NICORETTE * 30 TIRES MAST 2MG MEN

NICORETTE * 30 TIRES MAST 2MG MEN

Therapeutic indications

Treatment for smoking cessation.

Dosage and method of use

Dosage: The dosage of NICORETTE depends on the quantity of cigarettes normally consumed by the individual smoker.Adults and the elderly: It is advisable to start with the 2 mg preparation by identifying, as necessary, the optimal dosage, that is, the number of chewing gums during the day. The number of gums used must be sufficient to cover the nicotine requirement. Chew gum whenever you feel the need to smoke. In most smokers, 10 x 2 mg gums per day are usually sufficient. 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. 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. 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. For the use of NICORETTE gum in diabetic subjects see section 4.4. It is not advisable to extend the treatment beyond 12 months. Pediatric population: The safety and efficacy in children and adolescents less than 18 years of age has not yet been established.Method of administration: It's importantCHEW VERY SLOWLY FOR AT LEAST 30 MINUTESto obtain the release of nicotine. 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.

Contraindications

Hypersensitivity to nicotine or to any of the excipients listed in section 6.1 NICORETTE should not be administered in the following cases: • non-smokers; • recent myocardial infarction; • unstable or aggravated angina pectoris; • Prinzmetal's angina; • severe cardiac arrhythmia; • acute stroke; • pregnancy and lactation (see section 4.6); • children and adolescents under 18 years of age.

Side effects

Nicotine withdrawal: Abrupt discontinuation of tobacco-containing products after a prolonged period of daily use causes a characteristic withdrawal syndrome characterized by the following manifestations: dysphoria or depressed mood; insomnia; irritability, frustration, anger; anxiety; difficulty concentrating, restless or impatient; bradycardia; increased appetite or body weight, dizziness and headache. The intense craving for nicotine, which is recognized as a relevant clinical symptom, is also an important element in nicotine withdrawal. Most of the undesirable effects experienced by subjects occur during the first phase of treatment and are mainly dose dependent. Mouth and throat irritation may occur, however most people adapt with continued use.Adverse reactions reported in clinical studies: The safety of nicotine from clinical trials is based on data from a meta-analysis of randomized clinical trials for the treatment of smoking cessation. Table 1 lists adverse reactions reported with a frequency ≥1%, identified from a meta-analysis of clinical trial data with oral nicotine formulations.

Gastrointestinal disorders	Abdominal pain, dry mouth, dyspepsia, flatulence, nauseato, salivary hypersecretion, stomatitis, vomitingto.
General disorders and administration site conditions	Burning on application, fatigueto.
Disorders of the immune system	Hypersensitivityto
Nervous system disorders	Headacheto, dysgeusia, paraesthesiato.
Respiratory, thoracic and mediastinal disorders	Cough, hiccups, throat irritation.

^to

Systemic effect. Other effects may include: mouth irritation, ulcerative canker sores, anxiety, depression, vomiting, joint pain, heartburn, bloating, feeling thirsty.Adverse reactions reported from post-marketing experience. Undesirable effects collected from post-marketing experience are reported according to frequency categories using the following convention: very common (≥ 1/10); common (≥1 / 100 and ≥ 1/10,000 e

Cardiac pathologies Uncommon Palpitations *, tachycardia * Eye disorders Not known Blurred vision, increased lacrimation Gastrointestinal disorders Common Diarrhea Uncommon Eructation, glossitis, vesicles of the oral mucosa, oral paraesthesia Rare Dysphagia, oral hypoesthesia, retching Not known Dry throat, gastrointestinal upset *, lip pain General disorders and administration site conditions Uncommon Asthenia *, chest discomfort *, chest pain *, malaise *. Disorders of the immune system Not known Anaphylactic reaction * Musculoskeletal and connective tissue disorders Uncommon Pain in the jaw Not known Muscle tension Psychiatric disorders Uncommon Abnormal dreams * Respiratory, thoracic and mediastinal disorders Uncommon Bronchospasm, dysphonia, dyspnoea *, nasal congestion, oropharyngeal pain, sneezing, throat tightness Skin and subcutaneous tissue disorders Uncommon Hyperhidrosis *, pruritus *, rash *, urticaria * Not known Angioedema *, erythema * Vascular pathologies Uncommon Redness *, hypertension *

