“Active ingredients
NICORETTE 2 mg medicated chewing gum One gum contains: active ingredient: 10 mg nicotine gum complex containing 20% nicotine, equivalent to 2 mg nicotine. NICORETTE 4 mg medicated chewing gum One gum contains: active ingredient: 20 mg nicotine gum complex containing 20% nicotine, equivalent to 4 mg nicotine. For information on excipients, see section 6.1
Excipients
NICORETTE medicated chewing gum One gum 2 mg contains: anhydrous sodium carbonate, sodium bicarbonate, basic chewing gum, sorbitol powder, 70% sorbitol solution, mint and fruit flavours, 85% glycerol solution. 4 mg gum contains: anhydrous sodium carbonate, basic chewing gum, sorbitol powder, 70% sorbitol solution, mint and fruit flavours, 85% glycerol solution, quinoline yellow (E 104). NICORETTE medicated chewing gum with mint flavour One 2 mg chewing gum contains: anhydrous sodium carbonate, sodium bicarbonate, basic chewing gum, xylitol, mint essence, levomenthol, magnesium oxide. One 4 mg gum contains: anhydrous sodium carbonate, basic chewing gum, xylitol, mint essence, levomenthol, magnesium oxide, quinoline yellow (E 104). NICORETTE fresh mint flavoured medicated chewing gum: one 2 mg gum contains: chewing gum base, xylitol, mint essence, sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, magnesium oxide, gum arabic, titanium dioxide, carnauba wax. A 4 mg gum contains: chewing gum base, xylitol, mint essence, sodium carbonate, acesulfame potassium, levomenthol, magnesium oxide, acacia, titanium dioxide, carnauba wax, quinoline yellow (E 104). NICORETTE tuttifrutti flavoured medicated chewing gum: 2 mg of chewing gum contains: chewing gum base, xylitol, tuttifrutti essence, sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, hypromellose, polysorbate sucralose 80, magnesium oxide, gum arabic, titanium dioxide, carnauba wax. 4 mg of gum contains: chewing gum base, xylitol, tuttifrutti essence, sodium carbonate, acesulfame potassium, levomenthol, hypromellose, polysorbate sucralose 80, magnesium oxide, gum arabic, titanium dioxide, carnauba wax, quinoline yellow (E 104). NICORETTE Strong Mint Chewing Gum: One 2 mg gum contains: gum base, xylitol, peppermint oil, acesulfame potassium, sodium carbonate, sodium bicarbonate, levomenthol, magnesium oxide, pregelatinized starch, titanium dioxide, carnauba wax, hypromellose, sucralose, polysorbate 80, glacial mint. One 4 mg gum contains: gum base, xylitol, peppermint oil, acesulfame potassium, sodium carbonate, levomenthol, magnesium oxide, pregelatinized starch, titanium dioxide, carnauba wax, quinoline yellow (E 104), hypromellose, sucralose, polysorbate 80, glacial acid. mint.
Therapeutic indications: Smoking cessation treatment.
Contraindications
Nicorette should not be administered to non-smokers or patients with known hypersensitivity to nicotine. In case of recent myocardial infarction; unstable or aggravated 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 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 the treatment for more than 12 months. Warning: Do not exceed the recommended doses. Use NICORETTE gum as above whenever you feel the urge to smoke to completelyrefrain from smoking. The amount of chewing gum used should be sufficient to cover the need for nicotine. Most smokers usually need 10 chewing gums of 2 mg per day.”
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