添付文書

● Features
● Nicorette Ice Mint is a medicine for people who want to quit smoking, alleviating symptoms such as irritability and difficulty concentrating during smoking cessation. (It does not have the effect of making you dislike cigarettes.)
● The usage period is about 3 months, and by gradually reducing the amount used, it guides you to a manageable smoking cessation.
● Do not use if you do not smoke or are not currently smoking, as it may have adverse effects on the body.
● It is a nicotine gum formulation with a sugarless coating that is easy to chew.

【Designated Class 2 OTC Drug】

● Efficacy/Effects
Alleviation of symptoms such as irritability, difficulty concentrating, and restlessness during smoking cessation

<Precautions related to Efficacy/Effects>


● Dosage and Administration
When you feel like smoking, chew one piece slowly with intervals over 30 to 60 minutes. The daily number of pieces used should be based on the table as a guideline, usually starting with 4 to 12 pieces per day and adjusting as needed, but the total daily usage should not exceed 24 pieces. Once you get used to quitting smoking (about one month), reduce the daily number of pieces by 1 to 2 pieces each week, and stop using when the daily number reaches 1 to 2 pieces. The usage period is about 3 months.
[Single dose: Maximum daily usage: Guideline for daily usage at the start (number of cigarettes smoked per day before quitting): Guideline for daily usage at the start (daily number of pieces)]
1 piece: 24 pieces: 20 or fewer cigarettes: 4–6 pieces
1 piece: 24 pieces: 21–30 cigarettes: 6–9 pieces
1 piece: 24 pieces: 31 or more cigarettes: 9–12 pieces


<Precautions related to Dosage and Administration>
1. Use only after completely stopping smoking.
2. Do not chew more than 2 pieces at a time (excessive nicotine intake may cause symptoms such as nausea, dizziness, and abdominal pain).
3. If you feel a spicy or irritating sensation, stop chewing and rest the gum against the inside of your cheek.
4. This product is a gum formulation and should not be swallowed. Also, it may adhere to dentures and cause them to fall off or be damaged, so people who have had dental treatment such as dentures should be careful when using it.
5. Do not use this product immediately after drinking coffee or carbonated beverages (the product may not be fully effective).
6. Do not use simultaneously with inhalants or sprays used in the mouth (may worsen symptoms such as irritation in the mouth/throat and sore throat).

● Ingredients/Quantity
Per piece
Nicotine 2 mg

〔Additives〕
Ion exchange resin, xylitol, acesulfame potassium, sodium bicarbonate, sodium carbonate, magnesium oxide, talc, peppermint oil, l-menthol, calcium carbonate, dibutylhydroxytoluene (BHT), gum arabic powder, hypromellose (hydroxypropyl methylcellulose), titanium oxide, carnauba wax, polysorbate 80, sucralose, flavoring, and 9 other ingredients

<Precautions related to Ingredients/Quantity>


● Dosage Form
Gum (external use - others)

● Precautions for Use
■Do not do (Contraindications)
(If not followed, current symptoms may worsen or side effects may occur more easily)
1. Do not use if you fall under the following:
(1) Non-smokers [people who have never smoked and those who are not currently smoking] (may cause symptoms such as nausea, dizziness, and abdominal pain)
(2) People already using other nicotine products
(3) Pregnant women or those suspected of being pregnant
(4) People with severe heart disease
1) Those who have had a myocardial infarction attack within the past 3 months
2) Those diagnosed by a doctor with severe angina
3) Those diagnosed by a doctor with severe arrhythmia
(5) People diagnosed by a doctor with acute cerebrovascular disorders (cerebral infarction, cerebral hemorrhage, etc.)
(6) People diagnosed by a doctor with depression
(7) People who have had allergic reactions (rash, redness, itching, edema, etc.) to this product or its ingredients
(8) People with jaw joint disorders
2. Breastfeeding women should not use this product or avoid breastfeeding if using it
(Nicotine passes into breast milk and may increase the infant’s heart rate.)
3. Do not do the following while using or immediately after using this product:
(1) Smoking
(2) Using nicotine patch products
4. Do not use for more than 6 months
■Consult
1. Consult a doctor, dentist, pharmacist, or registered seller before use if you fall under the following:
(1) Receiving treatment from a doctor or dentist
(2) Using other medications
(May affect the action of other drugs.)
(3) Elderly or under 20 years old
(4) Have had allergic reactions to drugs, etc.
(5) Have the following symptoms:
Abdominal pain, chest pain, stomatitis, sore throat, throat swelling
(6) Have been diagnosed with:
Heart disease (myocardial infarction, angina, arrhythmia), cerebrovascular disorders (cerebral infarction, cerebral hemorrhage, etc.), Buerger’s disease (peripheral vascular disorder), hypertension, thyroid dysfunction, pheochromocytoma or paraganglioma, diabetes (using insulin preparations), pharyngitis, esophagitis, gastric/duodenal ulcer, liver disease, kidney disease (may worsen symptoms or affect the action of currently used drugs), epilepsy
2. If the following symptoms appear after use, they may be side effects; stop use immediately and consult a doctor, pharmacist, or registered seller with this document
[Affected area: Symptoms]
Mouth/throat: stomatitis, sore throat
Digestive system: nausea, vomiting, abdominal discomfort, heartburn, loss of appetite, diarrhea
Skin: rash, redness, itching
Nervous system: headache, dizziness, decreased thinking ability, drowsiness
Circulatory system: palpitations
Others: chest discomfort, chest irritation, facial flushing, facial edema, feeling unwell
3. The following symptoms may appear after use; if these symptoms persist or worsen, stop use and consult a doctor, dentist, pharmacist, or registered seller with this document
(1) Irritation in the mouth/throat, rough tongue, abnormal taste, increased saliva, gingivitis
(These symptoms may lessen if you chew slowly.)
(2) Jaw pain
(There may be other causes.)
(3) Hiccups, burping
4. If you accidentally use more than the prescribed dose or a child accidentally ingests it, the following symptoms may appear; in such cases, immediately consult a doctor, pharmacist, or registered seller with this document
Nausea, increased saliva, abdominal pain, diarrhea, sweating, headache, dizziness, hearing impairment, general weakness (possible acute nicotine poisoning)
5. If continuing use for more than 3 months, consult a doctor, pharmacist, or registered seller with this document
(Long-term or excessive use may transfer nicotine dependence to this product.)

●Precautions for Storage and Handling
1. Store in a cool place with little humidity, away from direct sunlight (storing in a high-temperature place may cause the gum to stick to the sheet and be difficult to remove).
2. Although the packaging is designed so that children cannot easily open it, keep it out of reach of children.
3. Do not transfer to other containers (may cause misuse or quality changes).
4. Do not use products past the expiration date.
5. Wrap chewed gum in paper or similar and dispose of it out of reach of children.