Ultibro breezhaler

How do I use Ultibro breezhaler?

• Ultibro breezhaler comes with capsules that contain the medicine in powder form. These capsules are put in the chamber in the inhaler. You then use the inhaler to pierce the capsule and breathe in the powder. Do not swallow the capsules.
• It is important to follow the instructions provided with the breezhaler carefully, and talk to your doctor, pharmacist or nurse if you are unsure how to use the device, or have any problems using it.
• The usual dose of Ultibro is one capsule to be inhaled once daily. The daily dose should be taken at the same time each day. The effect of the medicine lasts for 24 hours.
• If you forget to take your dose at your usual time, then take it as soon as you remember that day. Then take your next dose at your usual time the following day. If you forget to take a dose for a whole day then just leave out the missed dose. Do not take more than one dose in a day to make up for a missed dose.
• You should not suddenly stop using this inhaler, even if you don't currently have any symptoms, unless your doctor tells you otherwise. This is because stopping treatment is likely to make your symptoms come back.
• Do not exceed the recommended dose of this medicine.
• Each Ultibro breezhaler should be disposed of after 30 days of use, preferably by returning it to your pharmacy.

Important information about Ultibro breezhaler

• Do not swallow the capsules. Make sure you follow the instructions provided with your Ultibro breezhaler. These tell you how to put a capsule in the inhaler, how to pierce the capsule with the inhaler and how to breathe in the medicine using the inhaler, as well as how to clean the inhaler and various other pieces of information. Do not use Ultibro breezhaler capsules with any other inhaler, and do not use Ultibro breezhaler to take any other capsule medicine.
• Ultibro should not be used to relieve an attack of breathing difficulty. Instead, it should be used regularly each day to keep the airways open and help prevent breathing difficulties. 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.
• This medicine can cause a dry mouth, which may increase the risk of tooth decay with long-term use of the medicine. It is therefore important to practise good oral hygiene and visit your dentist regularly for check-ups.
• 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.

Ultibro breezhaler should be used with caution by

• People with severely decreased kidney function or kidney failure needing dialysis.
• People with severely decreased liver function.
• People who have difficulty passing urine, for example men with an enlarged prostate gland or people with an obstruction of the bladder.
• People with closed angle glaucoma.
• People with a history of heart disease, such as heart failure, heart attack, angina or irregular heartbeats (arrhythmias).
• People with diabetes.
• People with epilepsy.
• People with an overactive thyroid gland (thyrotoxicosis).

Ultibro breezhaler should not be used by

• People with asthma.
• Children and adolescents under 18 years of age.

The capsules used in Ultibro breezhaler contain lactose. This medicine should not be used by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

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

The safety of this medicine for use during pregnancy has not been established. It should therefore be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the unborn baby. Seek medical advice from your doctor.
It is not known if indacaterol and glycopyrronium pass into breast milk after inhalation. You should seek medical advice from your doctor before breastfeeding while using this medicine.
Possible side effects of Ultibro breezhaler

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common 

• Upper respiratory tract infections such as cough and cold.

Common 

• Inflammation of the sinuses (sinusitis).
• Nasal inflammation, causing a blocked or runny nose (rhinitis).
• Cough, throat irritation or sore throat.
• Dizziness.
• Headache.
• Indigestion.
• Infection of the stomach and bowel (gastroenteritis).
• Urinary tract infection or cystitis.
• Chest pain (angina). Tell your doctor if you experience this.
• Fever.
• Tooth decay.

Uncommon

• Allergic reactions such as swelling of the face, throat and tongue (angioedema). Stop using this inhaler and consult your doctor straight away if you experience this.
• Increased blood sugar levels (hyperglycaemia).
• Difficulty sleeping (insomnia).
• Pins and needles sensations (paraesthesia).
• Glaucoma (raised pressure in the eye).
• Nosebleeds.
• Irregular heartbeat (atrial fibrillation).
• Faster than normal heartbeat (tachycardia).
• Awareness of your heartbeat (heart palpitations).
• Dry mouth.
• Skin reaction such as itching and rash.
• Spasms or pain in the muscles (myalgia).
• Pain in the hands and feet.
• Obstruction to the outflow of urine from the bladder and difficulty passing urine (urinary retention).
• Swelling of the ankles and feet (peripheral oedema).
• Feeling weak or fatigued.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

How can Ultibro breezhaler affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination 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.

This medicine has not been studied in combination with other anticholinergic medicines such as those below, and these are therefore not recommended while you are using this medicine:

• aclidinium
• ipratropium
• oxitropium
• tiotropium.

If you experience a dry mouth as a side effect of this medicine you may find that medicines that are designed to dissolve and be absorbed from under the tongue, eg sublingual glyceryl trinitrate (GTN) tablets for angina, become less effective. This is because the tablets do not dissolve properly in a dry mouth. To resolve this, drink a mouthful of water before taking sublingual tablets.

References:

https://www.nps.org.au/medical-info/medicine-finder/brimica-genuair-340-12-oral-inhalation

http://www.netdoctor.co.uk/medicines/lungs/a8949/ultibro-breezhaler-indacaterol-glycopyrronium/

http://www.medicines.ie/medicine/16347/SPC/Brimica+Genuair+340+micrograms++12+micrograms+inhalation+powder/#MACHINEOPS

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003969/human_med_001806.jsp&mid=WC0b01ac058001d124