くすりのしおり

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Published: 12/2016

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 :
Spiolto Respimat 60 puffs
 Active ingredient:
Tiotropium bromide hydrate
Olodaterol hydrochloride
 Dosage form:
inhalation
 Print on wrapping:

Effects of this medicine

This medicine is a combination of a long-acting muscarinic receptor antagonist and a long-acting β2-receptor agonist, which suppresses bronchoconstriction and opens up the bronchial tubes to ease breathing and to make such symptoms as shortness of breath less liable to occur.
It is usually used to relieve symptoms of airway obstructive disorder in chronic obstructive pulmonary disease (chronic bronchitis, emphysema). It is a medicine to be regularly taken by oral inhalation every day but is not intended to promptly relieve worsening of any acute 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, impaired urination due to prostatic hypertrophy and others, heart disorder, decreased kidney function, convulsive disorder, diabetes mellitus or hyperthyroidism.
  • 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 2 puffs at a time, once daily. Strictly follow the instructions on inhalation.
  • Read the instruction for users "How to inhale Spiolto Respimat" thoroughly before using the medicine.
  • Inhale the dose just around the same time every day wherever possible.
  • Excessive use of this medicine may entail the risk of adverse reactions such as arrhythmia and cardiac arrest. Do not inhale this medicine more often than once a day.
  • Pay attention not to get this medicine in your eyes. If you accidentally get some in your eyes, wash it off thoroughly with water. Should red eye or eye pain associated with conjunctival hyperemia or corneal edema occur, consult with an eye doctor as soon as possible.
  • If you miss a dose, inhale the missed dose as soon as possible. However, if you do not have an inhalation device and/or this medicine in hand or if it is almost time for your next dose, skip the missed dose and follow your regular dosing schedule. In case of any symptomatic change occurring while missing a dose, nevertheless, consult with your doctor or pharmacist. You should never inhale two doses at one time.
  • 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

  • When you are taking an inhaled short-acting β2-agonist during treatment with this medicine, use the β2-agonist solely for the purpose of relieving acute respiratory symptoms such as acute bronchospasm.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include dry mouth. 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 than when lying down), palpitation, chest pain [heart failure, atrial fibrillation, extrasystoles]
  • abdominal enlarged feeling, nausea/vomiting, constipation [ileus]
  • reduced visual acuity, eye pain, headache, eye bloodshot [angle closure glaucoma]
  • pharyngeal edema, hives, angioedema, respiratory distress [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, heat, moisture and freezing.
  • Discard the remainder. Do not store them. Follow the disposal method prescribed by the local government.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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