Prescribing Information

Ultibro® Breezhaler® (indacaterol maleate/ glycopyrronium bromide inhalation powder)

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ABBREVIATED PRESCRIBING INFORMATION

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

Ultibro Breezhaler (glycopyrronium bromide, indacaterol maleate)

Presentation: Ultibro Breezhaler 85mcg / 43mcg inhalation powder hard capsules containing indacaterol maleate and glycopyrronium bromide respectively and separate Ultibro Breezhaler inhaler.

Indications: A maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 

Dosage and Administration: Recommended dose is the inhalation of the content of one capsule once daily, administered at the same time of the day each day, using the Ultibro Breezhaler inhaler. Capsules must not be swallowed. No dose adjustment required in elderly patients, for patients with mild and moderate hepatic impairment or for patients with mild to moderate renal impairment.  No data available for use in patients with severe hepatic impairment and should only be used in patients with severe renal impairment or end-stage renal disease requiring dialysis if the expected benefit outweighs the potential risk.  No relevant use in the paediatric population.  

Contraindications:  Hypersensitivity to the active substances or to any of the excipients.

Warnings/Precautions:  Not to be administered concomitantly with medicinal products containing other LABA’s or LAMA’s.  Asthma: ♦ULTIBRO BREEZHALER SHOULD NOT BE USED FOR TREATMENT OF ASTHMA.  Acute use: ♦Not indicated for treatment of acute episodes of bronchospasm. Hypersensitivity: ♦Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium. If signs suggesting allergic reactions occur (in particular, angioedema, difficulties in breathing or swallowing, swelling of the tongue, lips and face, urticaria or skin rash), treatment should be discontinued immediately and alternative therapy instituted. Paradoxical bronchospasm: ♦If paradoxical bronchospasm occurs, Ultibro Breezhaler should be discontinued immediately and alternative therapy instituted.  Anticholinergic effects related to glycopyrronium: ♦To be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Patients with severe renal impairment: ♦Should only be used in patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, if the expected benefit outweighs the potential risk.  These patients should be monitored closely for potential adverse reactions.  Cardiovascular effects: ♦To be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with known or suspected prolongation of the QT interval or patients treated with medicinal products affecting the QT interval and in patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged.  ♦LABA’s may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms, ECG changes. In case such effects occur, treatment may need to be discontinued.  Hypokalaemia: ♦ LABA’s may produce significant hypokalaemia in some patients, which has the potential to produce cardiovascular effects.  In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment which may increase the susceptibility to cardiac arrhythmias.  Hyperglycaemia: ♦Inhalation of high doses of LABA’s may produce increases in plasma glucose. Upon initiation of treatment with Ultibro Breezhaler plasma glucose should be monitored more closely in diabetic patients therefore caution and appropriate monitoring are advised in such patients.  ♦ Ultibro Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled. General disorders: ♦To be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to LABA’s.  Excipients: ♦ This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption should not take this medicine.

Interactions: ♦Concomitant use is not recommended with beta adrenergic blockers, anticholinergics or sympathomimetics.  ♦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. ♦Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-gp, does not raise any safety concerns given the safety experience of treatment with indacaterol.  ♦No clinically relevant drug interaction is expected when glycopyrronium is co administered with cimetidine or other inhibitors of the organic cation transport. 

Pregnancy and Lactation: ♦Ultibro Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.  ♦Not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk.  Use of Ultibro Breezhaler by breast feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.

Undesirable effects:  ♦Very common: upper respiratory tract infection.  ♦Common: nasopharyngitis, urinary tract infection, sinusitis, rhinitis, hypersensitivity, hyperglycaemia and diabetes mellitus, dizziness, headache, cough, oropharyngeal pain including throat irritation, dyspepsia, dental caries, bladder obstruction and urinary retention, pyrexia, chest pain.  ♦Uncommon: angioedema,  insomnia, glaucoma, ischaemic heart disease, atrial fibrillation, tachycardia, palpitations, paradoxical bronchospasm, dysphonia, epistaxis, gastroenteritis, dry mouth, pruritus / rash, musculoskeletal pain, muscle spasm, myalgia, pain in extremity,  oedema peripheral and fatigue.  ♦Please refer to SmPC for a full list of adverse events for Ultibro Breezhaler. 

Pack sizes: Cartons containing 10 capsules (1x10 capsule blister strips) and one Ultibro Breezhaler inhaler or 30 capsules (3x10 capsule blister strips) and one Ultibro Breezhaler inhaler.

Legal Category:    POM

Marketing Authorisation Holder: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing Authorisation Numbers: EU/1/13/862/007 & 003.

Full prescribing information is available on request from Novartis Ireland Ltd, Vista Building, Elm Park Business Park, Dublin 4. Tel: 01 2601255 or at www.medicines.ie. Detailed information on this product is also available on the website of the European Medicines Agency http://www.ema.europa.eu

Prescribing Information last revised: May 2019

 

Reporting suspected adverse reactions of the medicinal product is important to Novartis and the HPRA. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported via HPRA Pharmacovigilance, website www.hpra.ie. Adverse events could also be reported to Novartis preferably via www.report.novartis.com or by email: [email protected] or by calling 01 2080 612.

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