STRIVERDI RESPIMAT

Posology The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler. Two actuations (puffs) from the Respimat inhaler comprise one medicinal dose. Adults The recommended dose is 5 microgram olodaterol given as two actuations (puffs) from the Respimat inhaler once daily, at the same time of the day.

The recommended dose should not be exceeded. Elderly population Elderly patients can use Striverdi Respimat at the recommended dose. Hepatic impairment Patients with mild and moderate hepatic impairment can use Striverdi Respimat at the recommended dose.

There are no data available for use of Striverdi Respimat in patients with severe hepatic impairment. Renal impairment Renally impaired patients can use Striverdi Respimat at the recommended dose. There is limited experience with the use of Striverdi Respimat in patients with severe renal impairment.

Paediatric population There is no relevant use of Striverdi Respimat in the paediatric population (under 18 years). Method of administration This medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat re-usable inhaler.

Respimat is an inhaler device that generates a spray for inhalation. It is meant for use by a single patient and intended for multiple doses delivered by one cartridge. The Respimat re-usable inhaler allows for replacement of the cartridge, and can be used with up to 6 cartridges.

Patients should read the instructions on how to use the Respimat re-usable inhaler before they start using Striverdi Respimat. To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health care professional.

Instructions for handling and use of the Respimat re-usable inhaler The patient will need to use this inhaler only ONCE A DAY. Each time used take TWO ACTUATIONS (PUFFS). • If Striverdi Respimat has not been used for more than 7 days release one actuation (puff) towards the ground.

• If Striverdi Respimat has not been used for more than 21 days repeat steps 4 to 6 under ‘Prepare for use’ until a cloud is visible. Then repeat steps 4 to 6 three more times. How to care for the Respimat re-usable inhaler Clean the mouthpiece including the metal part inside the mouthpiece with a damp cloth or tissue only, at least once a week.

a. Summary of the safety profile Many of the listed undesirable effects can be assigned to the anticholinergic properties of tiotropium bromide or to the ß2-adrenergic properties of olodaterol, the components of Spiolto Respimat b. e.

events attributed to Spiolto Respimat) observed in the tiotropium 5 microgram/olodaterol 5 microgram dose group (5646 patients), pooled from 8 active or placebo-controlled, parallel group clinical trials in COPD patients with treatment periods ranging between 4 and 52 weeks.

Adverse reactions reported in all clinical trials with Spiolto Respimat are shown below according to system organ class. These also include all adverse reactions previously reported with one of the individual components.

Frequency 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), not known (cannot be estimated from the available data) System Organ Class Adverse reaction Frequency Infections and infestations Nasopharyngitis not known Metabolism and nutrition disorders Dehydration not known Dizziness uncommon Insomnia rare Nervous system disorders Headache uncommon Vision blurred rare Glaucoma not known Eye disorders Intraocular pressure increased not known Atrial fibrillation rare Tachycardia uncommon Palpitations rare Cardiac disorders Supraventricular tachycardia rare Vascular disorders Hypertension rare Cough uncommon Dysphonia uncommon Laryngitis rare Pharyngitis rare Epistaxis rare Bronchospasm rare Respiratory, thoracic and mediastinal disorders Sinusitis not known Dry mouth uncommon Constipation rare Oropharyngeal candidiasis rare Gingivitis rare Nausea rare Intestinal obstruction Ileus paralytic not known Dysphagia not known Gastrooesophageal reflux disease not known Glossitis not known Stomatitis rare Gastrointestinal disorders Dental caries not known Hypersensitivity rare Angioedema rare Urticaria rare Pruritus rare Anaphylactic reaction not known Rash rare Skin infection and skin ulcer not known Skin and subcutaneous tissue disorders, Immune system disorders Dry skin not known Arthralgia rare Back pain1 rare Musculoskeletal and connective tissue disorders Joint swelling rare Urinary retention rare Urinary tract infection rare Renal and urinary disorders Dysuria rare 1 undesirable effects reported with Spiolto Respimat, but not with the individual components c.

Asthma Striverdi Respimat should not be used in asthma. The long-term efficacy and safety of olodaterol in asthma have not been studied. e. as rescue therapy. Hypersensitivity As with all medications, immediate hypersensitivity reactions may occur after administration of Striverdi Respimat.

Paradoxical bronchospasm As with other inhaled medicines Striverdi Respimat may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs Striverdi Respimat should be discontinued immediately and alternative therapy substituted.

g. 44 s), and in patients who are unusually responsive to sympathomimetic amines. Patients with a history of myocardial infarction during the previous year, unstable or life-threatening cardiac arrhythmia, hospitalized for heart failure during the previous year or with a diagnosis of paroxysmal tachycardia (>100 beats per minute) were excluded from the clinical trials.

Therefore the experience in these patient groups is limited. Striverdi Respimat should be used with caution in these patient groups. Cardiovascular effects Like other beta2-adrenergic agonists, olodaterol 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, treatment may need to be discontinued. In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave and ST segment depression, although the clinical significance of these observations is unknown.

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), which may increase the susceptibility to cardiac arrhythmias. Hyperglycaemia Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose. Anaesthesia Caution needs to be taken in case of a planned operation with halogenated hydrocarbon anaesthetics due to an increased susceptibility to the adverse cardiac effects of beta agonist bronchodilators.

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