くすりのしおり

Internal
Revised: 10/2020

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 :
CHAMPIX Tablets 1mg
 Active ingredient:
Varenicline tartrate
 Dosage form:
pale blue tablet, major axis: 10 mm, minor axis: 5 mm, thickness: 4 mm
 Print on wrapping:
チャンピックス1mg, CHAMPIX1mg, CHX1.0

Effects of this medicine

This medicine shows a partial agonist effect (stimulating and antagonistic actions) by binding to α4β2 nicotine receptors in the brain instead of nicotine. It helps to decrease withdrawal symptoms due to smoking cessation and desire to smoke by enhancing a small amount of free-dopamine with the stimulating action. It also suppresses a feeling of satisfaction due to smoking by inhibiting the binding of nicotine to α4β2 nicotine receptors with the antagonistic action when you smoke while taking this medicine.
It is usually used for helping smokers with nicotine addiction to quit smoking.

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: mental disorders such as schizophrenia/bipolar disorder/depression or renal dysfunction.
    If you are on hemodialysis.
  • 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 with taking 0.5 mg of varenicline at a time, once a day after meals on the first to third day. For from the forth to the seventh day, take 0.5 mg at a time, twice a day after breakfast and supper. After the eighth day, take 1 mg at a time, twice a day after breakfast and supper. Medication period should be 12 weeks. This preparation contains 1 mg of varenicline in a tablet. Strictly follow the instructions.
  • Consult with your doctor and set a date for starting smoking cessation. Then, start this medicine from 1 week before the date and continue the treatment for 12 weeks.
  • If you do not tolerate the dosage, it may be decreased to 0.5 mg of varenicline at a time. Also, if you have any severe renal dysfunction, start with taking 0.5 mg at a time, once a day. Then, the dose frequency may be increased up to twice a day, as necessary.
  • 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 follow 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

  • Various symptoms (e.g. depressive feeling, impatience, anxiety) accompanied with smoking cessation have been reported whether treatment is conducted or not. If you have any mental disorder, the symptom may worsen during medication.
  • This medicine may cause dizziness, sleepiness or consciousness disorder and there is a case resulted in car accident. Do not operate dangerous machinery such as driving a car.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, insomnia, abnormal dream, headache, bloat, constipation, gastritis and vomiting. If any of these symptoms occur, consult with your doctor or pharmacist.
This medicine may cause various symptoms such as depressed mode, anxiety, impatience, excitement, change in behavior or thought, mental disorder, shift in mood, becoming aggressive, having hostile feelings and suicidal thought. If you have any of these symptoms during medication, stop taking this medicine and consult with your doctor.
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.
  • skin eruption, fever, skin redness [Stevens-Johnson syndrome, erythema multiforme]
  • swelling of the face/tongue/lips/throat, hives, breathing difficulty [angioedema]
  • decreased consciousness, impaired mind, decreased judgement [consciousness disorder]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver dysfunction, jaundice]
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 and moisture.
  • Discard the remainder. Do not store them. If you dispose of unused medicines, ask the pharmacy 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.

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