Usage
Ø Warn patient not to exceed maximum recommended dose (2 inhalations/ day).2
Ø If SPIOLTO RESPIMAT has NOT been used for more than 7 days, release one puff towards the ground.1
Ø If SPIOLTO RESPIMAT has NOT been used for more than 21 days, prime until a cloud is visible.1
Ø When the dose indicator enters the red area of the scale, approximately medication for 7 days left (14 puffs).1
Ø Once the dose indicator reaches the end of the red scale, no more doses can be release.1
Ø SPIOLTO RESPIMAT should be discarded three months after have prepared for first use, even if it has not been used or used at all.1
Special
warnings/ Precautions
v NOT indicated for treatment of acute episodes of bronchospasm / exacerbation, i.e. NOT as rescue therapy.1-3
v Patients should be advised that dizziness and blurred vision have been reported with the use of SPIOLTO RESPIMAT. Caution should be recommended when driving a car or operating machinery.1,3
v Avoid activities requiring
mental alertness or coordination until drug effects are realized.2
v Side effects may include nasopharyngitis, epistaxis, pharyngitis, sinusitis, cough, back pain, rash, constipation, urinary retention or dry mouth.2
v Dry mouth, which has been observed with anti-cholinergic treatment, may in the long term be associated with dental caries.1,3
v Avoid getting spray into the eyes:
o As this may result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary blurring of vision.1
o Should this occur, immediately flush your eyes with cold tap water for several minutes, stop using Spiolto Respimat and immediately consult your doctor for further advice.4
o Eye symptoms may be accompanied by headache, nausea or vomiting.4
v Warn patient to report symptoms of paradoxical bronchospasm, worsening COPD, or decreased efficacy of the drug.2
v Stop using Spiolto Respimat and tell your doctor immediately if you get sudden tightness of the chest, coughing, wheezing or breathlessness immediately after using the Spiolto Respimat.4
v Tell your doctor as soon as possible if you notice any symptoms of hypokalaemia (low level of potassium in blood), such as muscle spasm, muscle weakness or abnormal heart rhythm.4
v If you are a smoker, you should stop smoking - unless you are on medication such as warfarin or theophylline, where you may need to discuss your intention to reduce / stop smoking with your doctor first.4
A good example of patient’s information leaflet with diagrams is available from the following website: https://www.medsafe.govt.nz/Consumers/cmi/s/spioltorespimat.pdf
Cleaning
· Clean the mouthpiece including the metal part inside the mouthpiece with a damp cloth or tissue only, at least once a week. Make sure no water entry into internal part(s) of the inhaler. 4
· It is important to keep your inhaler clean and dry. It may not work as well if it gets dirty.4
References:
1. Product leaflet, Spiolto Respimat Inhalation Solution 2.5 mcg / 2.5 mcg
per actuation [Revised 20 Mac 2017]
2. Micromedex, version 2.5b851: Tiotropium 2.5 mcg & Olodaterol 2.5
mcg
3. MIMSGATEAWAY [online]: Spiolto Respimat
4. https://www.medsafe.govt.nz/Consumers/cmi/s/spioltorespimat.pdf
All info are accessed on 26 Oct 2020
Prepared by Syahmi ; Edited by J. Ho on 26 Oct 2020
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