blocked nose.
• High blood glucose level (hyperglycaemia).
• Chest pain (angina). Tell your doctor if you experience this.
• Swelling of the legs and ankles due to excess fluid retention (peripheral oedema).
• Muscle spasms.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Irregular heartbeat caused by very rapid contraction of the top two chambers of the heart (atrial fibrillation).
• Pins and needles sensation (paraesthesia).

The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

This inhaler should not be used in conjunction with any other medicines that contain long-acting beta-agonists, for example salmeterol or formoterol.

This medicine should not usually be used in combination with beta-blocker medicines, such as atenolol, propranolol or timolol. This is because beta-blockers have an opposite action to this medicine and cause the airways to narrow. This can result in breathing difficulties for people with COPD. This problem has sometimes been seen with eye drops containing beta-blockers, eg used for glaucoma.

Indacaterol can potentially cause a decrease in the levels of potassium in the blood (hypokalaemia), which may result in adverse effects. This effect can be increased by the following medicines, which can also lower potassium in the blood:

• xanthine derivates, such as theophylline or aminophylline
• corticosteroids, such as beclometasone and prednisolone
• other beta 2 agonists, such as salbutamol
• diuretics, such as bendroflumethiazide and furosemide.

This is why people with severe COPD, who may be taking several of these medicines, should have their blood potassium levels monitored regularly.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain indacaterol as the active ingredient.