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SPIOLTO RESPIMAT is a brand name for Olodaterol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Spiolto Respimat is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler. Two puffs from the Respimat inhaler comprise one medicinal dose. Adults The recommended dose is 5 microgram tiotropium and 5 microgram olodaterol given as two 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 Spiolto Respimat at the recommended dose. Hepatic impairment and Renal impairment Spiolto Respimat contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver.
Hepatic impairment Patients with mild and moderate hepatic impairment can use Spiolto Respimat at the recommended dose. There are no data available for use of olodaterol in patients with severe hepatic impairment. Renal impairment Renally impaired patients can use Spiolto Respimat at the recommended dose.
2. Spiolto Respimat contains olodaterol. There is limited experience with the use of olodaterol in patients with severe renal impairment. Paediatric population There is no relevant use of Spiolto 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 Spiolto 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 PUFFS. • If Spiolto Respimat has not been used for more than 7 days release one puff towards the ground. • If Spiolto Respimat has not been used for more than 21 days repeat steps 4 to 6 under ‘Prepare for use’ until a cloud is visible.
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 Skin and subcutaneous tissue disorders, Immune system disorders Rash rare Skin infection and skin ulcer not known 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 Spiolto Respimat should not be used in asthma. The efficacy and safety of Spiolto Respimat in asthma have not been studied. e. as rescue therapy. Paradoxical bronchospasm As with other inhaled medicines Spiolto Respimat may result in paradoxical bronchospasm that may be life-threatening.
If paradoxical bronchospasm occurs Spiolto Respimat should be discontinued immediately and alternative therapy substituted. Anticholinergic effects related to tiotropium Narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction Consistent with the anticholinergic activity of tiotropium, Spiolto Respimat should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.
Eye symptoms Patients should be cautioned to avoid getting the spray into their eyes. They should be advised that this may result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema.
Should any combination of these eye symptoms develop, patients should stop using Spiolto Respimat and consult a specialist immediately. Dental caries Dry mouth, which has been observed with anti-cholinergic treatment, may in the long term be associated with dental caries.
Patients with renal impairment As plasma concentration of tiotropium increases with decreased renal function in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) Spiolto Respimat should be used only if the expected benefit outweighs the potential risk.
2). Cardiovascular effects The experience with Spiolto Respimat is limited in 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) because these patients were excluded from the clinical trials.
1. g. ipratropium or oxitropium.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. Any minor discoloration in the mouthpiece does not affect the Respimat re-usable inhaler performance.
If necessary, wipe the outside of the Respimat re-usable inhaler with a damp cloth. When to replace the inhaler When the patient has used an inhaler with 6 cartridges, get a new Spiolto Respimat pack containing an inhaler. Do not use the Respimat re-usable inhaler for more than one year, after having inserted the first cartridge.
Prepare for use 1. Remove clear base • Keep the cap closed. • Press the safety catch while pulling off the clear base with the other hand. 2. Insert cartridge • Insert the cartridge into the inhaler. • Place the inhaler on a firm surface and push down firmly until it clicks into place.
3. Track cartridge and put the clear base back • Mark the check-box on inhaler’s label to track the number of cartridges. • Put the clear base back into place until it clicks. 4. Turn • Keep the cap closed. • Turn the clear base in the direction of the arrows on the label until it clicks (half a turn).
5. Open • Open the cap until it snaps fully open. 6. Press • Point the inhaler toward the ground. • Press the dose-release button. • Close the cap. • Repeat steps 4-6 until a cloud is visible. • After a cloud is visible, repeat steps 4-6 three more times.
The inhaler is now ready to use and will deliver 60 puffs (30 doses). Daily use TURN • Keep the cap closed. • TURN the clear base in the direction of the arrows on the label until it clicks (half a turn). OPEN • OPEN the cap until it snaps fully open.
PRESS • Breathe out slowly and fully. • Close the lips around the mouthpiece without covering the air vents. Point the Inhaler to the back of the throat. • While taking a slow, deep breath through the mouth, PRESS the dose-release button and continue to breathe in slowly for as long as comfortable.
• Hold the breath for 10 seconds or for as long as comfortable. • Repeat TURN, OPEN, PRESS for a total of 2 puffs. • Close the cap until the inhaler is used again. When to replace the Spiolto Respimat cartridge The dose indicator shows how many puffs remain in the cartridge.
60 puffs remaining. Less than 10 puffs remaining. Obtain a new cartridge. The cartridge is used up. Turn the clear base to loosen it. The inhaler is now in a locked position. Pull off the cartridge from the inhaler. Insert a new cartridge until it clicks (refer to step 2).
The new cartridge will stick out more than the very first cartridge (continue with step 3). Remember to put the clear base back to unlock the inhaler.
Description of selected adverse reactions Spiolto Respimat combines anticholinergic and ß2-adrenergic properties due to its components tiotropium and olodaterol. 7% and 1% in the tiotropium 5 microgram and olodaterol 5 microgram arms, respectively.
04%) treated with Spiolto Respimat. Serious undesirable effects consistent with anticholinergic effects include glaucoma, constipation, intestinal obstruction including ileus paralytic and urinary retention. ß-adrenergic adverse reaction profile Olodaterol, one component of Spiolto Respimat is a member of the therapeutic class of long-acting beta2-adrenergic agonists.
Therefore the occurrence of other undesirable effects related to the beta-adrenergic agonist class, which are not listed above, should be taken into consideration, such as, arrhythmia, myocardial ischaemia, angina pectoris, hypotension, tremor, nervousness, muscle spasms, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis.
d. Other special populations An increase in anticholinergic effect may occur with increasing age. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Spiolto Respimat should be used with caution in these patient groups. 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.
g. 44 s), and in patients who are unusually responsive to sympathomimetic amines. 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. Spiolto Respimat should not be used in conjunction with any other medications containing long-acting beta2-adrenergic agonists.
g. four times a day) should be instructed to use them only for symptomatic relief of acute respiratory symptoms. Spiolto Respimat should not be used more frequently than once daily. Hypersensitivity As with all medications, immediate hypersensitivity reactions may occur after administration of Spiolto Respimat.
Excipients Benzalkonium chloride may cause wheezing and breathing difficulties. Patients with asthma are at an increased risk for these adverse events.