tely.
• shortness of breath, respiratory distress, fever [interstitial lung disease]
• muddy or watery stool, abdominal pain, dehydration [severe diarrhea]
• acne-like rash, pain/heat sensation/redness/swelling around nails [severe dermopathy]
• general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver dysfunction]
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 pharmacist and the
medical institution how to discard them.
Internal
Published: 02/2019
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.
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VIZIMPRO Tablets 45mg
Brand name:VIZIMPRO Tablets 45mg
Active ingredient:Dacomitinib hydrate
Dosage form:blue tablet, diameter: approx. 9.0mm, thickness:
approx. 4.5mm
Print on wrapping:VIZIMPRO, ビジンプロ, 45mg, DCB 45
Effects of this medicine
This medicine suppresses tumor growth by inhibiting active mutated epidermal growth factor receptor (EGFR)
tyrosine kinase.
It is usually used to treat EGFR mutation positive inoperable or recurrent non-small cell lung cancer.
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: interstitial lung disease or its history and liver dysfunction.
• 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 1 tablet (45 mg of dacomitinib) at a time, once a day. The dosage may be decreased
according to the condition. Strictly follow the instructions.
• If you miss a dose, skip the missed dose and follow your regular dosing schedule. 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
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, paronychia, stomatitis (oral ulceration, aphthous
ulcer, etc.), acneiform dermatitis and rash/ maculopapular rash/ erythematous eruption. If any of these symptoms
occur, consult with your doctor or pharmacist.
The symptoms descri |
