What is it used for?

• Asthma in adults and adolescents aged 12 years and over.
• Relvar ellipta inhaler is used to treat people whose asthma is not controlled with regular corticosteroids and as needed short-acting bronchodilators (relievers, eg salbutamol).
• Relvar ellipta inhaler should be used regularly to prevent asthma attacks (maintenance therapy), with a separate reliever inhaler (eg salbutamol) used to relieve asthma attacks.
• Chronic obstructive pulmonary disease (COPD) in adults aged 18 years and over.
• Relvar ellipta inhaler is used for people with severe COPD who have repeated attacks of breathlessness, despite regular use of long-acting bronchodilators such as formoterol or salmeterol.
• Only the Relvar ellipta 92/22 micrograms strength inhaler is used for COPD.

How does it work?

• Relvar ellipta inhaler contains two active ingredients, fluticasone and vilanterol.
• Fluticasone is a type of medicine known as a corticosteroid (or steroid). Corticosteroids are hormones produced naturally by the adrenal glands. They have many important functions, including control of inflammatory responses. Fluticasone is a synthetic corticosteroid and is used to decrease inflammation in the lungs. Corticosteroids are often simply called steroids, but it should be noted that they are very different from another group of steroids, called anabolic steroids, which have gained notoriety because of their abuse by some athletes and body builders.
• When fluticasone is inhaled into the lungs it is absorbed into the cells of the lungs and airways. Here it works by preventing the release of certain chemicals from the cells. These chemicals are important in the immune system and are normally involved in producing immune and allergic responses that result in inflammation. By decreasing the release of these chemicals in the lungs and airways, inflammation is reduced.
• In asthma, and in chronic obstructive airways disease (COPD) such as chronic bronchitis, the airways tighten due to inflammation and can also be blocked by mucus. This makes it difficult for air to get into and out of the lungs. Fluticasone is used in asthma to prevent the inflammation and excess mucus formation, and therefore help prevent asthma attacks and shortness of breath.
• Vilanterol is a type of medicine called a long-acting beta 2 agonist or bronchodilator. It works by acting on receptors in the lungs called beta 2 receptors. When vilanterol stimulates these receptors it causes the muscles in the airways to relax. This allows the airways to open.
• In asthma and COPD there is narrowing of the airways. By relaxing and opening the airways, vilanterol makes it easier to breathe.
• Inhaling the medicines allows them to act directly in the lungs where they are needed. 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 the medicines are taken by mouth.
• Relvar ellipta inhaler must be used regularly to reduce the inflammation in the lungs and prevent asthma attacks.

How do I use it?

• Make sure you read the information leaflet provided with your inhaler, as this will give detailed instructions on how to use and look after your inhaler.
• One dose should be inhaled from Relvar ellipta inhaler once a day, every day, even when you don't have symptoms. You can use the inhaler either in the morning or evening, but you should always use it at the same time each day.
• A dose counter on the inhaler indicates how many doses are left in the inhaler.
• Do not shake the inhaler before using it.
• To use the inhaler you first need to prepare a dose for inhalation. To do this simply open the cover of the inhaler and slide it down until you hear a click; this shows that there is one dose ready to be inhaled. If you do not hear a click or the counter does not count down one dose, this means that there is no dose ready for inhalation. You should ask your pharmacist for advice.
• If the cover is closed without inhaling the medicine, then the prepared single dose of medicine is lost.
• Before you inhale the prepared dose you should breath out as much as is comfortably possible first. You should not breathe out into the inhaler. Then put the inhaler mouthpiece between your lips and close your lips firmly around it, ensuring that the air vents are not blocked by your fingers. Take one long deep breath in and hold your breath for as long as possible (at least three to four seconds). Then remove the inhaler from your mouth and breathe out slowly and gently.
• The inhaler mouthpiece should be cleaned with a dry tissue if necessary and the cover replaced.
• If you forget to take a dose at your usual time don't worry, just take your next dose when it is due. Do not take a double dose to make up for a missed dose.
• Inhaling corticosteroids can sometimes cause a fungal infection in the mouth called oral thrush. To minimise the risk of this, you should rinse your mouth with water after each time you use this inhaler. Consult your doctor if you develop white patches in your mouth or throat, as these are symptoms of thrush and it may need to be treated.
• 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.

Warning!

