くすりのしおり

Internal
Published: 6/2020

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 OD Tablets 15mg [Hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH)]
 Active ingredient:
Tolvaptan
 Dosage form:
blue tablet, diameter: 8 mm, thickness: 3.1 mm
 Print on wrapping:
(Front) サムスカOD, Otsuka, 15mg, OD (Back) サムスカOD錠15mg

Effects of this medicine

This medicine acts on the kidneys and increases blood sodium concentration by increasing the urine output and removing unnecessary fluids.
It is usually used to treat hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH).

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 half tablet (7.5 mg of active ingredient), once a day, increasing the dose stepwise until a desirable level of serum sodium concentration is achieved, if necessary. Although the dose may be adjusted as needed according to your condition, it must not exceed the maximum daily dose of 4 tablets (60 mg). 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 3.75 mg of active ingredient or to later reduce the dose to 3.75 mg of active ingredient according to your condition. Strictly follow the instructions.
  • You may swallow this medicine with saliva after soaking the tablet with saliva on the tongue and crushing it gently with the tongue. You may also take this medicine with a cup of cold or lukewarm water.
  • You should not take this medicine without water while in a lying-down position.
  • 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.
  • You should take a predetermined amount of water. After discontinuation of this drug, drink fluids according to your doctor's direction.
  • 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, etc. 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 headache, dizziness, thirst, constipation, liver dysfunction, frequent urination, excessive urination, fatigue and excessive drinking. 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]
  • paralysis of limbs, unclear articulation, difficulty in swallowing, convulsion, loss of consciousness, confused consciousness [rapid increase in serum sodium concentration, osmotic demyelination syndrome]
  • general malaise, loss of appetite, yellow discoloration of skin and/or conjunctiva [acute hepatic failure, liver dysfunction]
  • dizziness on standing up, 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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