くすりのしおり

Internal
Revised: 10/2015

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 :
REMINYL Oral Solution 4mg/mL(2mL of divided pack)
 Active ingredient:
Galantamine hydrobromide
 Dosage form:
clear, colorless solution
 Print on wrapping:
(Face) レミニール内用液4mg/mL, 8mg/2mL, 2mL, (Back) Reminyl 2mL, JP116

Effects of this medicine

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

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 or 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 convulsive disorders such as epilepsy or a history of such disorders, 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 taking this medicine at dosage of 4 mg of galantamine at a time, twice a day, and 4 weeks later, the dosage will be increased up 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. This preparation contains 2 mL (8 mg of galantamine) in a pack. Strictly follow the instructions.
  • This medicine should be taken after a meal wherever possible in order to lessen adverse reactions.
  • 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 dementia of the Alzheimer type, 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, be attentive to your body weight changes.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, vomiting, loss of appetite, diarrhea, decreased appetite 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.
  • fainting, shortness of breath, dizziness [syncope, bradycardia, heart block, QT prolonged]
  • fever, red skin rash, small rash resulting from blister containing pus [acute generalized exanthematous pustulosis]
  • 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 reach of children. Store away from direct sunlight, heat, moisture and freezing.
  • 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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