Drug Information Sheet("Kusuri-no-Shiori")
External
Revised: 03/2011
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,
patients should understand their medication and cooperate with the treatment.
Brand name:Spiriva Inhalation Capsules 18μg
Active ingredient:Tiotropium bromide hydrate
Dosage form:bright green opaque capsule (diameter: 6.0mm, length: 16mm)
Print on wrapping:(Face) TI01, Spiriva 18μg, 4 カプセル, 3 カプセル, company logo,
のまないこと(Do not swallow).
(Back) スピリーバ 18μg, recycle mark, のまないこと(Do not
swallow). 止める切らない(Stop/Do not cut).
Effects of this medicine
This medicine is a muscarinic receptor antagonist with an inhibitory effect on bronchoconstriction. The resulting
bronchodilation facilitates breathing and relieves shortness of breath.
Usually, this medicine is used for the remission of various symptoms of airway obstruction caused by chronic
bronchitis or pulmonary emphysema.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have ever had any unusual or allergic reaction (itch, rash etc.) to any medicines.
If you have glaucoma, difficulty in urination due to prostate hypertrophy.
・If you are already pregnant or are breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal
effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is<<
to be written by a healthcare professional>>
・General dosage regimen: For adults, one capsule (18μg of tiotropium bromide hydrate) is inhaled once daily with
the special inhalation device (HandiHaler). Follow your doctor's instructions for inhalation method.
・Remove one capsule from the blister (aluminum sheet) immediately before inhalation. Separate the blister strips
(aluminum sheet) by tearing along the perforation.
・Do not swallow the capsule but inhale it from the special inhalation device (HandiHaler), because this medicine is
inhalation capsules.
・Be careful not to get the medicine into your eyes. If it reaches the eyes, rinse with clean water immediately. Please
see a doctor(ophthalmologist) if you notice bloodshot eyes or eye-ache associated with conjunctival congestion or
cornea edema.
・If you missed an inhalation, inhale the medicine as soon as possible. If you do not have the inhalation device and the
medicine on hand or it is almost time for the next inhalation, skip the missed dose and continue your regular dosing
schedule. However, if you experienced any change in symptoms during the missed inhalation period, check with
your doctor/pharmacist. DO NOT inhale a double dose to make up for the missed dose.
・If you inhaled too much of this medicine, check with your doctor/pharmacist immediately.
・Do not stop your medication without the instructions of your doctor.
Precautions while taking this medicine
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: thirst/dry
mouth, irritation of throat, cough, rash, dizziness, constipation, indigestion, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated
in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
・shortness of breath, generalized edema and breathing more easily when sitting up straight rather than lying down
[heart failure]
・heart pounding, dizziness, syncope (loss of consciousness) [atrial fibrillation]
・abnormal sensation in the chest, heart pounding, chest pain [extrasystoles]
・bloating sensation, nausea, vomiting, intractable constipation [ileus]
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・blurred vision, eyepain, headache, bloodshot eye [angle closure glaucoma]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your
doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
・Keep out of the reach of children. Store away from direct sunlight and moisture and store at 25℃ or below. Do not
freeze.
・Discard unused medicine.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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