Download Drug Information Sheet("Kusuri-no-Shiori") Internal Published: 09

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 09/2015
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:PROPACIL Tablet 50mg
Active ingredient:Propylthiouracil
Dosage form:white tablet (φ: 7.2mm, thickness: 3.5mm)
Print on wrapping:(face) プロパジール 50mg, プロパジール, 50mg
(back) PROPACIL 50mg, プロパジール 50mg, プロパジール, 50mg
Effects of this medicine
This medicine works on thyroid gland to block the activity of enzyme which is necessary for thyroid hormone
synthesis, consequently to suppress excess secretion of thyroid hormone.
It is usually used to treat hyperthyroidism.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reaction (itch, rash etc.) to any medicines.
If you are a patient with hepatic disorder, leukopenia, or other blood disease.
・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>>
・For adults: In general, take the initial dosage of 6 tablets (300mg of the active ingredient) in 3-4 divided doses a
day. To treat severe hyperthyroidism, take 8-12 tablets (400-600mg of the active ingredient) a day. When
hyperthyroid symptoms almost disappear, the dosage will be tapered every 1-4 week(s). The maintenance dosage
is 1-2 tablet(s) (50-100mg of the active ingredient) in 1-2 divided doses a day.
For children: In general, for children aged 5 or over but under 10, take the initial dosage of 2-4 tablets (100-200mg
of the active ingredient) in 2-4 divided doses a day. For children aged 10 or over but under 15, take the initial
dosage of 4-6 tablets (200-300 mg of the active ingredient) in 2-4 divided doses a day. When hyperthyroid
symptoms almost disappear, the dosage will be tapered every 1-4 week(s). The maintenance dosage is 1-2 tablet(s)
(50-100 mg of the active ingredient) in 1-2 divided doses a day.
For pregnant women: In general, take the initial dosage of 3-6 tablets (150-300 mg of the active ingredient) in 3-4
divided doses a day. When hyperthyroid symptoms almost disappear, the dosage will be tapered every 1-4 week(s).
The maintenance dosage is 1-2 tablet(s) (50-100 mg of the active ingredient) in 1-2 divided doses a day. In order
not to let your thyroid function level get down than that during normal pregnancy, you should undergo the test
every 2 weeks and take the least amount of the medicine possible.
It should be adjusted according to your age and symptoms in any case. Strictly follow the instructions.
・If you missed a 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. However, you should never take two doses at one time.
・If you accidentally took more than your prescribed dose, consult with your doctor or pharmacist.
・The medicine takes time to work. Discontinuing it half way will lead to an aggravated condition or recurrence of the
disease. Neither stop taking the medicine nor increase the dosage on your own. And keep taking it according to
the instructions of your doctor.
Precautions while taking this medicine
・Your doctor will examine your thyroid gland condition and decide the appropriate dosage for you based on the result
from it. Also, you will be examined periodically to detect its side effect in early stages. Do not forget to see your
doctor and undergo the test.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash, urticaria and fever. 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.
・fever, sore throat, lassitude [agranulocytosis, leukopenia]
・dizziness, nose/gum bleeding, palpitation/shortness of breath when going upstairs or uphill, palpitation, shortness
of breath, blue spot, continuous bleeding [aplastic anemia]
・nose/gum bleeding, blue spot, subcutaneous bleeding, bleeding tendency, continuous bleeding
1/2
[hypoprothrombinemia, anti hemophilic factor VII deficiency, thrombocytopenia, thrombocytopenic purpura]
・yellowness in the skin and/or the white of the eye, dark/brown urine, loss of appetite, nausea, vomiting, fever,
headache, impaired judgment/mind, loss of consciousness, flapping tremor in hands [fulminant hepatitis, jaundice]
・butterfly-like red punctum on the face, fever, muscle pain, joint pain, swollen lymph nodes, lassitude, upper
abdominal pain [systemic lupus erythematosus (SLE)-like symptom]
・breathlessness, shortness of breath, fever, dry cough [interstitial pneumonia]
・fever, joint pain, breathlessness, rash, subcutaneous bleeding, headache, numbness/paralysis, bloody urine, anemia
[antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis syndrome]
・itch, urticaria, hoarseness, breathlessness, sneeze, palpitation, decreased/confused consciousness [Anaphylaxis]
・chills, lightheadedness, heavy sweating, fever, faint consciousness, impaired mind/ judgment, breathlessness, itch,
rash, numbness [drug-induced hypersensitivity syndrome]
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 in a covered container, at room temperature (1-30℃). Keep away from
light and moisture.
・Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
2/2