Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Anoro Ellipta 55 micrograms/22 micrograms inhalation powder, pre-dispensed
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Vilanterol trifenatate, Umeclidinium bromide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What ANORO ELLIPTA is ANORO ELLIPTA contains two active substances umeclidinium bromide and vilanterol. These belong to a group of medicines called bronchodilators. What ANORO ELLIPTA is used for ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term condition characterised by breathing difficulties that slowly get worse. In COPD the muscles around the airways tighten. This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs. When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life. ANORO ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol). If you do not have a quick-acting inhaler contact your doctor.
2.
What you need to know before you take it
e ANORO ELLIPTA
Do not use ANORO ELLIPTA:
1
–
if you are allergic to umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
If you think this applies to you, do not use this medicine until you have checked with your doctor. Warnings and precautions Talk to your doctor before using this medicine: if you have asthma (Do not use ANORO ELLIPTA to treat asthma) if you have heart problems or high blood pressure if you have an eye problem called narrow-angle glaucoma if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder if you suffer from epilepsy if you have thyroid gland problems if you have low potassium in your blood if you have diabetes if you have severe liver problems Check with your doctor if you think any of these may apply to you. Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your ANORO ELLIPTA inhaler: stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm. Eye problems during treatment with ANORO ELLIPTA If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with ANORO ELLIPTA: stop using this medicine and seek medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma. Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years. Other medicines and ANORO ELLIPTA Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are not sure what your medicine contains talk to your doctor or pharmacist. Some medicines may affect how this medicine works, or make it more likely that you'll have side effects. These include: medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems ketoconazole or itraconazole, to treat fungal infections clarithromycin or telithromycin, to treat bacterial infections ritonavir, to treat HIV infection medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthine or steroids) other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. tiotropium, indacaterol. Do not use ANORO ELLIPTA if you already use these medicines.
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Tell your doctor or pharmacist if you are taking any of these. Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of ANORO ELLIPTA. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Do not use this medicine if you are pregnant unless your doctor tells you that you can. It is not known whether the ingredients of ANORO ELLIPTA can pass into breast milk. If you are breastfeeding, you must check with your doctor before you use ANORO ELLIPTA. Do not use this medicine if you are breast-feeding unless your doctor tells you that you can. Driving and using machines It is unlikely that ANORO ELLIPTA will affect your ability to drive or use machines. ANORO ELLIPTA contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
3.
How to use ANORO ELLIPTA
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one inhalation every day at the same time of day. You only need to inhale once a day because the effect of this medicine lasts for 24 hours. Do not use more than your doctor tells you to use. Use ANORO ELLIPTA regularly It is very important that you use ANORO ELLIPTA every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night. ANORO ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).
How to take it
the inhaler See 'Step-by-step instructions' at the end of this leaflet for full information. ANORO ELLIPTA is for inhalation use. To use ANORO ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler. If your symptoms do not improve If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often: contact your doctor as soon as possible. If you use more ANORO ELLIPTA than you should If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention. If possible, show them the inhaler, the package or this leaflet. You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache. 3
If you forget to use ANORO ELLIPTA Do not inhale an extra dose to make up for a forgotten dose. Just inhale your next dose at the usual time. If you become wheezy or breathless, use your quick-acting reliever inhaler (such as salbutamol), then seek medical advice. If you stop using ANORO ELLIPTA Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. Do not stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions If you have any of the following symptoms after taking ANORO ELLIPTA stop using this medicine and tell your doctor immediately. Uncommon side effects (may affect up to 1 in 100 people):
- skin rash (hives) or redness Rare side effects (may affect up to 1 in 1 000 people):
- swelling, sometimes of the face or mouth (angioedema)
- becoming very wheezy, coughing or having difficulty in breathing
- suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness) Immediate breathing difficulties Immediate breathing difficulties after using ANORO ELLIPTA are rare. If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine: stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm. Other side effects Common (may affect up to 1 in 10 people)
- painful and frequent urination (may be signs of a urinary tract infection)
- combination of sore throat and runny nose
- sore throat
- feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis)
- headache
- cough
- pain and irritation in the back of the mouth and throat
- constipation
- dry mouth
- infection of the upper airways. Uncommon 4
(may affect up to 1 in 100 people)
- irregular heart beat
- faster heart beat
- awareness of heart beat (palpitations)
- muscle spasms
- tremor
- taste disturbance
- hoarseness. Rare (may affect up to 1 in 1 000 people)
- blurred vision
- increase of the measured eye pressure
- decrease in vision or pain in your eyes (possible signs of glaucoma).
