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Category 2 OTC medicines

NICORETTE
ニコレット

CHARACTERISTICS

  • NICORETTE is a medicine for persons who want to quit smoking; relieves symptoms such as frustration and difficulty in concentration when quitting smoking. (It does not have an effect of making you hate smoking.)
  • In the 3 months’ period of use, this medicine leads you to quit smoking without stress, by gradually reducing the amount of smoking.
  • Do not use this medicine if you are not a smoker or do not smoke currently, because the medicine causes unfavorable effects on your body.

INDICATIONS

Relief of symptoms such as frustration (nicotine craving), difficulty in concentration, and restlessness during smoking cessation

DOSAGE AND DIRECTIONS

When you want to smoke, chew one piece at a time as slowly as 30 to 60 minutes, at intervals of a certain period of time. Use the table as a guide for daily dose. Usually, start with 4 to 12 pieces per day, and increase or decrease as needed.
However, the total daily dose should not be over 24 pieces. When you get used to quitting smoking (around 1 month), decrease the daily dose by 1 to 2 pieces per week. When the daily dose becomes 1 to 2 pieces, stop using this medicine.
Duration of use of this medicine is set as 3 months.

Guide to the starting daily dose
One dose Maximum daily dose Number of cigarettes smoked per day before quit smoking Daily dose
1 piece 24 pieces 20 cigarettes or less 4-6 pieces
21-30 cigarettes 6-9 pieces
31 cigarettes or more 9-12 pieces

Precautions regarding dosage and directions

  1. Stop smoking completely before use.
  2. Do not chew more than one piece at a time. (Nicotine overdose may occur, and symptoms such as nausea, dizziness, and abdominal pain may appear.)
  3. When the medicine tastes hot or you feel an irritating sensation, stop chewing, and rest it aside in a place such as the inside of the cheek.
  4. Do not swallow, because this medicine is a gum preparation. In addition, this medicine may stick to dentures, etc. and may cause dropping off or damage. If you have had dental treatment such as dentures, be careful while using it.
  5. Avoid using this medicine for a while after drinking coffee, a carbonated drink, etc. (Adequate effect may not be obtained.)
  6. Do not use this medicine together with inhalation or spray agents used in the mouth. (This may worsen the symptoms such as irritation of the mouth and throat, and sore throat.)

INGREDIENT

1 piece contains the following ingredient:
Nicotine 2 mg

Inactive ingredients: Ion-exchange resin, sodium bicarbonate, sodium carbonate, D-sorbitol, glycerin, talc, calcium carbonate, dibutylhydroxytoluene, l-menthol, vanillin, ethanol, flavor, and 6 other ingredients

PRECAUTIONS FOR USE

What you should NOT do

(If you do not follow the precautions listed below, your current symptoms may worsen and you may be at an increased risk of side effects.)

  1. The following persons should not use this medicine:
    1. Nonsmokers; persons who have never smoked or do not smoke currently. (Symptoms such as nausea, dizziness, and abdominal pain may appear.)
    2. Persons already using other nicotine preparations
    3. Women who are or may be pregnant
    4. Persons with severe heart disease
      1. Persons who had a heart attack (cardiac infarction) in the past 3 months
      2. Persons who have been diagnosed with severe angina
      3. Persons who have been diagnosed with severe arrhythmia
    5. Persons who have been diagnosed with acute cerebrovascular disorder (such as cerebral infarction and cerebral hemorrhage)
    6. Persons who have been diagnosed with depression
    7. Persons who have had allergies (such as rashes, redness, itching, and edema) to this medicine or ingredients of this medicine
    8. Persons with a jaw joint disorder
  2. Do not use this medicine if breastfeeding. Stop breastfeeding if using this medicine.
    (It will get transferred into breast milk, and may lead to faster pulse of the infant.)
  3. Avoid the following during or immediately after the use of this medicine:
    1. Smoking
    2. Use of a nicotine patch preparation
  4. Do not use this medicine for over 6 months.

Who should seek consultation

  1. The following persons should consult a physician, dentist, pharmacist, or registered salesperson* before using this medicine:
    1. Persons under treatment by a physician or dentist
    2. Persons using other drugs
      (It may affect the action of other drugs.)
    3. Elderly persons and persons under 20 years
    4. Persons who have had allergies to medicines or something
    5. Persons who have suffered from the following symptoms:
      Abdominal pain, chest pain, stomatitis, sore throat, swelling of the throat
    6. Persons diagnosed with the following conditions:
      Heart disease (cardiac infarction, angina, arrhythmia), cerebrovascular disorder (such as cerebral infarction and cerebral hemorrhage), Buerger's disease (peripheral vascular disorder), hypertension, thyroid dysfunction, pheochromocytoma, diabetes (persons using insulin preparations), pharynx inflammation, esophagitis, gastric and duodenal ulcer, liver disease, kidney disease. (This medicine may worsen the symptoms or affect the actions of concurrently used drugs.)
  2. Stop using this medicine immediately and consult a physician, pharmacist, or registered salesperson if the following symptoms appear after using this medicine because they might be side effects of the medicine. Take this leaflet with you.
    Affected area Symptoms
    Mouth, throat Stomatitis, sore throat
    Digestive organs Nausea, vomiting, stomach discomfort, heartburn, loss of appetite, diarrhea
    Skin Rashes, redness, itching
    Neuropsychiatric system Headache, dizziness, slowed thinking, sleepiness
    Circulatory organs Palpitations
    Others Chest discomfort, irritation of the chest, face redness, face edema, feeling ill
  3. Stop using this medicine and consult a physician, dentist, pharmacist, or registered salesperson if the following symptoms appear after using this medicine and continue or worsen. Take this leaflet with you.
    1. Irritation of the mouth and throat, roughness of the tongue, abnormal taste sensation, increased saliva, gingivitis. (These symptoms may become mild if you chew the medicine slowly.)
    2. Pain in the jaw
      (There may be other causes.)
    3. Hiccups, belching
  4. The following symptoms may appear if you accidentally use a higher dose than the designated dose of this medicine, or if children accidentally swallow this medicine. In such a case, consult a physician, pharmacist, or registered salesperson. Take this leaflet with you.
    Nausea, increased saliva, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disorder, generalized weakness (possibility of acute nicotine poisoning)
  5. If you continue to use this medicine for more than 3 months, consult a physician, pharmacist, or registered salesperson. Take this leaflet with you.
    (Nicotine dependence may occur with prolonged and heavy use of this medicine.)

*Registered salesperson: person who has the license to sell OTC medicines except Category 1.

PRECAUTIONS FOR STORAGE AND HANDLING

  1. Store in a dry, cool place away from direct sunlight. (If stored in a hot place, the gum sticks to the sheet and it becomes difficult to take it out.)
  2. This medicine has a package to prevent children from opening it easily, but keep out of the reach of children.
  3. To prevent improper use or loss of quality, do not transfer the medicine to another container.
  4. Do not use this medicine after the expiration date.
  5. After chewing, throw away the gum after wrapping it in paper, etc., in a place out of the reach of children.