* Systemic effects. Some symptoms, such as dizziness, headache, insomnia, dysphoria or depressed mood, irritability, frustration or anger, anxiety, difficulty concentrating, restlessness or impatience, bradycardia, increased appetite or body weight may be related to withdrawal symptoms associated with smoking cessation. An increased incidence of aphthous ulcer may occur following smoking cessation. The cause is not clear. Allergic reactions (including symptoms of anaphylaxis) rarely occur during the use of NICORETTE.Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at “www.agenziafarmaco.gov.it/it/responsabili”.

Special warnings

Nicotine administration should be temporarily interrupted if any symptoms of overdose occur (see section 4.9). If symptoms of nicotine overdose persist, nicotine intake should be decreased by both frequency of administration and dose reduction. It is important that therapy is supported by other activities to facilitate smoking cessation. A risk-benefit assessment by a competent physician is necessary for patients with the following conditions: • severe cardiovascular diseases (eg peripheral arterial occlusive diseases, cerebrovascular diseases, heart failure), vasospasms and uncontrolled hypertension, since the effects cardiovascular nicotine can be risky. Such patients should be encouraged to quit smoking with non-drug interventions (such as counseling); if this is not enough, medicated chewing gum therapy may be considered. As safety data in this patient group are limited, treatment should only be initiated with caution; • moderate and severe hepatic insufficiency and / or severe renal insufficiency. Use with caution in such patients as clearance of nicotine or its metabolites may be reduced with a potential for increased adverse effects; • esophagitis and / or gastric or peptic ulcers. Use with caution in such patients as nicotine can worsen the symptoms of these conditions; • diabetes mellitus. Such patients should be advised to monitor their blood sugar levels more frequently than usual because, when smoking is stopped and nicotine replacement therapy (NRT) is started, nicotine-induced catecholamine release is reduced and this can affect carbohydrate metabolism; • uncontrolled hyperthyroidism or pheochromocytoma, as nicotine causes the release of catecholamines from the adrenal glands. The use of NICORETTE is less risky than smoking. Smokers with dentures may have difficulty chewing NICORETTE gum, chewing gum can stick to the dentures and in rare cases damage them. Stopping smoking, with or without nicotine substitutes, may alter the pharmacokinetics of some concomitantly administered drugs (see section 4.5). A persistence of nicotine addiction may occur.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.Important information about some of the ingredients:NICORETTE medicated chewing gum, contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.

Pregnancy and breastfeeding

Smoking during pregnancy is associated with serious health risks for the woman, the fetus and the baby. Smoking can cause fetal harm such as intrauterine growth retardation, premature birth or neonatal death. It is therefore desirable to stop as soon as possible. Pregnancy: Pregnant women should only use NICORETTE under medical supervision. Only if the pregnant woman continues to smoke, can the use of NICORETTE be justified, the use of which may involve potential risks. Specific effects of NICORETTE on fetal development are unknown. Nicotine reaches the fetus and affects its cardiorespiratory system. The effect is dose-dependent. Therefore, pregnant women smokers are advised to quit smoking completely without undertaking nicotine replacement therapy. The risk of continuing to smoke may cause more harm to the fetus than that caused by the use of nicotine replacement therapy according to a controlled smoking cessation program. Cases of spontaneous abortion have been reported during therapy; as for smoking, it cannot be excluded that nicotine may contribute to this occurrence. Nicorette is not recommended during labor and delivery. The effects of nicotine on the mother or fetus during labor are unknown. Feeding time: Nicotine passes freely into breast milk in quantities that can have harmful effects on the infant. This also happens with the use of drugs containing nicotine, at the recommended therapeutic doses. The effect of the medicine in nursing infants has not been investigated. The milk-plasma ratio is of the order of 2.9. A newborn eliminates nicotine by means of the first hepatic pass however the efficiency of the removal is lower at birth. It is assumed that with the correct use of NICORETTE the nicotine concentrations in breast milk are lower than those obtained with cigarette smoking, as with replacement therapy the nicotine concentrations in maternal plasma are generally reduced. Medicated chewing gums should therefore be avoided during breastfeeding. In case you are unable to stop smoking, the use of NICORETTE in women who are breastfeeding should only be started after consulting your doctor.

