くすりのしおり

Internal
Published: 12/2015

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 :
RALOXIFENE HYDROCHLORIDE Tablets 60mg "SAWAI"
 Active ingredient:
Raloxifene hydrochloride
 Dosage form:
white tablet, major axis: 12.2 mm, minor axis: 6.6 mm, thickness: 4.5 mm
 Print on wrapping:
ラロキシフェン塩酸塩60 mg「サワイ」, 骨粗しょう症の薬, Raloxifene Hydrochloride 60 mg「SAWAI」

Effects of this medicine

This medicine acts in the same way that a female hormone (estrogen) does after menopause and suppresses bone resorption, resulting in increased bone density and resistance to fractures.
It is usually used to treat postmenopausal osteoporosis.

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 venous thromboembolism and a history of it.
    If you are in a state of prolonged immobilization.
    If you have antiphospholipid antibody syndrome.
  • If you are pregnant, breastfeeding or possibly pregnant.
  • 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 (60 mg of the active ingredient) at a time, once a day. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. 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 abdominal bloating, nausea, dermatitis, itch, breast engorgement, cramps of lower limbs, hypoesthesia, peripheral edema, hot flush and heavy sweating. 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.
  • pain/edema of lower limbs, sudden respiratory distress, rapid reduced visual acuity [venous thromboembolism (deep vein thrombosis, pulmonary embolism, retinal vein thrombosis)]
  • general malaise, loss of appetite, yellow discoloration 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 the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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