くすりのしおり

Internal
Revised: 11/2013

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 :
REZALTAS COMBINATION TABLETS LD
 Active ingredient:
Olmesartan medoxomil
Azelnidipine
 Dosage form:
one surface white, one surface white to yellowish white tablet (φ: 9.7 mm, thickness: approx. 4.9 mm)
 Print on wrapping:
(upper side) レザルタス配合錠LD,レザルタスLD,DSC372,オルメサルタン メドキソミル10mg/アゼルニジピン8mg
(under side) RezaltasLD,レザルタスLD,高血圧症のお薬です,オルメサルタン メドキソミル10mg/アゼルニジピン8mg

Effects of this medicine

This medicine is a combination preparation of an angiotensin receptor blocker and a calcium antagonist. It lowers blood pressure by suppressing the vasoconstriction action of angiotensin II in vascular smooth muscles with angiotensin receptor blocker, and by dilating blood vessels with calcium antagonist.
It is usually used in the treatment of hypertension.

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 a patient with renal artery stenosis, hyperkalemia, renal disorder, hepatic disorder, cerebrovascular disorder.
  • If you are a patient on hemodialysis, or on a strict low-salt diet.
  • 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 at a time, once a day after breakfast. Strictly follow the instructions.
    The medicine contains 10 mg of olmesartan medoxomil and 8 mg of azelnidipine in 1 tablet.
  • If you miss a dose, take the missed dose as soon as possible. If it is almost 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

  • The medicine may cause dizziness or lightheadedness by decreasing blood pressure. Pay close attention when you work at heights, drive a car or operate dangerous machinery.
  • Do not drink grapefruit juice while you take the medicine because it may cause an excessive hypotensive response by increasing blood level of the medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include urticaria, rash, itch, dizziness and headache. 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.
  • breathing difficulty, swelling in the eyelids/lips/tongue, urticaria  [angioedema]
  • decreased urine output, edema, headache  [renal failure]
  • numbness in the limbs and lips, muscular weakness, paralysis in the limbs  [hyperkalemia]
  • cold feeling, vomiting, loss of consciousness  [shock, faint, loss of consciousness]
  • general malaise, anorexia, yellowing in the skin/white of eyes [hepatic dysfunction, jaundice]
  • nasal bleeding, gums bleeding, subcutaneous bleeding  [thrombocytopenia]
  • cold sweat, hungry feeling, lassitude  [hypoglycemia]
  • dizziness, lightheadedness  [atrioventricular block, sinus arrest, bradycardia]
  • muscle pain, losing strength, red-brown urine [rhabdomyolysis]
  • itch, general redness, blood pressure falling, breathing diffichlty [anaphylaxis]
  • mud-like or water-like stool, weight loss [severe diarrhea]
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 the reach of children. Store away from light, 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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