くすりのしおり

Internal
Revised: 8/2019

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 :
Amlodin Tablets 5mg
 Active ingredient:
Amlodipine besilate
 Dosage form:
white tablet, diameter: approx. 8 mm, thickness: approx. 3.5 mm
 Print on wrapping:
(face) アムロジン, 5 mg
(back) Amlodin 5 mg, アムロジン, 5 mg, #536

Effects of this medicine

This medicine lowers the blood pressure and prevents/relieves episode of angina by reducing the flow of calcium ion 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 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 0.5 to 1 tablet (2.5 to 5 mg of amlodipine) once a day. If the dose seems to be insufficient, the dose may be increased up to 2 tablets (10 mg of amlodipine) once a day. The dose may be adjusted according to your symptoms. For children 6 years or older, take 0.5 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. Strictly follow the instructions.
    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. Strictly follow the instructions.
  • 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 took 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

  • You may feel dizziness/lightheadedness due to decreased blood pressure. Therefore pay close attention when driving a car, working at heights or operate dangerous machinery while taking this medicine.
  • 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 edema, glow (heat sensation, facial glow, 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 of 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, loss of appetite, yellowness in the skin and the conjunctiva [fulminant hepatitis, hepatic dysfunction, jaundice]
  • sore throat, headache, nose/gum bleeding [agranulocytosis, leukopenia, thrombocytopenia]
  • bradycardia, faint, dizziness [atrioventricular block]
  • pain of the limb muscle, stiffness, numbness [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 and the medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.