くすりのしおり

External
Published: 1/2017

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 1.25mcg 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 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, 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 2 puffs (2.5 mcg of tiotropium) at a time, once a day. Strictly follow the instructions.
  • 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).
  • 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 eye bloodshot or eye-ache associated with conjunctival congestion or corneal edema.
  • If you miss a dose, inhale the missed dose 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 follow 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

  • 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, palpitations, supraventricular tachycardia and irritation of 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 straight rather than 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 and moisture. Do not freeze.
  • 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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