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Nicorette 2 mg original to quit smoking 30 chewing gums
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Medicines authorized by the Ministry of Health
Chewing Gum
Active ingredients
NICORETTE 2 mg medicated chewing gum. One gummy contains: active ingredient: 10 mg of nicotine resin complex containing 20% nicotine, corresponding to 2 mg of nicotine.
Excipients
One 2 mg gummy contains: anhydrous sodium carbonate, sodium bicarbonate, chewing gum base, sorbitol powder, 70% sorbitol solution, mint and fruit flavors, 85% glycerin solution. One 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).
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, identifying, as needed, the optimal dosage and the number of gums to chew throughout the day. If 15 gums of 2 mg per day are not sufficient, as for heavy smokers (more than 20 cigarettes per day), it is preferable to use NICORETTE 4 mg chewable gums, or two gums of 2 mg 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 the nicotine to be absorbed too quickly: to avoid this inconvenience, it is advisable to stop chewing occasionally. Do not use more than 15 gums of 4 mg per day. The recommended duration of treatment is 3 months. After this period, the daily dose should be gradually reduced. Once this has dropped to 1-2 gums, it is advisable 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 use for diabetics because it contains no sucrose or glucose. It is not advisable to continue treatment beyond 12 months. Caution: Do not exceed the recommended dose. Use NICORETTE chewing 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 from 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 showed 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 intravenously administered 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 quitting smoking, a reduction in the clearance of substrates of this enzyme may occur. This may lead to: Smoking cessation may lead to increased 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, it is recommended to monitor the baby's development. 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 amounts that can have harmful effects on the infant. This also occurs with the use of nicotine-containing medications, at the recommended therapeutic doses.
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This product has been on sale since 25/09/2017
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