Download Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 07

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 07/2016
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:VONOSAP Pack 400
Active ingredient:Vonoprazan fumarate
Clarithromycin
Amoxicillin hydrate
Dosage form:1. Takecab Tablets 20mg: faint red elliptical tablet, major diameter: 11.2
mm, minor diameter: 6.2 mm, thickness: about 3.9 mm. 2. Clarith tab. 200:
white tablet, diameter: about 8.6 mm, thickness: about 5.4 mm. 3. AMOLIN
CAPSULES 250: capsule with white cap and white body, major diameter:
18.8 mm, minor diameter: 6.3 mm.
Print on wrapping:(Face) ボノサップパック 400, 1 日 2 回（朝, 夕）, 7 日間続けて服用し
て下さい (Back) ボノサップパック 400 の服用方法
Effects of this medicine
Takecab Tablets 20mg inhibits gastric mucosal proton pump to suppress gastric acid secretion, thereby enhancing
the antibacterial effects of the antibiotics (Clarith tab. 200 and AMOLIN CAPSULES 250), while Clarith tab. 200 and
AMOLIN CAPSULES 250 demonstrate their antibacterial effects against Helicobacter pylori.
It is usually used to treat Helicobacter pylori infection of gastric ulcer, duodenal ulcer, gastric MALT lymphoma,
idiopathic thrombocytopenic purpura or the stomach after endoscopic treatment of early-stage gastric cancer, and to
treat Helicobacter pylori gastritis.
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 infectious mononucleosis, renal disorder, heart disease or liver disorder.
If you or any of your parents and siblings is predisposed to allergic symptoms such as bronchial asthma and rash.
If you are in a poor oral feeding state.
・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 of Takecab Tablets 20mg (20 mg of vonoprazan), 1 tablet of Clarith tab. 200
(200 mg [titer] of clarithromycin) and 3 capsules of AMOLIN CAPSULES 250 (750 mg [titer] of amoxicillin
hydrate) at a time, twice a day, for 7 days. The dosage of Clarith tab. 200 may be increased as required but the
maximum daily dose is 2 tablets (400 mg [titer] of of clarithromycin) at a time, twice a day. This medicine is
supplied in pack sheets. Each sheet contains one morning and one evening doses (good for one day) (each dose: 1
tablet of Takecab Tablets 20mg, 1 tablet of Clarith tab. 200 and 3 capsules of AMOLIN CAPSULES 250). Strictly
follow the instructions.
・If you miss a dose, take the missed dose as soon as possible. However, if it is less than 5 hours to the time for your
next 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
These medicines may cause gastrointestinal symptoms such as diarrhea, taste abnormality or rash. Take the following
measures according to symptoms.
1) In case of gastrointestinal symptoms such as loose stool and mild diarrhea or taste abnormality
Continue taking this medicine to complete the dosing schedule (7 days); do not reduce dosage or the number of
medication at your discretion.
If symptoms become worsened, however, consult with your doctor or pharmacist.
2) In case of diarrhea associated with fever or abdominal pain, mucus- and/or blood-containing diarrhea or rash
Stop taking this medicine immediately and contact your doctor or pharmacist.
The most commonly reported other adverse reactions include stomatitis, stomach discomfort, abdominal enlarged
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feeling, itching, constipation, edema, fever, nausea, loss of appetite, vomiting, gastric distress, abdominal pain,
hallucination, disorientation (inability to be cognizant of time, location or name), consciousness disorder, delirium,
mania, shivering, numbness, tinnitus, decreased hearing, olfactory abnormality, oral erosion, tooth discoloration,
muscle pain, candidiasis, palpitation and hypoglycemia. 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.
・ill feeling, diaphoresis, breathing difficulty, rash, facial edema, convulsion [shock, anaphylaxis]
・general malaise, fever, shortness of breath, nose bleeding/subcutaneous bleeding, reddish brown urine [decreased
platelets, pancytopenia, hemolytic anemia, decreased white blood cell, agranulocytosis, decreased granulocyte
count]
・yellowing of the skin and the white of eyes, general malaise, loss of appetite [liver dysfunction, jaundice, liver failure,
fulminant hepatitis]
・fever, headache, arthralgia, rash/redness of the skin, eyes and oral cavity, tenseness/burning sensation/pain of the
skin [toxic epidermal necrolysis, muco-cutaneo-ocular syndrome, acute generalized exanthematous pustulosis,
erythema multiforme, erythroderma]
・fever, dry cough, breathing difficulty [PIE syndrome, interstitial pneumonia, eosinophilic pneumonia]
・decreased urine output, edema of the face and limbs, fever [acute renal failure, tubulointerstitial nephritis]
・abdominal pain, frequent diarrhea, bloody stool [colitis pseudomembranous, hemorrhagic colitis]
・chest pain, palpitation, chest discomfort [QT prolongation, ventricular tachycardia (incl. Torsades de pointes),
ventricular fibrillation]
・lassitude, muscle pain, brown urine [rhabdomyolysis]
・convulsion [convulsion]
・purpura [allergic purpura]
・rash, fever [drug-induced hypersensitivity syndrome]
・nuchal rigidity, fever, headache, nausea/vomiting [meningitis aseptic]
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.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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