Rolufta Ellipta (Previously Rolufta)

Posology The recommended dose is one inhalation once daily. It should be administered each day at the same time of the day to maintain bronchodilation. The maximum dose is one inhalation once daily. If a dose is missed the next dose should be inhaled at the usual time the next day.

2). 2). 3 Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. 2). Paediatric population There is no relevant use of umeclidinium 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 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. 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. 4 c) Close the inhaler Slide the cover upwards as far as it will go, to cover the mouthpiece.

Summary of the safety profile The most frequently reported adverse reactions are nasopharyngitis (6%) and upper respiratory tract infection (5%). Tabulated list of adverse reactions The safety profile of umeclidinium was evaluated in patients with COPD who received doses of 55 micrograms or greater for up to one year.

This includes patients who received the recommended dose of 55 micrograms once daily. The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed from efficacy studies, the long-term safety study (which involved patients who received umeclidinium), post-marketing studies and spontaneous reporting.

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 Nasopharyngitis Upper respiratory tract infection Urinary tract infection Sinusitis Pharyngitis Common Common Common Common Uncommon Immune system disorders Hypersensitivity reactions including: Rash, urticaria and pruritus Anaphylaxis Uncommon Rare Nervous system disorders Headache Dysgeusia Dizziness Common Uncommon Not known Eye disorders Eye pain Glaucoma Vision blurred Intraocular pressure increased Rare Not known Not known Not known Cardiac disorders Tachycardia Atrial fibrillation Rhythm idioventricular Supraventricular tachycardia Supraventricular extrasystoles Common Uncommon Uncommon Uncommon Uncommon Respiratory, thoracic and mediastinal disorders Cough Oropharyngeal pain Dysphonia Common Common Uncommon Gastrointestinal disorders Constipation Dry mouth Common Uncommon Renal and urinary disorders Urinary retention Dysuria Not known Not known 7 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Asthma Umeclidinium should not be used in patients with asthma since it has not been studied in this patient population. Paradoxical bronchospasm Administration of umeclidinium may produce paradoxical bronchospasm that may be life-threatening.

If paradoxical bronchospasm occurs, treatment should be discontinued immediately and alternative therapy instituted if necessary. Deterioration of disease Umeclidinium is intended for the maintenance treatment of COPD. e. as rescue therapy for the treatment of acute episodes of bronchospasm.

Acute symptoms should be treated with an inhaled short-acting bronchodilator. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control. In the event of deterioration of COPD during treatment with umeclidinium, 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 should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.

Antimuscarinic activity Due to its antimuscarinic activity, umeclidinium should be used with caution in patients with urinary retention or with narrow-angle glaucoma. 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.

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