くすりのしおり

Internal
Published: 5/2016

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 :
AMLODIPINE OD TABLETS 5mg" ZE "
 Active ingredient:
Amlodipine besilate
 Dosage form:
pale orange tablet, diameter: 8.0mm, thickness: 3.4mm
 Print on wrapping:
(face)ZE26, アムロジピンOD5mg「ZE」, 5mg
(back)AMLODIPINE OD 5mg「ZE」, アムロジピンOD5, アムロジピンOD錠「ZE」, 5mg

Effects of this medicine

This medicine lowers the blood pressure and prevents/relieves episode of angina by reducing the flow of calcium into the cell and relaxing smooth muscles of peripheral/coronary vessels.
It is usually used to treat hypertension and angina.

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: low blood pressure, liver dysfunction or kidney dysfunction.
  • 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))
  • For the treatment of hypertension: In general, for adults, take 1/2 to 1 tablet (2.5 to 5 mg of amlodipine) once a day. The dose may be adjusted according to your symptoms. If the dose seems to be insufficient, the dose may be increased up to 2 tablets (10 mg of amlodipine) once a day. For children 6 years or older, take 1/2 tablet (2.5 mg of amlodipine) once a day. The dose may be adjusted according to the age, body weight, symptoms, but the maximum dosage is 1 tablet (5 mg of amlodipine) per day.
    For the treatment of angina: In general, for adults, take 1 tablet (5 mg of amlodipine) once a day. The dose may be adjusted according to your symptoms.
    In any case, strictly follow the instructions.
  • The medicine is designed to be taken without water. Crush it slightly with the tongue and swallow with saliva.
    Alternatively, it can be taken with a glass of water/lukewarm water like other general medicines.
  • If you are a patient with hypertension, you do not have to take the missed dose on that day. Continue your regular dosing schedule from the following day. If you are a patient with angina, take the missed dose as soon as possible. However, if there are less than about 8 hours before 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

  • This medicine may cause dizziness due to decreased blood pressure. Pay close attention to working at the high place, operating dangerous machinery, such as driving a car.
  • Do not take grapefruit juice and the medicine together as it may intensify the effect of the medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include glow (heat sensation, glow on the face, etc.), dizziness/lightheadedness, headache/dull headache, palpitation, rash, itch, hives, excess sun tan/itch/pigment deposition caused by sunlight, circular/oval red rash, fever, joint pain, rash or purple/red bruise on the arm/foot, general dullness, swelling/hives on the eyelid/lip/tongue, respiratory distress (caused by swollen airways), and gum hyperplasia. 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.
  • general malaise, yellowing of the skin and the white of eyes, loss of appetite [fulminant hepatitis, liver dysfunction, jaundice]
  • sore throat, fever, nose/gum bleeding [agranulocytosis, leukopenia, thrombocytopenia]
  • bradycardia, dizziness, faint [atrioventricular block]
  • muscle pain, lassitude, reddish brown urine [rhabdomyolysis]
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 the pharmacist or medical institution how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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