Download Drug Information Sheet("Kusuri-no-Shiori") External Revised: 05

Drug Information Sheet("Kusuri-no-Shiori")
External
Revised: 05/2012
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:Nicotinell TTS 20
Active ingredient:Nicotine
Dosage form:light orange circular patch, φ: 51 mm
Print on wrapping:CG FEF
Effects of this medicine
This medicine releases nicotine to be absorbed through the skin gradually, and relieves the desire to smoke, irritation
or loss of concentration in quitting smoking. It consequently leads to smoking cessation smoothly.
It is usually used for aid to smoking cessation of smokers with an underlying disease such as heart or respiratory
disease, who are diagnosed of requiring smoking cessation by the physician and have a strong will of it.
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 a non-smoker.
If you are a patient with unstable angina, myocardial infarction within 3 months after onset, arrhythmia, those just
after percutaneous transluminal coronary angioplasty or coronary arterial bypass grafting.
If you are in the early recovery stage of cerebrovascular disorder.
If you are planning of electric defibrillation (cardioversion; electric shock therapy), diathermy (high frequency
therapy) or MRI (magnetic resonance imaging).
・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>>
・In general, apply one patch at a time, once a day for 24 hours. The medicine is usually used in combination with
other preparation of different content (Nicotinell TTS 30/TTS 10). In normal treatment schedule (use Nicotinell
TTS 30 for the first 4 weeks, follow by Nicotinell TTS 20 for the next 2 weeks and Nicotinell TTS 10 for the last 2
weeks), use the medicine for 2 weeks after using TTS 30. The dosing period should not exceed 10 weeks. Strictly
follow the instructions.
・Take out the patch by cutting the white inner sachet with scissors. Wipe to clean the area of the skin before
patching. Apply the patch to the skin on your upper arm, abdomen or lower back. Avoid an area with injury, skin
disease, lots of body hair, or places where a belt may adhere. Press the patch firmly about 10 seconds by your palm
or fingers with making sure not to wrinkle the skin and peel the edge of the patch.
・When you apply it after taking bath, remove moisture to dry the area before patching.
・You should apply the new patch once a day. Do not apply it repeatedly on the same area.
・Do not cut the patch for using.
・If you missed a dose, apply a patch as soon as possible when you remembered that you missed a dose, and continue
your regular dosing schedule. You should never take two doses at one time.
・If you accidentally used more than your prescribed dose, remove immediately the patch and consult with your
doctor or pharmacist.
・Do not stop using this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
・DO NOT smoke while using this medicine, since excessive nicotine may be taken into the body and cause overdose
symptoms such as headache, dizziness or nausea.
・Remove the medicine before taking a sauna and exercising hard.
・If you have a fever, it may cause increasing nicotine absorption and lead to overdose.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include erythema (skin rash, redness), rash, itching, sleeplessness,
primary irritant contact dermatitis (swelling, etc.), headache, nightmare and strange dream. If any of these symptoms
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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.
・hives, breathing difficulty, angioedema(swelling in eyelid/lips/tongue) [anaphylactoid symptoms]
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
・Strictly keep out the reach of children. Store away from direct sunlight, heat and moisture. Doses of nicotine that
are tolerated by adult smokers can produce severe poisoning symptoms in small children and may proven fatal.
・Discard the remainder. Do not store them. Even used medicine has risk if children handle it. Fold the used patch in
half with the sticky sides together. Put it in the sachet taken out the new patch, and discard away from reach of
children.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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