くすりのしおり

Internal
Revised: 10/2018

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 :
SAMSCA Tablets 15mg [Volume overload in heart failure]
 Active ingredient:
Tolvaptan
 Dosage form:
blue tablet, diameter: 8 mm, thickness: 3.1 mm
 Print on wrapping:
(Front) サムスカ錠, Otsuka, 15mg (Back) サムスカ錠15mg

Effects of this medicine

This medicine acts on the kidneys and resolves swelling of the body by increasing the urine output and removing unnecessary fluids.
It is usually used in combination with other diuretics when the other diuretics alone do not show sufficient effect.

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 are unable to sense thirst or have anuria, impaired fluid intake, hypernatremia, hepatic encephalopathy, coronary artery disease, cerebrovascular disease, hyperkalemia, or renal disorder.
  • If you are pregnant, possibly 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 (15 mg of active ingredient), once daily. In order to avoid nocturnal urination, it is desirable to take the medicine in the morning. Your doctor may decide to start the medicine at half dose (7.5 mg of active ingredient) or to later reduce the dose to half according to your age or symptoms. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as you remember it. However, if it is close to the time for the next dose, skip the missed dose and continue 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

  • If you feel thirst, drink an appropriate amount of water to prevent dehydration but be careful not to drink an excessive amount.
  • This medicine increases both urine volume and urination frequency and should therefore be used with caution.
  • Women of childbearing potential should use contraception to avoid pregnancy while taking this medicine. Contact your doctor immediately if you discover that you are pregnant while on this medicine.
  • This medicine may cause dizziness and caution is therefore required to avoid falling accidents. In particular, you should pay sufficient attention when working in high places or operating potentially hazardous machinery, including motor vehicles, while on this medicine.
  • Avoid taking this medicine with grapefruit juice since it may enhance the effect of this medicine.
  • Avoid taking this medicine with health foods containing Hypericum perforatum (St. John's wort) since it may reduce the therapeutic effect of this medicine.
  • As frequent serum sodium concentration measurements are necessary while on this medicine, follow the instructions of your doctor.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include thirst, dizziness, frequent urination, excessive urination, headache, and constipation. 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.
  • decrease of urine output, swelling, thirst [renal failure]
  • localized pain, pressured pain, erythema [thromboembolism]
  • mental confusion and hyperventilation, dehydration symptoms such as thirst, decreased consciousness (in serious cases, coma) [hypernatremia]
  • general malaise, loss of appetite, yellowing in skin and white of eyes [acute hepatic failure, liver dysfunction]
  • decreased blood pressure, hives, respiratory distress [shock, anaphylaxis]
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 away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask your pharmacist or medical institution about how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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