くすりのしおり

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Published: 12/2014

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 :
Flutiform 50 Aerosol 120 puffs
 Active ingredient:
Fluticasone propionate
Formoterol fumarate hydrate
 Dosage form:
Inhaled aerosol, sky blue line and sky blue letters on the label
 Print on wrapping:
フルティフォーム50エアゾール120吸入用

Effects of this medicine

This medicine is a combination inhaler that contains a steroid used to suppress inflammation in the airways and a long-acting bronchodilator used to dilate bronchi over a long time.
It is usually used in the treatment of bronchial asthma. It is not effective for sedating an asthma attack which has already developed.

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: infections, deep mycosis, tuberculosis, hyperthyroidism, hypertension, cardiac disease, diabetes, hypokalemia or hepatic 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, take two inhalations of the medicine (Flutiform 50 Aerosol) at a time, twice daily. Depending on the symptoms, the medicine can be replaced with "high-dose" Flutiform 125 Aerosol. Strictly follow the specified instructions.
  • Read carefully the instruction leaflet "To Patients Using Flutiform".
  • Shake the inhaler immediately before using.
  • An inhaler can be sprayed for 120 puffs. If the inhaler is new or it has not been used for more than 3 days then it must be sprayed 4 times in the air before using. When you press the aluminum canister, the dose counter on an adapter works automatically and shows green, yellow and finally red in response to use. Confirm the counter every day. When this is getting near to red, you should contact your doctor for a replacement inhaler. When this is getting to zero, you should use a new inhaler.
  • Gargle the throat after inhaling. If you are hard to gargle, rinse out your mouth.
  • If you miss a dose, inhale a dose as soon as possible when you remember that you missed a dose. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. 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 experience an asthma attack, take prescribed medicine for stopping an attack, or visit your doctor or a healthcare facility as soon as possible.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include hoarseness (hoarse voice), palpitations, asthma, stomatitis, pharyngitis, rash and hives. 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.
  • dyspnea, generalized flushing, hives [shock, anaphylaxis]
  • lassitude, loss of muscular strength, paralysis of the limbs [serious decreases in serum potassium levels]
  • fever, cough, phlegm [pneumonia]
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

  • Do not detach the inner aluminum canister from the adapter.
  • Wipe well outside and inside of mouthpiece with dry cloth or tissue paper at least once or more a week to avoid clogging of a spray outlet, and keep the device clean. Keep the aluminum canister dry.
  • Keep out the reach of children. Store it at a temperature of lower than 30℃, away from direct sunlight, heat and moisture.
  • Do not store the remainder and discard it. Follow the instruction on how to dispose of aluminum canister specified by local authorities after using. Do not throw the aluminum canister into the fire.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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