Nicorette Gums 4mg Nicotine Mint 105 Chewable Gummies

NICORETTE 2 mg medicated chewing gum One gum contains: active ingredient: 10 mg of nicotine resin complex containing 20% nicotine, corresponding to 2 mg of nicotine. NICORETTE 4 mg medicated chewing gum One gum contains: active ingredient: 20 mg of nicotine resin complex containing 20% nicotine, corresponding to 4 mg of nicotine. For excipients see par. 6.1

NICORETTE medicated chewing gum A 2 mg gum contains: anhydrous sodium carbonate, sodium bicarbonate, chewing gum base, sorbitol powder, 70% sorbitol solution, mint and fruit flavors, 85% glycerin solution. A 4 mg gum contains: anhydrous sodium carbonate, chewing gum base, sorbitol powder, 70% sorbitol solution, mint and fruit flavors, 85% glycerin solution, quinoline yellow (E 104). NICORETTE Mint Flavor Medicated Chewing Gum A 2 mg gum contains: anhydrous sodium carbonate, sodium bicarbonate, chewing gum base, xylitol, mint essence, levomenthol, magnesium oxide. A 4 mg gum contains: anhydrous sodium carbonate, chewing gum base, xylitol, mint essence, levomenthol, magnesium oxide, quinoline yellow (E 104). NICORETTE medicated chewing gum fresh mint flavor: A 2 mg gum contains: Chewing gum base, xylitol, mint essence, sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, magnesium oxide, acacia, titanium dioxide, carnauba wax . A 4 mg gum contains: Chewing gum base, xylitol, mint essence, sodium carbonate, acesulfame potassium, levomentol, magnesium oxide, acacia, titanium dioxide, carnauba wax, quinoline yellow (E 104). NICORETTE chewing gum medicated taste tuttifrutti: A 2 mg gum contains: chewing gum base, xylitol, tuttifrutti essence, sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, hypromellose, sucralose polysorbate 80, magnesium oxide, acacia, titanium dioxide, carnauba wax. A 4 mg gum contains: Chewing gum base, xylitol, all fruit essence, sodium carbonate, acesulfame potassium, levomentol, hypromellose, sucralose polysorbate 80, magnesium oxide, acacia, titanium dioxide, carnauba wax, quinoline yellow (E 104 ). NICORETTE strong mint flavored medicated chewing gum: A 2 mg gum contains: Chewing gum base, xylitol, peppermint oil, acesulfame potassium, sodium carbonate, sodium bicarbonate, levomenthol, magnesium oxide, pregelatinised starch, titanium dioxide, carnauba, hypromellose, sucralose, polysorbate 80, glacial mint. A 4 mg gum contains: Chewing gum base, xylitol, peppermint oil, acesulfame potassium, sodium carbonate, levomentol, magnesium oxide, pregelatinised starch, titanium dioxide, carnauba wax, quinoline yellow (E 104), hypromellose, sucralose , polysorbate 80, glacial mint.

Treatment for smoking cessation.

Nicorette should not be used in non-smokers or in patients with known hypersensitivity to nicotine. In case of recent myocardial infarction; unstable or aggravated angina pectoris; Prinzmetal's angina; severe cardiac arrhythmia; acute stroke.

Children and adolescents NICORETTE chewing gum should not be given to people under the age of 18 without medical advice. Adults and the elderly The dosage of NICORETTE depends on the quantity of cigarettes normally consumed by the individual smoker. It is advisable to start with the 2 mg preparation by identifying, as needed, the optimal dosage, the number of chewing gums during the day. If 15 2 mg gums per day are not sufficient, as for example in heavy smokers (more than 20 cigarettes a day) it is preferable to use NICORETTE 4 mg chewable gum, or two 2 mg gums at the same time. Chew gum whenever you feel the need to smoke. It is important to CHEW VERY SLOWLY FOR AT LEAST 30 MINUTES to get the nicotine released. Chewing too fast causes the absorption of nicotine in too short a time: to avoid this inconvenience it is advisable to stop chewing from time to time. Do not use more than 15 4mg gums per day. The recommended duration of treatment is 3 months. After this period, the daily dose should be gradually reduced. When this has dropped to 1- 2 tires, it is recommended that you try to stop using NICORETTE completely. However, it is advisable to have some spare chewing gum on hand in case of a sudden return of the desire to smoke. NICORETTE chewing gum is easy to handle even for diabetics because it does not contain sucrose or glucose. It is not advisable to extend the treatment beyond 12 months. Warning: Do Not Exceed The Recommended Doses. Use NICORETTE chewable gum as indicated above, when you feel the desire to smoke, in order to maintain complete abstention from smoking. The number of gums used must be sufficient to cover the nicotine requirement. For most smokers, 10 x 2 mg gums per day are usually sufficient.

