くすりのしおり

External
Revised: 10/2020

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 :
Atectura low dose inhalation capsules
 Active ingredient:
Indacaterol acetate
Mometasone furoate
 Dosage form:
colorless and transparent inhalation capsule, major axis: 16.0 mm, minor axis: 5.8 mm
 Print on wrapping:
アテキュラ低用量

Effects of this medicine

This medicine is a combination inhaler of β2 receptor agonists and corticosteroids to keep asthma symptoms less likely to occur by reducing airway inflammation and dilating bronchi over a long period.
It is usually used to treat bronchial asthma.
It is designed to be routinely inhaled every day. Therefore, it does not provide prompt relief of acute progression (asthma attack) of the 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 infection, deep mycosis, or diabetes mellitus.
  • 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 at a time, once a day, with using special inhaler (Atectura Breezhaler) at a regular time every day . Strictly follow the instructions.
  • Never take the capsule orally; it should be used only for inhalation.
  • Take out the capsule from the aluminum package (blister package) immediately before using it.
  • Read the instruction leaflet for users thoroughly before using this medicine. (Japanese version only)
  • To prevent oral candidiasis and/or hoarse voice, gargle after inhaling. (If gargling is difficult, rinse out your mouth.)
  • If you miss a dose, inhale the missed dose as soon as possible. However, do not use it more than once a day. 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 using 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 dysphonia and muscle spasms. 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.
  • breathing difficulty, hives, cold sweat [anaphylaxis]
  • weakness, muscle weakness, paralysis of limbs [reduction in serum potassium level]
  • palpitation, dizziness, syncope (faint) [atrial fibrillation]
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, heat and moisture.
  • Discard any remaining medicine. Do not store.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.