Nicorette 2 mg - to quit smoking 30 mint chewable gums

Product Description

Mint Chewable Gums

Active ingredients

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

Excipients

NICORETTE medicated chewing gum 2 mg gum contains: anhydrous sodium carbonate, sodium bicarbonate, chewing gum base, sorbitol powder, sorbitol 70% solution, mint and fruit flavours, glycerin 85% solution. 4 mg gum contains: anhydrous sodium carbonate, chewing gum base, sorbitol powder, sorbitol 70% solution, mint and fruit flavours, glycerin 85% solution, quinoline yellow (E 104). NICORETTE medicated chewing gum mint flavour 2 mg gum contains: anhydrous sodium carbonate, sodium bicarbonate, chewing gum base, xylitol, mint essence, levomenthol, magnesium oxide. One 4 mg gummy contains: anhydrous sodium carbonate, chewing gum base, xylitol, peppermint essence, levomenthol, magnesium oxide, quinoline yellow (E 104). NICORETTE Fresh Mint Flavored Medicated Chewing Gum: One 2 mg gummy contains: Chewing gum base, xylitol, peppermint essence, sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, magnesium oxide, acacia, titanium dioxide, carnauba wax. One 4 mg gummy contains: Chewing gum base, xylitol, peppermint essence, sodium carbonate, acesulfame potassium, levomenthol, magnesium oxide, acacia, titanium dioxide, carnauba wax, quinoline yellow (E 104). NICORETTE Medicated Chewing Gum, Tutti Frutti Flavour: One 2 mg gummy contains: Chewing gum base, xylitol, Tutti Frutti essence, sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, hypromellose, sucralose polysorbate 80, magnesium oxide, acacia, titanium dioxide, carnauba wax. One 4 mg gummy contains: Chewing gum base, xylitol, Tutti Frutti essence, sodium carbonate, acesulfame potassium, levomenthol, hypromellose, sucralose polysorbate 80, magnesium oxide, acacia, titanium dioxide, carnauba wax, quinoline yellow (E 104). NICORETTE Medicated Chewing Gum Strong Mint Flavor: One 2 mg gummy contains: Chewing 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: Chewing 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, ice mint.

Therapeutic indications

Treatment for 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 aggravated angina pectoris; Prinzmetal's angina; severe cardiac arrhythmia; Acute stroke.

Dosage

Children and adolescents: NICORETTE chewing gum should not be administered to persons under 18 years of age without medical advice. Adults and the elderly: The dosage of NICORETTE depends on the number of cigarettes normally consumed by the individual smoker. It is advisable to start with the 2 mg preparation and, as needed, identify the optimal dosage and the number of gums to chew throughout the day. If 15 2 mg gums per day are not sufficient, as for example in heavy smokers (more than 20 cigarettes per day), it is preferable to use NICORETTE 4 mg chewable gums, or two 2 mg gums at the same time. Chew one gum whenever you feel the urge to smoke. It is important to CHEW VERY SLOWLY FOR AT LEAST 30 MINUTES to achieve the release of the nicotine. Chewing too quickly causes nicotine to be absorbed too quickly: to avoid this, it is recommended to stop chewing occasionally. Do not use more than 15 4 mg gums per day. The recommended duration of treatment is 3 months. After this period, the daily dose should be gradually reduced. Once this has decreased to 1-2 gums, it is recommended to try to completely stop using NICORETTE. However, it is advisable to keep a few gums on hand in case the cravings suddenly return. NICORETTE chewing gum is also easy to handle for diabetics because it contains no sucrose or glucose. It is not recommended to continue treatment beyond 12 months. Caution: Do not exceed the recommended dose. Use NICORETTE chewable gum as directed above when you feel the cravings, in order to maintain complete abstinence from smoking. The number of gums used must be sufficient to cover the nicotine requirement. For most smokers, 10 2 mg gummies per day are usually sufficient.

Warnings and Precautions

The cardiovascular effects of nicotine may be risky in patients with severe cardiovascular disease (peripheral occlusive arterial disease, cerebrovascular disease, unstable angina pectoris, and heart failure), vasospasms, uncontrolled hypertension, severe hepatic and/or renal insufficiency, and 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, like cigarettes, cigars, and tobacco, should be kept out of reach of children. Smokers with dentures may experience difficulty chewing NICORETTE gum; however, the special formulation of the chewing gum minimizes this inconvenience. Smoking and concomitant use of nicotine replacement therapy (NRT). When using nicotine replacement therapy products to reduce smoking, nicotine from cigarettes is also present in the body. It is unclear whether the nicotine from cigarettes influences the elimination of nicotine provided by nicotine replacement therapy products, or vice versa. Although it has been reported that nicotine is eliminated more rapidly in smokers than in nonsmokers, suggesting that nicotine itself promotes its own elimination, a more in-depth study has shown that the opposite is also true. Another study found that cotinine, the main metabolite of nicotine produced by smoking, did not increase or decrease nicotine elimination. In a more direct test conducted on the same subjects, the elimination of intravenous nicotine 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 on a low-sodium diet. The mint-free chewing gum contains sorbitol: use with caution in cases of hereditary fructose intolerance; it may cause stomach problems and diarrhea.

Interactions

Smoking is associated with an increase in CYP1A2 enzyme activity. After smoking cessation, a reduction in the clearance of substrates of this enzyme may occur. This may lead to an increase in plasma levels of some potentially clinically important drugs with a narrow therapeutic index, such as theophylline, tacrine, and clozapine. Smoking cessation may also increase the concentration of other drugs partially metabolized by the CYP1A2 enzyme, such as imipramine, olanzapine, clomipramine, and fluvoxamine, although data are limited and the possible clinical significance is unknown. Limited data also indicate that smoking may induce the metabolism of flecainide and pentazocine.

Undesirable effects

The most frequently reported undesirable effects in clinical trials are similar to those that may occur when smoking and may be caused by using more NICORETTE than the usual amount of cigarettes. These effects may include: cough, headache, mouth and throat irritation, nasal congestion, ulcerative ulcers, sore throat, anxiety, depression, malaise, vomiting, dry mouth, heartburn, joint pain, diarrhea, bloating, allergies, shortness of breath, thirst, and hiccups. Some symptoms, such as dizziness, headache, and insomnia, may be related to withdrawal symptoms associated with quitting smoking and may also occur with insufficient use of NICORETTE.

Pregnancy and breastfeeding

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