The cardiovascular effects of nicotine may be risky in patients with severe cardiovascular disease (peripheral arterial occlusive disease, cerebrovascular disease, unstable angina pectoris, and heart failure), vasospasm, uncontrolled hypertension, severe hepatic and / or renal insufficiency, active duodenal and gastric ulcers . NICORETTE should be used with caution and under close medical supervision by 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 must be kept out of the reach of children, similarly to cigarettes, cigars and tobacco Smokers with dental prostheses may have difficulty chewing NICORETTE gum: the special formulation of the chewing gum, however, minimizes this inconvenience. Smoking and concomitant use of nicotine replacement therapy (NRT) When nicotine replacement therapy products are used to reduce smoking, nicotine released from cigarettes is also present in the body. It is unclear whether nicotine released from cigarettes affects the elimination of nicotine provided by replacement therapy products or vice versa. Although nicotine has been reported to be eliminated more rapidly by smokers than by non-smokers, suggesting that nicotine itself promotes their own elimination, a more thorough study has shown that the reverse is also true. Another study found that cotinine, the major metabolite of nicotine produced by smoking, did not increase or decrease the elimination of nicotine. In a more direct test, conducted on the same subjects, the elimination of nicotine administered intravenously was 36% slower during a short period of smoking compared to a short period of abstinence. The product contains sodium salts: use with caution in subjects following low-sodium diets. Chewing gums without mint contain sorbitol: use with caution in cases of hereditary fructose intolerance; it can cause stomach problems and diarrhea.

Smoking is associated with an increase in CYP1A2 enzyme activity. After quitting smoking, a reduction in the clearance of substrates of this enzyme may occur. This may lead to increased plasma levels of some medicinal products of potential clinical importance for those drugs with a narrow therapeutic index such as theophylline, tacrine and clozapine. Smoking cessation may also increase the concentration of other drugs partially metabolised by the CYP1A2 enzyme, such as imipramine, olanzapine, clomipramine and fluvoxamine, although data are scarce and the possible clinical significance unknown. Limited data also indicate that smoking can induce the metabolism of flecainide and pentazocine.

The most frequently reported side effects in clinical trials are similar to those that may occur when smoking and may be caused by excessive use of NICORETTE compared to the usual amount of cigarettes. These effects may include: cough, headache, mouth and throat irritation, congestion, nasal, ulcerative sores, sore throat, anxiety, depression, malaise, vomiting, dry mouth, heartburn, joint pain, diarrhea, bloating , allergy, shortness of breath, feeling thirsty and hiccups Some symptoms such as dizziness, headache and insomnia may be related to the withdrawal symptoms associated with stopping smoking and may also occur in the case of insufficient use of NICORETTE.

Pregnancy Only if the pregnant woman continues to smoke, can the use of NICORETTE be justified, the use of which may involve potential risks. Nicotine reaches the fetus and affects its cardiorespiratory system. The effect is dose dependent. Therefore, pregnant women smokers are advised to stop smoking completely without undertaking nicotine replacement therapy. The risk of continuing to smoke could cause more harm to the fetus than that caused by the use of a nicotine replacement therapy according to a controlled smoking cessation program. Breastfeeding Nicotine passes freely into breast milk in quantities which may have harmful effects on the infant. This also happens with the use of drugs containing nicotine, at the recommended therapeutic doses.