• This medicine is known as a preventer and it should be taken regularly to prevent asthma attacks or wheezing. It should not be used to relieve an asthma attack or breathing difficulties, as it won't work quickly enough. An asthma attack needs to be treated with a medicine that quickly opens the airways, such as salbutamol or terbutaline. These are known as relievers, and you should make sure you carry your reliever inhaler 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 need to use your reliever more frequently than normal, or if it becomes less effective at treating attacks, you should consult your doctor. Your asthma or COPD may be getting worse and your doctor may need to prescribe you another medicine.
• Do not exceed the dose of this medicine that your doctor has prescribed for you.
• Inhalers may cause an unexpected increase in wheezing and difficulty breathing (paradoxical bronchospasm) straight after using them. If this happens, don't use the inhaler again, use your reliever inhaler to open your airways and consult your doctor.
• Inhaled corticosteroids have considerably fewer side effects than steroids taken by mouth. However, when taken for long periods of time at high doses, inhaled steroids do have the potential to cause side effects such as glaucoma, cataracts, thinning of the bones (osteoporosis), slowed growth in children and adolescents, Cushings syndrome, changes in mood or behaviour, and to suppress the functioning of the adrenal glands (glands that produce natural steroid hormones). For this reason your doctor will prescribe the lowest effective dose to control your symptoms, and monitor for these side effects. It is recommended that children receiving long-term treatment with corticosteroids have their growth monitored. If a child's growth appears to be slowed your doctor may refer them to a specialist respiratory paediatrician. For further information talk to your doctor or pharmacist.
• If you need to take high doses of Relvar ellipta for a long time, your body may become temporarily reliant on the medicine. This is because long-term use of corticosteroids can cause the adrenal glands to stop producing natural steroids. For this reason treatment must not be suddenly stopped. If your doctor wants you to stop treatment your dose should be tapered down gradually, to allow the adrenal glands to start producing adequate amounts of natural steroids again. People taking high doses of Relvar ellipta for a long time may also need to take extra steroid medicines during times of physical stress, for example illnesses, serious accidents or surgery. This is because your adrenal glands would normally produce more steroid hormones to cope with these situations, however, if the action of your adrenal glands is suppressed, this increase in hormones won't happen naturally. For more information talk to your doctor or pharmacist.
• People with severe asthma 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 asthma medicines can lower blood potassium levels.

Not to be used in

• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Relvar ellipta inhaler contains lactose).
• The safety and effectiveness of this medicine in for treating asthma in children under 12 years of age has not been fully established. It is not currently recommended for this age group.
• 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.

Use with caution in

• People with a history of tuberculosis infection in the lungs.
• People with heart disease.
• People with an irregular heartbeat (arrhythmia).
• High blood pressure (hypertension).
• Overactive thyroid gland (hyperthyroidism).
• People with moderate to severely decreased liver function.
• Diabetes.
• People with low levels of potassium in their blood (hypokalaemia).
• People with COPD who smoke or have a history of pneumonia.

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 inhaler for use during pregnancy has not been established by the manufacturer. As it contains new medicines, they do not recommend it for use in pregnancy, unless there is no alternative that is established as safer. However, it is important that asthma is well controlled in pregnant women. Wherever possible, asthma medications should be taken by inhaler, as this minimises the amount of medicine that enters the bloodstream and crosses the placenta. It is important to get medical advice from your doctor on how to control your asthma during pregnancy.
• In general, asthma inhalers can be used as normal during breastfeeding, because the amount of medicine that passes into the breast milk after using an inhaler is negligible and unlikely to harm the baby. However, it is not known to what extent the medicines in this inhaler pass into breast milk. Since it contains new medicines you should seek medical advice from your doctor before breastfeeding while using it.

Label warnings

• Do not stop taking this medication except on your doctor's advice.
• Follow the printed instructions you have been given with this medication.

Side effects

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, it does not mean that all people using this medicine will experience that or any side effect.

Very common 

• Headache.
• Inflammation of the nose and throat, causing a blocked or runny nose and sore throat (nasopharyngitis).

Common 

• Thrush infection of the mouth and throat (oral thrush). This can usually be avoided by rinsing the mouth out with water and spitting it out immediately after each time you use your inhaler. If you do get oral thrush your doctor can prescribe an antifungal medicine to treat it.
• Infection of the upper respiratory tract.
• Cough.
• Hoarse voice.
• Sore mouth and throat irritation.
• Inflammation and soreness of the throat (pharyngitis).
• Inflammation of the sinuses (sinusitis).
• Inflammation of the lining of the nose (rhinitis) causing a blocked or runny nose.
• Pneumonia in people with COPD.
• Bronchitis.
• Bone fractures in people with COPD.
• Pain in the joints (arthralgia).
• Fever.
• Back pain.
• Abdominal pain.

Uncommon 

• Irregular heartbeat.

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.

How can this medicine 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.

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

Medicines in the same class as vilanterol can potentially cause a serious decrease in the level of potassium in the blood (hypokalaemia), which may result in adverse effects. It is not yet known if vilanterol can have this effect as well. However, if it does this could be increased by the following medicines, which can also lower potassium in the blood:

• acetazolamide
• 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 asthma, who may be taking several of these medicines, should have their blood potassium levels monitored regularly.

The following medicines may increase the amount of vilanterol or fluticasone that is found in the bloodstream after inhaling this medicine:

• the azole antifungals ketoconazole, itraconazole or voriconazole
• macrolide antibiotics such as clarithromycin or telithromycin
• protease inhibitors for HIV infection such as ritonavir
• telaprevir.

These medicines can therefore increase your exposure to vilanterol and fluticasone and so increase the risk of side effects on the rest of the body.

References:

http://www.mims.co.uk/relvar-ellipta-combination-inhaler-asthma-copd/respiratory-system/article/1228322

http://www.netdoctor.co.uk/medicines/lungs/a8896/relvar-ellipta-fluticasone-vilanterol/

http://www.medicines.ie/medicine/15906/SPC/Relvar+Ellipta+184+micrograms+22+micrograms+inhalation+powder,+pre-dispensed/#MACHINEOPS

http://www.pharmaceutical-journal.com/news-and-analysis/relvar-ellipta-launched-for-asthma-and-copd-patients/11132593.article

https://hcp.gsk.ie/products/relvar.html

https://public.gsk.ie/products/relvar.html