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Xoterna Breezhaler is a brand name for Indacaterol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose is the inhalation of the content of one capsule once daily using the Xoterna Breezhaler inhaler. Xoterna Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day.
Patients should be instructed not to take more than one dose in a day. Special populations Elderly population Xoterna Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older). 3 Renal impairment Xoterna Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
2). Hepatic impairment Xoterna Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment. 2). Paediatric population There is no relevant use of Xoterna Breezhaler in the paediatric population (under 18 years) in the indication COPD.
The safety and efficacy of Xoterna Breezhaler in children have not been established. No data are available. Method of administration For inhalation use only. The capsules must not be swallowed. 6). The inhaler provided with each new prescription should be used.
Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it. 6.
The presentation of the safety profile is based on the experience with Xoterna Breezhaler and the individual active substances. Summary of the safety profile The safety experience with Xoterna Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Xoterna Breezhaler showed similar adverse reactions to the individual components. As it contains indacaterol and glycopyrronium, the type and severity of adverse reactions associated with each of these components may be expected in the combination.
The safety profile is characterised by typical anticholinergic and beta-adrenergic symptoms related to the individual components of the combination. Other most common adverse reactions related to the medicinal product (at least 3% of patients for Xoterna Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Tabulated summary of adverse reactions Adverse reactions detected during clinical trials and from post-marketing sources are listed by MedDRA system organ class (Table 1). Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Table 1 Adverse reactions Adverse reactions Frequency category Infections and infestations Upper respiratory tract infection Very common Nasopharyngitis Common Urinary tract infection Common Sinusitis Common Rhinitis Common Immune system disorders Hypersensitivity Common Angioedema2 Uncommon Metabolism and nutrition disorders Hyperglycaemia and diabetes mellitus Common Psychiatric disorders Insomnia Uncommon Nervous system disorders Dizziness Common Headache Common Paraesthesia Rare Eye disorders Glaucoma1 Uncommon 8 Cardiac disorders Ischaemic heart disease Uncommon Atrial fibrillation Uncommon Tachycardia Uncommon Palpitations Uncommon Respiratory, thoracic and mediastinal disorders Cough Common Oropharyngeal pain including throat irritation Common Paradoxical bronchospasm Uncommon Dysphonia2 Uncommon Epistaxis Uncommon Gastrointestinal disorders Dyspepsia Common Dental caries Common Gastroenteritis Uncommon Dry mouth Uncommon Skin and subcutaneous tissue disorders Pruritus/rash Uncommon Musculoskeletal and connective tissue disorders Musculoskeletal pain Uncommon Muscle spasm Uncommon Myalgia Uncommon Pain in extremity Uncommon Renal and urinary disorders Bladder obstruction and urinary retention Common General disorders and administration site conditions Pyrexia1 Common Chest pain Common Oedema peripheral Uncommon Fatigue Uncommon 1 Adverse reaction observed with Xoterna Breezhaler, but not with the individual components.
5). Asthma Xoterna Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication. Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.
Not for acute use Xoterna Breezhaler is not indicated for the treatment of acute episodes of bronchospasm. Hypersensitivity Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Xoterna Breezhaler.
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.
4 Paradoxical bronchospasm Administration of Xoterna Breezhaler may result in paradoxical bronchospasm which can be life-threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted. Anticholinergic effects related to glycopyrronium Narrow-angle glaucoma No data are available in patients with narrow-angle glaucoma, therefore Xoterna Breezhaler should be used with caution in these patients.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Xoterna Breezhaler should any of these signs or symptoms develop. Urinary retention No data are available in patients with urinary retention, therefore Xoterna Breezhaler should be used with caution in these patients.
2-fold in subjects with severe renal impairment and end-stage renal disease. 2). These patients should be monitored closely for potential adverse reactions. Cardiovascular effects Xoterna Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Reports received from post-marketing experience; frequencies calculated, however, on the basis of clinical trial data. Description of selected adverse reactions Cough was common, but usually of mild intensity. 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 the national reporting system listed in Appendix V.
Beta2-adrenergic agonists may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In case such effects occur with this medicinal product, treatment may need to be discontinued.
In addition, beta-adrenergic agonists have been reported to produce electrocardiographic (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
Therefore, long-acting beta2-adrenergic agonists (LABA) or LABA-containing combination products such as Xoterna Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval.
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 (>450 ms) were excluded from the clinical trials, and therefore there is no experience in these patient groups.
Xoterna Breezhaler should be used with caution in these patient groups. 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. 5). 1). Hyperglycaemia Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose. Upon initiation of treatment with Xoterna Breezhaler plasma glucose should be monitored more closely in diabetic patients.
7%). Xoterna Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled, therefore caution and appropriate monitoring are advised in such patients. General disorders Xoterna Breezhaler 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 take this medicinal product.