くすりのしおり

Internal
Revised: 3/2007

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 :
TIGASON Capsule 10
 Active ingredient:
Etretinate
 Dosage form:
pale red-brown/pale red-white capsule (major axis: approx. 14.5mm)
 Print on wrapping:
チガソン10mg

Effects of this medicine

This medicine makes abnormally stiffened part on the skin and the oral mucosa easy to peel off and re-forms normal surface skin and mucosa. It is usually used to treat serious psoriasis and ichthyosis.

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

  • If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
    If you are a patient with hepatic/renal disorder or hypervitaminosis A.
    If you are predisposed to have hypertriglyceridemia. (For example, you have diabetes, obesity, alcoholism or lipid metabolism abnormality.)
  • 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: For adults, in order to induce a remission, take 40-50mg of the active ingredient in 2-3 divided doses a day for 2-4 weeks. The maximum daily dosage is 75mg of the active ingredient. After that, in order to maintain remission, take 10-30mg of the active ingredient in 1-3 divided doses a day according to the patient's symptoms.
    For infants and children, in order to induce a remission, take 1.0mg/kg of the active ingredient in 1-3 divided doses a day for 2-4 weeks. After that, in order to remain remission, take 0.6-0.8 mg/kg of the active ingredient in 1-3 divided doses a day according to the patient's symptoms.
    It should be adjusted according to your disease, age and symptoms in any case.
    1 capsule contains 10mg of the active ingredient. Strictly follow the instructions of your doctor/pharmacist.
  • Avoid taking this medicine with a great amount of milk or fatty food.
  • 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. 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

  • This medicine has teratogenic potential (possibility to cause fetal anomaly) and has a higher incidence of side effects. You need to be informed of the side effects until you fully understand them.
  • In using this medicine, you need to be informed of precautions mentioned below until you fully understand them. If you agree to them, sign the letter of consent.
  • If you have a possibility of pregnancy, you have to wait a few days after your menstruation begins before taking this medicine. Also, you may have a pregnancy test within 2 weeks before taking this medicine.
  • If you have a possibility of pregnancy, make sure to avoid pregnancy during use and for at least 2 years after withdrawal of this medicine.
  • A male patient must avoid pregnancy during use and for at least 6 months after withdrawal of this medicine.
  • You cannot make a blood donation during use and for at least 2 years after withdrawal of this medicine.
  • When you have joint/bone pain, contact your doctor immediately. Also, if you are supposed to take this medicine for a long period, you may have to take an X-ray examination, etc.
  • This medicine may cause liver damage. For the early detection of the side effects, your liver function will be checked before and 1 month after starting this medication, and also every 3 months during use. Do not forget to undergo it on each designated date.
  • A patient with hypertriglyceridemia tends to have lipid metabolism abnormality. So, blood test will be conducted to the patient.
  • This medicine may cause hair loss, cheilitis, or desquamation (peeled surface skin).
  • Avoid breastfeeding.

Possible adverse reactions to this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: cheilitis, desquamation (scurfy thing peeling off), dry mouth, thinning of the skin, pruritus.
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.
  • joint pain, sore red skin, red spots and breakable blisters all over the body, lassitude [toxic epidermal necrosis (Lyell syndrome)]
  • rash and blister, joint pain, fever [erythema multiforme]
  • angialgia, purple bruise, swelling [vasculitis]
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 at room temperature (1-30℃), away from light and moisture.
  • 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.

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