“Active ingredients
NICORETTE 2 mg is a medicinal chewing gum. One chewing gum contains: active ingredient: 10 mg of nicotine resin complex containing 20% nicotine, which corresponds to 2 mg of nicotine.
Excipients
The composition of the 2 mg chewing gum includes: anhydrous sodium carbonate, sodium bicarbonate, chewing gum base, sorbitol powder, 70% sorbitol solution, mint and fruit flavors, 85% glycerol solution. The 4 mg gum contains: anhydrous sodium carbonate, basic chewing gum, sorbitol powder, 70% sorbitol solution, mint and fruit flavors, 85% glycerol solution, 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 for 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 chewing candies 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 completely stop using NICORETTE. However, it is a good idea to have a spare gum on hand in case the urge to smoke suddenly returns. NICORETTE gum is also convenient for diabetics, as it does not contain sucrose or glucose. It is not recommended to continue treatment for more than 12 months. Warning: Do not exceed the recommended dose. Use NICORETTE gum as 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. Most smokers usually need 10 gums of 2 mg per day.
Warnings and precautions
The cardiovascular effects of nicotine may be dangerous in patients with severe cardiovascular disease (peripheral arterial occlusive disease, cerebrovascular disease, unstable angina and heart failure), vasospasm, uncontrolled hypertension, severe hepatic and/or renal 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, as well as cigarettes, cigars and tobacco. Smokers with dentures may have difficulty chewing NICORETTE gum, but the special formulation 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 NRT products, or vice versa. Although it has been reported that nicotine is eliminated more quickly in smokers than in non-smokers, suggesting that nicotine itself promotes its own elimination, a more in-depth study has shown that the opposite is also true. Another study has shown that cotinine, the main metabolite of nicotine produced during smoking, does not increase or decrease nicotine elimination. In a more direct test on the same subjects, the clearance of intravenous nicotine was 36% slower during a short period of smoking compared to a short period of abstinence. Contains sodium salts: use with caution in individuals on a low-sodium diet. Non-mint gum contains sorbitol.”
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