くすりのしおり

Internal
Revised: 3/2018

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 granules 1% [Autosomal dominant polycystic kidney disease]
 Active ingredient:
Tolvaptan
 Dosage form:
pale blue granules
 Print on wrapping:

Effects of this medicine

This medicine inhibits the action of vasopressin in the kidney and slows the cyst growth rate.
It is usually used to slow the progression of rapidly enlarging autosomal dominant polycystic kidney disease in which the kidneys have already become enlarged.

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 impaired fluid intake, hypernatremia, renal disorder, liver dysfunction or a history thereof, including chronic hepatitis and drug-induced liver dysfunction, coronary artery disease, cerebrovascular disease, hyperkalemia, hyponatremia, or dehydration symptom.
  • 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, start with 6 g (60 mg of the active ingredient) a day in 2 divided doses, 4.5 g (45 mg) in the morning and 1.5 g (15 mg) in the evening. Take 60 mg a day for 1 week or longer. If you show tolerability (if you are able to continue treatment), the dose will be increased stepwise at intervals of at least 1 week, first to 9 g (90 mg: 6 g [60 mg] in the morning and 3 g [30 mg] in the evening) a day and then to 12 g (120 mg: 9 g [90 mg] in the morning and 3 g [30 mg] in the evening) per day. The dosage may be adjusted according to the tolerability, but it should not exceed 12 g (120 mg) a day. In the evening, take the medicine 4 hours before going to bed to avoid frequent urination during the night. 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 enough water to prevent dehydration. Drink 1 or 2 glasses of water before going to bed and drink water whenever you urinate during the night. Always try to drink water as frequently as possible.
  • 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 syncope and dizziness and caution is therefore required to avoid falling accidents. In particular, you should refrain from 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 periodic hepatic function tests and 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, polydipsia 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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