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 "Maruishi"
 Active ingredient:
Tramadol hydrochloride
Acetaminophen
 Dosage form:
pale yellow tablet, major axis: 15.6 mm, minor axis: 6.4 mm, thickness: 5.1 mm
 Print on wrapping:
(face) トアラセット配合錠「マルイシ」, トラマドール塩酸塩37.5mg, アセトアミノフェン325mg, トアラセット配合錠, 疼痛治療剤, トラマドール・アセトアミノフェン配合錠, (back) TOARASET"Maruishi", 疼痛治療剤, トアラセット配合錠「マルイシ」, トラマドール塩酸塩37.5mg, アセトアミノフェン325mg, トラマドール・アセトアミノフェン配合錠

Effects of this medicine

This medicine acts on the central nervous system to exert its analgesic effect.
It is usually used to treat chronic non-cancer pain and post tooth extraction pain that are refractory to treatment 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 have acute intoxication with an alcoholic beverage, hypnotic, analgesic, opioid analgesic or psychotropic agent.
    If you are within 14 days after stopping monoamine oxidase inhibitor medication.
    If you have epilepsy (not adequately managed by treatment), peptic ulcer, blood abnormality, liver disorder, renal disorder or cardiac function failure.
    If you have or have a history of aspirin asthma (asthma attack induced by non-steroid agent).
    If you are a habitual heavy drinker.
    If you have glutathione deficiency or dehydration due to fasting/poor nutritional condition/eating 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))
  • Chronic non-cancer pain: In general, for adults, take 1 tablet at a time, 4 times a day. Wait more than 4 hours to take the next dose. The dosage may be adjusted according to the symptoms. The maximum dose is 2 tablets at a time, 8 tablets a day. Avoid taking this medicine on an empty stomach.
    Post tooth extraction pain: In general, for adults, take 2 tablets at a time. In the case you take additional dose(s), wait more than 4 hours to take the next dose. The maximum dose is 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. However, 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/loss of consciousness. Avoid performing dangerous operations such as driving a car. There are cases in which loss of consciousness resulted in car accidents.
  • Alcohol (drinking) may make respiratory depression or hepatic adverse reactions more likely to occur. Refrain from drinking alcohol while taking this medicine.
  • Do not take other medicines containing tramadol or acetaminophen (including OTC drugs) while taking this medicine, since tramadol/acetaminophen overdose may occur.
  • If you take high-doses (> 4 tablets a day) of this medicine for a long period, liver function test may be regularly conducted. Keep all appointments/laboratory test schedules.

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.
  • respiratory distress, wheezing, hives [shock, anaphylaxis]
  • convulsion [convulsion]
  • loss of consciousness [loss of consciousness]
  • unable to stop taking the medicine; symptoms such as trembling of limbs/insomnia/anxiety/convulsion/hallucination occur when you stop taking the medicine [dependence]
  • fever, red rash/blister on skin, conjunctival hyperemia [toxic epidermal necrolysis, muco-cutaneo-ocular syndrome, acute generalized exanthematous pustulosis]
  • general malaise, loss of appetite, yellowing of skin and the white of eyes [fulminant hepatitis, liver dysfunction, jaundice]
  • breathing becomes shallow and fast, difficult to breathe [respiratory depression]
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 the pharmacist and the medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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