くすりのしおり

External
Revised: 3/2021

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 :
Ultibro inhalation capsules
 Active ingredient:
Glycopyrronium Bromide
Indacaterol Maleate
 Dosage form:
yellow transparent/colorless and transparent inhalation capsule, major axis: 15.8 mm, minor axis: 5.6 mm
 Print on wrapping:
ウルティブロ, IGP110.50

Effects of this medicine

This medicine is a combination inhaler of muscarinic receptor antagonist and β2 receptor agonists to improve respiratory function by dilating bronchi over a long time. It is designed to be routinely inhaled every day. Therefore, it does not provide prompt relief of acute progression of the symptoms.
It is usually used to induce a remission of symptoms caused by airway obstructive disorder in chronic obstructive pulmonary disease (chronic bronchitis, emphysema).

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, hyperthyroidism, heart disease, diabetes mellitus, convulsive disease, bronchial asthma, hypoxemia, renal disorder.
  • 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 (Ultibro 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.
  • Take care to prevent this medicine from getting into the eye. If conjunctival congestion, red eye due to corneal edema or eye pain occurs, see your ophthalmologist immediately.
  • If you miss a dose at the regular time, inhale a dose as soon as possible. However, do not use it more than once a day. You should never inhale two doses at one time. Consult with your doctor or pharmacist about subsequent inhalation time of this medicine.
  • If you accidentally use 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 cough, dry mouth, upper respiratory infection, headache, dysphonia and fever. 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.
  • feelings of weakness, muscular 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 the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.