くすりのしおり

Internal
Revised: 10/2020

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 :
Tramal OD Tablets 50mg
 Active ingredient:
Tramadol hydrochloride
 Dosage form:
white tablet, diameter: 10.0 mm, thickness: 4.1 mm
 Print on wrapping:
トラマールOD錠50mg, 50, 133, Tramal OD Tab. 50mg

Effects of this medicine

This medicine relieves severe pain by binding to opioid receptor and inhibiting reuptake of monoamine.
It is usually used to treat cancer pain and chronic pain that is non-responsive to 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 caused by alcohol, sleeping pills, painkiller, opioid pain reliever or psychotropic drug or epilepsy with inadequate therapeutic management.
    If you have used other drug(s) within the past 2 weeks.
  • 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 100 to 300 mg of the active ingredient a day, in 4 divided doses. The dosage may be adjusted according to the symptoms. The maximum dose is 100 mg at a time, 400 mg a day. In case of acute worsening of pain, take 1/8 to 1/4 of your regular daily dose at a time as a rescue dose (for cancer pain). This preparation contains 50 mg of the active ingredient in a tablet. Strictly follow the instructions.
  • You can take this medicine without water. Wet the tablet with saliva on the tongue and crush it lightly, and then swallow it with saliva. You can also take it with water like regular tablets.
  • Do not take the tablet without water when you are lying down.
  • 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. 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 sleepiness, dizziness or loss of consciousness. There has been cases reported that loss of consciousness resulted in car accidents. Avoid operating dangerous machinery, such as driving a car.
  • Since alcohol drinking may intensify medicinal or medical effects and adverse reactions, avoid drinking during medication.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include constipation, nausea, vomiting, somnolence, loss of appetite, dizziness, headache, dry mouth and malaise. 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 (whistling breath), swelling around the eyes and lips [shock, anaphylaxis]
  • decrease in breathing, breathing difficulty [respiratory depression]
  • sudden muscle contraction [convulsion]
  • unable to stop using the medicine, sleeplessness, anxiety [dependence]
  • loss of consciousness [unconsciousness]
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 reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. If you dispose of unused medicines, ask the pharmacy 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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