Anoro Ellipta (Previously Anoro)

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.

2). 2). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. 2). 3 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.

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 7 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 Rare Rare 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 Dysuria Bladder outlet obstruction Rare Rare Rare Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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.

g. 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. 5). Hyperglycaemia Beta2-adrenergic agonists may produce transient hyperglycemia in some patients.

5 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.

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