くすりのしおり

Internal
Revised: 9/2006

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 :
Amnolake Tablets 2mg
 Active ingredient:
Tamibarotene
 Dosage form:
white tablet, diameter 7mm, thickness 3mm
 Print on wrapping:
(face) 402, (back) アムノレイク錠 2mg

Effects of this medicine

This medicine has therapeutic action to differentiate myeloid cell.
It is used to treat relapsed or refractory acute promyelocytic leukemia.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you ever experienced any allergic reaction (itch, rash, etc.) to any medicines.
    Woman who has a possibility of being pregnant, or getting pregnant.
    If you are patient with hypervitaminosis A, hyperlipemia, disorders in liver/kidney, or reduced gastric acid secretion.
    If you are elderly patient, or 25 years or under.
  • 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))
  • General dosage regimen: Take 6mg/m2 in 2 divided doses a day after breakfast and dinner. This tablet contains 2mg of the active ingredient. Strictly follow the instructions of dosage regimen.
  • Swallow the medicine without breaking this tablet into small pieces or chewing.
  • If you missed a dose, skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose.
  • If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
  • Do not stop taking this medicine without the instructions of your doctor.

Precautions while taking this medicine

  • Woman make sure to avoid pregnancy for at least 1 month before starting this medication, during taking this medicine and for at least 2 years after discontinuing it.
  • Man make sure to avoid pregnancy during taking this medicine, and for at least 6 month after discontinuing it.
  • Note that the grapefruit juice might strengthen the action of this medicine.
  • Note that St. John's wort-containing food might weaken the action of this medicine.
  • If you are taking vitamin A product (Chocola A etc.) or fibrate drug, tell your doctor/pharmacist before using this medicine.

Possible adverse reactions to this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist:
rash, bone pain, fever, dry skin, etc.
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.
  • high fever of over 38℃, chest pain, breathlessness [retinoic acid syndrome]
  • cold-like symptoms, lassitude, vomiting [infection]
  • fever, dry cough, breathlessness [interstitial lung disease]
  • fever, chest pain, swallowing difficulty [mediastinitis]
  • muscle pain of the hands and feet, stiffness, numbness, lassitude, red/brown urine  [rhabdomyolysis]
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 baby and children. Store away from direct sunlight, high temperature and humidity.
  • Pay close attention to storage, not to lose this medicine.
  • Do not share this medicine with any other person, and make sure that any other person do not take it by mistake.
  • Discard the remainder. Do not store them. Ask the pharmacist how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.