くすりのしおり

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Revised: 4/2021

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 2.5mcg Respimat 60 puffs
 Active ingredient:
Tiotropium bromide hydrate
 Dosage form:
inhalation
 Print on wrapping:

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 to relieve symptoms of airway obstructive disorder in chronic obstructive pulmonary disease (chronic bronchitis, emphysema) or bronchial asthma. 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 or impaired 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 2 puffs (5 mcg of tiotropium) at a time, once a day. Strictly follow the instructions on inhalation.
  • Read the instruction for users “how to inhale Spiriva Respimat” thoroughly before using the medicine.
  • If your symptoms worsen because of insufficient effect of the inhalation, visit a medical institution as soon as possible (e.g., when using this medicine for bronchial asthma or when using higher frequency of short-acting β2 agonist than usual).
  • 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 using for bronchial asthma, do not stop using the medicine suppressing inflammation of airway (e.g., inhaled corticosteroid) based on your judgment that this medicine has improved your symptoms.
  • When using for bronchial asthma, this medicine should be used with inhaled corticosteroids. Gargling after inhalation is recommended.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include dry mouth, hoarseness (hoarse voice), rash, itching, hives, dizziness, palpitation, supraventricular tachycardia and irritation in the throat. 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 lying down), palpitation, chest pain [heart failure, atrial fibrillation, extrasystole]
  • abdominal bloating, nausea/vomiting, constipation [ileus]
  • reduced visual acuity, eye pain, headache, eye bloodshot [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, 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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