Duaklir Genuair

Posology The recommended dose is one inhalation twice daily. If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose.

2). 2). 2). 3 Paediatric population There is no relevant use of Duaklir Genuair in children and adolescents (under 18 years of age) for the indication of COPD. Method of administration For inhalation use. Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers the patients may have used previously.

It is important to instruct the patients to read the Instructions for Use in the Package Leaflet. Before first use, the sealed bag should be teared open, and the inhaler removed. The bag and the desiccant should be thrown away. 6.

The presentation of the safety profile is based on the experience with Duaklir Genuair and the individual components. Summary of the safety profile The safety experience with Duaklir Genuair comprised exposure in clinical trials at the recommended therapeutic dose for up to 12 months, and in post-marketing experience.

Adverse reactions associated with Duaklir Genuair were similar to those of the individual components. As Duaklir Genuair contains aclidinium and formoterol, the type and severity of adverse reactions associated with each of the components may be expected with Duaklir Genuair.

8%). Tabulated summary of adverse reactions The Duaklir Genuair clinical development programme was conducted in patients with moderate or severe COPD. A total of 1222 patients were treated with Duaklir Genuair 340 micrograms /12 micrograms.

The frequencies assigned to the adverse reactions are based on crude incidence rates observed with Duaklir Genuair 340 micrograms /12 micrograms in the pooled analysis of randomised, placebo-controlled Phase III clinical studies of at least six months duration, or on experience with individual components or on post-marketing study results.

The frequency of adverse reactions is defined using the following convention: very common (≥1/10); 6 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 Preferred term Frequency Infectious and infestations Nasopharyngitis Urinary tract infection Sinusitis Tooth abscess Common Immune system disorders Hypersensitivity Rare Angioedema Anaphylactic reaction Not known Metabolism and nutrition disorders Hypokalaemia Uncommon Hyperglycaemia Uncommon Psychiatric disorders Insomnia Anxiety Common Agitation Uncommon Nervous system disorders Headache Dizziness Tremor Common Dysgeusia Uncommon Eye disorders Blurred vision Uncommon Cardiac disorders Cardiac arrhythmias, including atrial fibrillation and paroxysmal tachycardia Tachycardia Electrocardiogram QTc prolonged Palpitations Angina pectoris Uncommon Respiratory, Thoracic and mediastinal disorders Cough Common Dysphonia Throat irritation Uncommon Bronchospasm, including paradoxical Rare Gastrointestinal disorders Diarrhoea Nausea Dry mouth Common Stomatitis Uncommon Skin and subcutaneous tissue disorders Rash Pruritus Uncommon Musculoskeletal and connective tissue disorders Myalgia Muscle spasms Common Renal and urinary disorders Urinary retention Uncommon Investigations Blood creatine phosphokinase increased Common Blood pressure increased Uncommon 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 7 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Asthma Duaklir Genuair should not be used in asthma; clinical studies of Duaklir Genuair in asthma have not been conducted. Paradoxical bronchospasm In clinical studies, paradoxical bronchospasm was not observed with Duaklir Genuair at its recommended dose.

However, paradoxical bronchospasm has been observed with other inhalation therapies. If this occurs, medicinal product should be stopped and other treatment will be considered. Not for acute use Duaklir Genuair is not indicated for the treatment of acute episodes of bronchospasm.

Cardiovascular effects β2-adrenergic agonists may produce increases in pulse rate and blood pressure, electrocardiogram (ECG) changes such as T wave flattening, ST segment depression and prolongation of the QTc- interval in some patients.

In case such effects occur, treatment may need to be discontinued. 5). 8). Therefore, Duaklir Genuair should be used with caution in patients with cardiac arrhythmias, a history of cardiac arrhythmias or with risk factors for cardiac arrhythmias.

Systemic effects Duaklir Genuair should be used with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis and phaeochromocytoma. 4 Metabolic effects of hyperglycaemia and hypokalaemia may be observed with high doses of β2-adrenergic agonists.

1%) and similar to placebo. Hypokalaemia is usually transient, not requiring supplementation. 5). Hypokalaemia increases susceptibility to cardiac arrhythmias. Due to its anticholinergic activity, Duaklir Genuair should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely).

Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries. Lactose content Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicinal product.

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