くすりのしおり

Internal
Published: 12/2018

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 :
TOARASET COMBINATION TABLETS "KYOSOMIRAI"
 Active ingredient:
Tramadol hydrochloride
Acetaminophen
 Dosage form:
pale yellow tablet, major axis: 15.2 mm, minor axis: 6.4 mm, thickness: 5.1 mm
 Print on wrapping:
(Face)トアラセット配合錠「共創未来」, トアラセット配合錠, トラマドール, アセトアミノフェン, 37.5 mg, 325 mg, 疼痛治療剤
(Back)TOARASET Combination「KYOSOMIRAI」, トアラセット配合錠「共創未来」, 37.5mg トラマドール, 325mg アセトアミノフェン

Effects of this medicine

This medicine shows analgesic effects by acting on the central nervous system.
It is usually used to treat chronic non-cancer pain and pain after tooth extraction, that are difficult to treat with non-opioid analgesics.

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 are a habitual heavy drinker.
    If you have acute intoxication with alcohol/hypnotics/analgesics/opioid analgesics or psychotropics.
    If you have stopped taking monoamine oxidase inhibitors within 14 days.
    If you have epilepsy not adequately controlled by treatment, peptic ulcer, abnormality of the blood, liver disorder, renal disorder or cardiac function failure.
    If you have or have a history of aspirin asthma.
  • 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))
  • For chronic non-cancer pain: In general, for adults, take 1 tablet at a time, 4 times a day. Wait at least 4 hours to take the next dose. The dosage may be adjusted according to the symptoms. However, the maximum dose should not exceed 2 tablets at a time, 8 tablets a day. Avoid taking this medicine on an empty stomach.
    For pain after tooth extraction: In general, for adults, take 2 tablets at a time. Wait at least 4 hours to take an additional dose, and the maximum dose should not exceed 2 tablets at a time, 8 tablets a day. Avoid taking this medicine on an empty stomach.
    In any case, strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • This medicine may cause drowsiness, dizziness or loss of consciousness. Avoid operating dangerous machinery, such as driving a car. There have been reports of cases in which loss of consciousness caused car accidents.
  • Drinking alcohol intensifies medicinal effects, and may result in respiratory depression. Pay close attention to avoid drinking alcohol while taking this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, vomiting, somnolence, constipation and dizziness. 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.
  • pale face, cold sweat, breathing difficulty [shock, anaphylaxis]
  • muscle spasmodically contracting [convulsion]
  • loss of consciousness [unconsciousness]
  • unable to stop using a medicine and dependent on it [dependence]
  • red spots, fever, rash with pus-filled blister [toxic epidermal necrolysis, muco-cutaneo-ocular syndrome, acute generalized exanthematous pustulosis]
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. Ask your pharmacy or medical institution on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.