くすりのしおり

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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 :
GALANTAMINE OD TABLETS 8mg "NIPRO"
 Active ingredient:
Galantamine hydrobromide
 Dosage form:
faint red to pale red tablets, diameter: 7.1 mm, thickness: 2.9 mm
 Print on wrapping:
(Face)ガランタミンOD8mg「ニプロ」, ガランタミン, 8mg, OD
(Back)GALANTAMINEOD8mg「NIPRO」, ガランタミン, 8mg, OD, 「ニプロ」

Effects of this medicine

This medicine prevents decrease of acetylcholine, a neurotransmitter in the brain, via inhibiting the action of catabolic enzyme and by facilitating nerve signals. It delays progression of dementia symptoms such as memory impairment (forgetfulness), disorientation (problems in cognition of time and place) and difficulty in making judgments.
It is usually used for inhibiting progression of Alzheimer-type dementia symptoms.

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 sick sinus syndrome, heart diseases such as sinoatrial block and atrioventricular block, a history of gastric ulcer/duodenal ulcer, gastrointestinal obstruction, lower urinary tract obstruction, Parkinsons disease or Parkinson syndrome.
    If you are in a condition just after an operation on the digestive tract or on the urinary bladder.
    If you have or have a history of convulsive disorders such as epilepsy, a history of bronchial asthma or obstructive lung disease, liver disorder or renal disorder.
  • 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, start by giving 4 mg of galantamine at a time, twice a day, and 4 weeks later, the dosage will be increased to 8 mg at a time, twice a day. The dosage may be increased up to 12 mg at a time, twice a day, according to symptoms, however, in the case of dosage increase, the increase will be made only after this medicine has been administered for 4 weeks or longer at the preceding dose level. Strictly follow the instructions.
  • This medicine should be taken after a meal as much as possible in order to lessen adverse reactions.
  • This medicine can be given with water like normal tablets, or without water. Let the patient moisten the tablet with saliva on the tongue, then crush it lightly with the tongue and swallow it with saliva. Do not let the patient take the tablet without water when he/she is lying down.
  • If you miss giving a dose, give the missed dose as soon as possible. However, if several hours has already passed since the scheduled time, skip the missed dose and follow your regular dosing schedule. You should never give two doses at one time.
  • If you accidentally give more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop giving this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • In patients with Alzheimer-type dementia, the ability to drive a car and to operate machinery diminishes gradually and the use of this medicine may cause dizziness and sleepiness. Therefore, pay attention when operating dangerous machinery such as driving a car.
  • As weight loss may occur, pay attention to change in your body weight.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, vomiting, diarrhea, loss of appetite, anemia, headache, dizziness, abdominal pain, constipation, upper abdominal pain, gastric distress, dull, rash, itch, facial edema, agitation, loss of consciousness, convulsion and fever. 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.
  • faint, shortness of breath, dizziness [syncope, bradycardia, heart block, QT prolonged]
  • fever, red skin rash, small rash resulting from blister containing pus [acute generalized exanthematous pustulosi]
  • loss of appetite, malaise, nausea [hepatitis]
  • 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. Seek advice of your pharmacy or medical institutions about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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