Drug Information Sheet ("Kusuri-no-Shiori")
613990072
Revised: 03/2007
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here.
Brand name： TIGASON Capsule 10
Active ingredient： Etretinate
Dosage form： pale red-brown/pale red-white capsule (major axis: approx.
14.5mm)
Printings 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, tell your doctor/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 using any other prescription or nonprescription (OTC) medicine. (It is important to reduce
the risk of drug interactions.)
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:≪
:order of your doctor≫
・ 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.
・ Missed 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. DO NOT take a double dose to make up for
the missed dose.
・ Overdose: If you took too much of this medicine (more than ordered), check with your
doctor/pharmacist.
・ Others: Do not stop taking this medicine without the instructions of your doctor.
Continued on next page.
TIGASON Capsule 10
Precautions while using 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.
Side effects of 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.
Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur,
stop taking your medicine and check with 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］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom.
Storage 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 doctor use only: Day
Month
Year
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert
information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices
Agency.
Drug Information Sheet ("Kusuri-no-Shiori")
613990073
Revised: 03/2007
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here.
Brand name： TIGASON Capsule 25
Active ingredient： Etretinate
Dosage form： pale red-brown/pale red-brown capsule (major axis: approx.
17.6mm)
Printings on wrapping： チガソン 25mg
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, tell your doctor/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 using any other prescription or nonprescription (OTC) medicine. (It is important to reduce
the risk of drug interactions.)
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:≪
:order of your doctor≫
・ 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 25mg 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.
・ Missed 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. DO NOT take a double dose to make up for
the missed dose.
・ Overdose: If you took too much of this medicine (more than ordered), check with your
doctor/pharmacist.
・ Others: Do not stop taking this medicine without the instructions of your doctor.
Continued on next page.
TIGASON Capsule 25
Precautions while using 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.
Side effects of 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.
Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur,
stop taking your medicine and check with 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］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom.
Storage 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 doctor use only: Day
Month
Year
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert
information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices
Agency.