くすりのしおり

External
Revised: 6/2014

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 :
Fentos Tape 8mg
 Active ingredient:
Fentanyl citrate
 Dosage form:
white patch, 6.33cm x 6.33cm
 Print on wrapping:
HP3168T

Effects of this medicine

This medicine acts on opioid receptors of the central nervous system and shows potent analgesic effect.
It is usually used for relief from persistent severe pain.

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 respiratory functional disorder such as chronic lung disease, asthma, bradyarrhythmia, hepatic/renal dysfunction, increased intracranial pressure, organic brain damage (such as consciousness disorder/coma, brain tumor etc.), or high fever with 40 degrees Celsius or more.
    If you have a history of drug dependency.
  • 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, apply a tape at a time to the chest, abdomen, upper arm, or thigh and replace a new patch everyday (every 24 hours). The starting dose will be selected from 1mg, 2mg, 4mg, or 6mg of the active ingredient, and then the dose should be adjusted according to your symptoms and status. This preparation contains 8mg of the active ingredients in a piece of tape. Strictly follow the instructions.
  • Take out the tape by ripping open a pouch without scissors but with your hands. Rip open an area where it says 〈(1)ここから開封してください ("(1) First, open here")〉, and then where it says 〈(2)つぎにこちらを開封してください ("(2) Next, open here")〉. (These instructions are written only in Japanese.)
  • Before applying the tape, dry the area with a towel to thoroughly remove moisture such as sweat. Do not apply the tape on injured skin or skin abnormality.
  • Do not apply the new tape to the same place as the last one.
  • Each tape has clear films. Fold the film lightly in half with the side where it says 〈ここからはがす ("Remove from here")〉 facing upward, and remove half of the film. (This instruction is written only in Japanese.) Take care not to touch the adhesive part with the fingers. Apply half of the tape without the film, and then apply the other half.
  • Press the tape firmly by your palm after application. Wash your hands with tap water after application.
  • If you forget to apply a tape, apply the new one as soon as possible with following the above procedure. You should never use double dosage at one time.
  • If you accidentally apply more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop applying this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • While wearing the tape, avoid exposing the tape application site to direct external heat sources, such as electric pads, electric blankets, heating pads, heated water beds, infrared heat lamps, hot-water bags, kotatsu (Japanese-style warming device) and so on. Avoid taking intensive sunbathing or saunas.
  • Avoid strenuous exercise during applying the tape.
  • If you have a fever during applying the tape, consult with your doctor.
  • This medicine may cause drowsiness or dizziness. Avoid operating machinery with potential risk such as driving a car.
  • Drinking alcohol may intensify the effects of the medicine. Avoid drinking alcohol during applying the tape.
  • Do not take a bath at a high temperature during applying the tape.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include drowsiness, itching at the application site, nausea, vomiting, constipation, and diarrhea. 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 becomes shallow and slow [respiratory depression]
  • faint consciousness, impaired mind, judgment failure [disturbed consciousness ]
  • unable to stop taking the medicine and be dependent on the subject [dependence]
  • breathing difficulty, hives, twilight state [shock, anaphylaxis]
  • convulsion [convulsion]
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 this medicine out of the reach of infants, children and pets. Store away from direct sunlight, heat and moisture.
  • Never give this medicine to anyone else.
  • The used tape should be folded in half with the sticky sides together and discarded as household waste. Put into a pouch/plastic bag and tightened a seal. (Keep it out of the reach of infants, children, and pets when discarding.)
  • Return no longer necessary tapes to your hospital or pharmacist. Ask your pharmacist or hospital about how to return.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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