- difficulty and pain when passing urine – these may be signs of a bladder obstruction or urinary retention. Not known (frequency cannot be estimated from the available data)
- dizziness. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5.
How to store it
ANORO ELLIPTA
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after 'EXP'. The expiry date refers to the last day of that month. Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use. Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray. Write the date the inhaler should be thrown away on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray. Do not store above 30°C. If stored in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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6.
Contents of the pack and other information
What ANORO ELLIPTA contains The active substances are umeclidinium bromide and vilanterol. Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate). The other ingredients are lactose monohydrate (see section 2 under 'ANORO ELLIPTA contains lactose') and magnesium stearate. What ANORO ELLIPTA looks like and contents of the pack ANORO ELLIPTA is an inhalation powder, pre-dispensed. The Ellipta inhaler consists of a light grey plastic body, a red mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant packet, to reduce moisture in the packaging. The active substances are present as a white powder in separate blisters inside the inhaler. ANORO ELLIPTA is available in packs of 1 inhaler containing either 7 or 30 doses and in multipacks containing 90 (3 inhalers of 30) doses. Not all pack sizes may be marketed. Marketing Authorisation Holder: GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom Manufacturer: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street Ware Hertfordshire SG12 0DJ United Kingdom Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information: Product name
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder pre-dispensed
Reference numbers
19494/0268
This is a service provided by the Royal National Institute of Blind People. 6
This leaflet was last revised in 02/2025 Trade marks are owned by or licensed to the GSK group of companies. © 2025 GSK group of companies or its licensor.
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Step-by-step instructions What is the ELLIPTA inhaler? The first time you use ANORO ELLIPTA you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away. Your ANORO ELLIPTA inhaler carton contains
Tray lid
Carton Inhaler This leaflet Desiccant Tray
The inhaler is packaged in a tray. Do not open the tray until you are ready to start using your new inhaler. When you are ready to use your inhaler, peel back the lid to open the tray. The tray contains a desiccant sachet, to reduce moisture. Throw this desiccant sachet away – do not open, eat or inhale it.
Desiccant
When you take the inhaler out of its tray, it will be in the 'closed' position. Do not open the inhaler until you are ready to inhale a dose of medicine. When the tray is opened, write the "Discard by" date on the inhaler label in the space provided. The "Discard by" date is 6 weeks from the date you open the tray. After this date the inhaler should no longer be used. The tray can be discarded after first opening. 8
If stored in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use. The step-by-step instructions for use of the inhaler provided below can be used for either the 30-dose inhaler (30-day supply) or the 7-dose inhaler (7-day supply). 1)
Read this before you start
If you open and close the cover without inhaling the medicine, you will lose the dose. The lost dose will be securely held inside the inhaler, but it will no longer be available. It is not possible to accidentally take extra medicine or a double dose in one inhalation.
2)
Prepare a dose
Wait to open the cover until you are ready to inhale your dose. Do not shake the inhaler. •
Slide the cover down until you hear a "click".
Your medicine is now ready to be inhaled. The dose counter counts down by 1 to confirm.
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•
3)
If the dose counter does not count down as you hear the "click", the inhaler will not deliver medicine. Take it back to your pharmacist for advice. Inhale your medicine
•
While holding the inhaler away from your mouth, breathe out as far as is comfortable. Do not breathe out into the inhaler.
•
Put the mouthpiece between your lips, and close your lips firmly around it. Do not block the air vent with your fingers.
•
Take one long, steady, deep breath in. Hold this breath in for as long as possible (at least 3-4 seconds).
•
Remove the inhaler from your mouth.
•
Breathe out slowly and gently.
You may not be able to taste or feel the medicine, even when you are using the inhaler correctly. If you want to clean the mouthpiece, use a dry tissue, before you close the cover. 4)
Close the inhaler
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Slide the cover upwards as far as it will go, to cover the mouthpiece.
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Frequently asked questions about Anoro Ellipta 55 micrograms/22 micrograms inhalation powder, pre-dispensed
How do I take Anoro Ellipta 55 micrograms/22 micrograms inhalation powder, pre-dispensed?
Anoro Ellipta 55 micrograms/22 micrograms inhalation powder, pre-dispensed comes as inhaler containing 55mcg / 22mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Anoro Ellipta 55 micrograms/22 micrograms inhalation powder, pre-dispensed?
