“Active Ingredients
NICORETTE 4 mg Medicated Chewing Gum One gum contains: Active ingredient: 20 mg nicotine resin complex containing 20% nicotine, equivalent to 4 mg nicotine.
Excipients
NICORETTE Medicated chewing gum with mint flavour. One 4 mg gum contains: anhydrous sodium carbonate, basic chewing gum, xylitol, mint essence, levomenthol, magnesium oxide, quinoline yellow (E 104).
Therapeutic indications: Treatment of smoking cessation.
Contraindications: Nicorette should not be administered to non-smokers or patients with known hypersensitivity to nicotine. In case of recent myocardial infarction, unstable or worsening angina, Prinzmetal’s angina, severe cardiac arrhythmia, acute stroke.
Dosage: Children and adolescents. NICORETTE chewing gum should not be given to persons under 18 years of age without consulting a doctor.
Adults and the elderly. The dosage of NICORETTE depends on the number of cigarettes usually smoked by the smoker. It is advisable to start with the drug at a dose of 2 mg, determining, if necessary, the optimal dosage and the number of chewing gums to be chewed during the day. If 15 chewing gums of 2 mg per day are not enough, for example, in heavy smokers (more than 20 cigarettes per day), it is preferable to use NICORETTE 4 mg chewing gum or two chewing gums of 2 mg at the same time. Chew the gum every time you feel the urge to smoke. It is important to chew very slowly, for at least 30 minutes, to achieve the release of nicotine. Chewing too quickly leads to too rapid absorption of nicotine: to avoid this inconvenience, it is advisable to interrupt chewing from time to time. Do not take more than 15 gummies of 4 mg per day. The recommended duration of treatment is 3 months. After this period, the daily dose should be gradually reduced. As soon as this number of gums drops to 1-2, it is recommended to try to stop using NICORETTE completely. However, it is a good idea to have a spare gum on hand in case the desire to smoke suddenly returns. NICORETTE chewing gum is also convenient for diabetics, as it does not contain sucrose and glucose. It is not recommended to continue treatment for more than 12 months. Warning: do not exceed the recommended doses. Use NICORETTE gum as directed above whenever you feel the urge to smoke, in order to abstain completely from smoking. The number of gums used should be sufficient to cover the nicotine requirement. For most smokers, 10 gums of 2 mg per day are usually sufficient.
Warnings and Precautions
The cardiovascular effects of nicotine may be dangerous in patients with severe cardiovascular disease (occlusive peripheral arterial disease, cerebrovascular disease, unstable angina and heart failure), vasospasm, uncontrolled hypertension, severe liver and/or kidney failure, active duodenal and gastric ulcer. NICORETTE should be used with caution and under close medical supervision in patients with diabetes mellitus, hyperthyroidism or pheochromocytoma, since nicotine causes the release of catecholamines from the adrenal glands. However, the use of NICORETTE is less risky than smoking. The product should be kept out of the reach of children, like cigarettes, cigars and tobacco. Smokers with dentures may have difficulty chewing NICORETTE gum: however, the special composition of the gum minimizes this inconvenience. Smoking and concomitant use of nicotine replacement therapy (NRT) When you use nicotine replacement therapy products to reduce smoking, nicotine released from cigarettes is also present in your body. It is unclear whether the nicotine released by cigarettes affects the elimination of nicotine provided by the NRT products or vice versa. Although nicotine has been reported to be cleared more quickly in smokers than in non-smokers, suggesting that nicotine itself promotes its own clearance, more in-depth research has shown that the opposite is also true. Another study found that cotinine, the main metabolite of nicotine produced during smoking, neither increases nor decreases nicotine clearance. In a more direct test in the same subjects, clearance of intravenous nicotine was 36% slower during a short period of smoking compared with a short period of abstinence. This product contains sodium salts: use with caution in individuals on a low-sodium diet. Non-mint gum contains sorbitol: use with caution in cases of hereditary fructose intolerance, as it may cause stomach problems and diarrhea.”
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