くすりのしおり

External
Revised: 12/2014

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 18mcg
 Active ingredient:
Tiotropium bromide hydrate
 Dosage form:
bright green opaque capsule (diameter: approx. 6.0mm, length: approx. 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.
It is usually used for the remission of various symptoms of airway obstruction caused by chronic bronchitis or pulmonary emphysema. This medicine should be inhaled regularly every day and is not used to relieve rapidly acute worsening of symptoms.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have angle closure glaucoma, difficulty in urination due to prostate hypertrophy.
  • If you are pregnant or 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))
  • In general, for adults, inhale 1 capsule (18 mcg of tiotropium) at a time, once a day with the special inhalation device (HandiHaler). Strictly follow the instructions.
  • Remove 1 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 this 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 corneal edema.
  • If you miss an inhalation, inhale as soon as you remember. 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 experience any change in symptoms during the missed inhalation period, consult with your doctor or pharmacist. Do not take more than one dose (2 inhalations) in 24 hours.
  • If you accidentally inhale more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop inhaling this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include thirst/dry mouth, irritation of throat, cough, rash, dizziness, constipation and indigestion. If any of these symptoms occur, consult with your doctor or pharmacist.
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.
  • orthopnea (breathing more easily when sitting up straight rather than lying down), palpitation, chest pain [heart failure, atrial fibrillation, extrasystoles]
  • bloating sensation, nausea, vomiting, constipation [ileus]
  • blurred vision, eye pain, headache, bloodshot eye [angle closure glaucoma]
  • pharyngeal edema, hives, angioedema, dyspnea [anaphylaxis]
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 reach of children. Store away from direct sunlight and moisture and store at 25℃ or below. Do not freeze.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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