The active substance in Anoro Ellipta 55 micrograms/22 micrograms inhalation powder, pre-dispensed is vilanterol trifenatate, umeclidinium bromide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Anoro Ellipta 55 micrograms/22 micrograms inhalation powder, pre-dispensed, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Anoro Ellipta 55 micrograms/22 micrograms inhalation powder, pre-dispensed without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: vilanterol trifenatate, umeclidinium bromide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
ANORO ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
4.2. Posology and method of administration
Posology
The recommended and maximum dose is one inhalation once daily.
ANORO ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation. If a dose is missed the next dose should be inhaled at the usual time the next day.
Special populations
Elderly
No dose adjustment is required in patients 65 years of age or older (see section 5.2).
Renal impairment
No dose adjustment is required in patients with renal impairment (see section 5.2).
Hepatic impairment
No dose adjustment is required in patients with mild or moderate hepatic impairment. The use of ANORO ELLIPTA has not been studied in patients with severe hepatic impairment and should be used with caution (see section 5.2).
Paediatric population
There is no relevant use of ANORO ELLIPTA in the paediatric population (under 18 years of age) for the indication of COPD.
Method of administration
For inhalation use only.
The following instructions for the 30 dose inhaler (30 day supply) also apply to the 7 dose inhaler (7 day supply).
The ELLIPTA inhaler contains pre-dispensed doses and is ready to use.
The inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture. The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled. The patient should be advised to not open the tray until they are ready to inhale a dose.
The inhaler will be in the 'closed' position when it is first taken out of its sealed tray. The “Discard by” date should be written on the inhaler label in the space provided. The “Discard by” date is 6 weeks from the date of opening the tray. After this date the inhaler should no longer be used. The tray can be discarded after first opening.
If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost. The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.
It is not possible to accidentally take extra medicinal product or a double dose in one inhalation.
Instructions for use:
a) Prepare a dose
Open the cover when ready to inhale a dose. The inhaler should not be shaken.
Slide the cover down until a “click” is heard. The medicinal product is now ready to be inhaled.
The dose counter counts down by 1 to confirm. If the dose counter does not count down as the “click” is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice.
b) How to inhale the medicinal product
The inhaler should be held away from the mouth breathing out as far as is comfortable. But not breathing out into the inhaler.
The mouthpiece should be placed between the lips and the lips should then be closed firmly around it. The air vents should not be blocked with fingers during use.
• Inhale with one long, steady, deep breath in. This breath should be held in for as long as possible (at least 3-4 seconds).
• Remove the inhaler from the mouth.
• Breathe out slowly and gently.
The medicinal product may not be tasted or felt, even when using the inhaler correctly.
The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover.
c) Close the inhaler
Slide the cover upwards as far as it will go, to cover the mouthpiece.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Asthma
This medicinal product should not be used in patients with asthma since it has not been studied in this patient population.
Paradoxical bronchospasm
Administration of umeclidinium/vilanterol may produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, treatment should be discontinued immediately and alternative therapy instituted if necessary.
Not for acute use
Umeclidinium/vilanterol is not indicated for the treatment of acute episodes of bronchospasm.
Deterioration of disease
Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control. In the event of deterioration of COPD during treatment with umeclidinium/vilanterol, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Cardiovascular effects
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium/vilanterol (see section 4.8). Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies. Therefore, umeclidinium/vilanterol should be used with caution in patients with severe cardiovascular disease.
Antimuscarinic activity
Due to its antimuscarinic activity, umeclidinium/vilanterol should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Hypokalaemia
Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.
No clinically relevant effects of hypokalaemia were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose. Caution should be exercised when umeclidinium/vilanterol is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).
Hyperglycaemia
Beta2-adrenergic agonists may produce transient hyperglycemia in some patients.
No clinically relevant effects on plasma glucose were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose. Upon initiation of treatment with umeclidinium/vilanterol plasma glucose should be monitored more closely in diabetic patients.
Coexisting conditions
Umeclidinium/vilanterol should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Excipients
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.
4.5. Interaction with other medicinal products and other forms of interaction
Clinically significant interactions mediated by umeclidinium/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Beta-adrenergic blockers
Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol. Concurrent use of either non-selective or selective beta-adrenergic blockers should be avoided unless there are compelling reasons for their use.
Metabolic and transporter based interactions
Vilanterol is a substrate of cytochrome P450 3A4 (CYP3A4). Concomitant administration of strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin) may inhibit the metabolism of, and increase the systemic exposure to, vilanterol. Co-administration with ketoconazole (400 mg) in healthy volunteers increased mean vilanterol AUC(0-t) and Cmax, 65% and 22% respectively. The increase in vilanterol exposure was not associated with an increase in beta-adrenergic agonist related systemic effects on heart rate, blood potassium or QT interval (corrected using the Fridericia method). Care is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol, which could lead to an increase in the potential for adverse reactions. Verapamil, a moderate CYP3A4 inhibitor, did not significantly affect the pharmacokinetics of vilanterol.
Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6). The steady-state pharmacokinetics of umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers). No effect on umeclidinium AUC or Cmax was observed at a 8-fold higher dose. An approximately 1.3-fold increase in umeclidinium AUC was observed at 16-fold higher dose with no effect on umeclidinium Cmax. Based on the magnitude of these changes, no clinically relevant interaction is expected when umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients genetically deficient in CYP2D6 activity (poor metabolisers).
Both umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp). The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium and vilanterol was assessed in healthy volunteers. No effect of verapamil was observed on umeclidinium or vilanterol Cmax. An approximately 1.4-fold increase in umeclidinium AUC was observed with no effect on vilanterol AUC. Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with P-gp inhibitors.
Other antimuscarinics and sympathomimetics
Co-administration of umeclidinium/vilanterol with other long-acting muscarinic antagonists, long-acting beta2-adrenergic agonists or medicinal products containing either of these agents has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist adverse reactions (see sections 4.4 and 4.9).
Hypokalaemia
Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution (see section 4.4).
Other medicinal products for COPD
Although no formal in vivo drug interaction studies have been performed, inhaled umeclidinium/vilanterol has been used concomitantly with other COPD medicinal products including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of umeclidinium/vilanterol in pregnant women. Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant after administration of vilanterol (see section 5.3).
Umeclidinium/vilanterol should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Breast-feeding
It is unknown whether umeclidinium or vilanterol are excreted in human milk. However, other beta2-adrenergic agonists are detected in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue umeclidinium/vilanterol therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data on the effects of umeclidinium/vilanterol on human fertility. Animal studies indicate no effects of umeclidinium or vilanterol on fertility.
4.7. Effects on ability to drive and use machines
Umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most frequently reported adverse reaction is nasopharyngitis (9%).
Tabulated list of adverse reactions
The safety profile of ANORO ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6 855 patients with COPD and from spontaneous reporting. The clinical development programme included 2 354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1 296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 12-month study.
The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed in the integration of five 24-week studies and in the 12-month safety study.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from available data).
System Organ Class
Adverse reactions
Frequency
Infections and infestations
Urinary tract infection
Sinusitis
Nasopharyngitis
Pharyngitis
Upper respiratory tract infection
Common
Common
Common
Common
Common
Immune system disorders
Hypersensitivity reactions including:
Rash
Anaphylaxis, angioedema, and urticaria
Uncommon
Rare
Nervous system disorders
Headache
Tremor
Dysgeusia
Dizziness
Common
Uncommon
Uncommon
Not known
Eye disorders
Vision blurred
Glaucoma
Intraocular pressure increased
Eye pain
Rare
RareRare
Rare
Cardiac disorders
Atrial fibrillation
Supraventricular tachycardia
Rhythm idioventricular
Tachycardia
Supraventricular extrasystoles
Palpitations
Uncommon
Uncommon
Uncommon
Uncommon
Uncommon
Uncommon
Respiratory, thoracic and mediastinal disorders
Cough
Oropharyngeal pain
Dysphonia
Paradoxical bronchospasm
Common
Common
Uncommon
Rare
Gastrointestinal disorders
Constipation
Dry mouth
Common
Common
Musculoskeletal and connective tissue disorders
Muscle spasms
Uncommon
Renal and urinary disorders
Urinary retention
DysuriaBladder outlet obstruction
Rare
RareRare
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
An overdose of umeclidinium/vilanterol will likely produce signs and symptoms due to the individual components' actions, consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry mouth, visual accommodation disturbances and tachycardia) or those with overdose of other beta2-adrenergic agonists (e.g. arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Vilanterol trifenatate, Umeclidinium bromide. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Incruse Ellipta partial — not the same combinationUmeclidinii bromidum · inhaler / nebuliser
- Rolufta Ellipta partial — not the same combinationUmeclidinium · inhaler / nebuliser
- Anoro Ellipta partial — not the same combinationUmeclidinium + Vilanterolum · inhaler / nebuliser
- Laventair Ellipta partial — not the same combinationUmeclidinium + Vilanterolum · inhaler / nebuliser
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Anoro Ellipta 55 micrograms/22 micrograms inhalation powder, pre-dispensed. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.