Expiration and retention

Store below 25 ° C.

Interactions with other drugs

Clinically relevant interactions between nicotine replacement therapy and other medicinal products have not been definitively established. However, nicotine has the potential to increase the haemodynamic effects of adenosine, such as increased blood pressure, heart rate and also increased pain response (such as chest pain, angina pectoris) caused by adenosine administration. Smoking (but not nicotine) 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 phenacetin, caffeine, theophylline, tacrine, clozapine and ropinirole. Smoking cessation can increase plasma levels of: • acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol, theophylline, due to the inhibition of liver enzymes; • insulin, due to increased subcutaneous absorption of insulin; • adrenergic antagonists (prazosin, labetalol) and adrenergic agonists (isoprenaline, phenylephrine), due to the decrease in the circulation of catecholamines caused by smoking cessation. • olanzapine, clomipramine and fluvoxamine as they are partially metabolised by the CYP1A2 enzyme, although data are scarce and possible clinical significance unknown. In such cases, a dose reduction may be required upon cessation of smoking. Furthermore, stopping smoking can decrease: • the absorption of glutethymide; • phase I metabolism of propoxyphene. Both smoking and nicotine can increase circulating levels of cortisol and catecholamines. Therapies with agonists or adrenergic blockers may need to be fine-tuned in relation to the stages of nicotine therapy or the amount of cigarettes smoked. Therefore in case of concomitant therapies it is necessary to consult the doctor. Limited data also indicate that smoking can induce the metabolism of flecainide and pentazocine.

Overdose

If the patient is an occasional smoker or smokes a few cigarettes a day, or chews NICORETTE gums at the same time as taking other forms of nicotine (inhaler, patches,) an overdose may occur. Symptoms of overdose come in the form of nicotine poisoning and include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, sweating, headache, dizziness, impaired hearing, noticeable weakness. At high doses, these symptoms may be followed by hypotension, weak and irregular pulse, difficulty in breathing, prostration, circulatory collapse and generalized convulsions. Doses of nicotine tolerated by adult smokers during treatment can cause severe symptoms of poisoning in children and can be fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately. The acute minimal lethal oral dose of nicotine in humans is thought to be between 40 and 60 mg.Treatment of overdose:Nicotine intake should be stopped immediately and the patient treated symptomatically. If necessary, use artificial respiration with oxygen. If an excessive amount of nicotine is taken, activated charcoal reduces the gastrointestinal absorption of nicotine.

Active principles

NICORETTE 2 mg medicated chewing gumOne gum contains: • active ingredient: 10 mg of nicotine resin complex containing 20% nicotine, corresponding to 2 mg of nicotine; • excipient with known effect: sorbitol.NICORETTE 4 mg medicated chewing gumOne gum contains: • active ingredient: 20 mg of nicotinic resin complex containing 20% nicotine, corresponding to 4 mg of nicotine; • excipient with known effect: sorbitol.NICORETTE 2 mg medicated chewing gum strong mint flavorOne 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 with strong mint flavorOne gum contains: • active ingredient: 20 mg of nicotinic resin complex containing 20% nicotine, corresponding to 4 mg of nicotine. For the full list of excipients see section 6.1.

Excipients

NICORETTE 2 mg medicated chewing gum: One gum contains: anhydrous sodium carbonate, sodium bicarbonate, chewing gum base, sorbitol powder, 70% sorbitol solution, mint and fruit flavors, 85% glycerin solution.NICORETTE 4 mg medicated chewing gum: One gum contains: anhydrous sodium carbonate, chewing gum base, sorbitol powder, sorbitol 70% solution, mint and fruit flavors, glycerin 85% solution, quinoline yellow (E 104).NICORETTE 2 mg medicated chewing gum strong mint flavor: One gum contains: chewing gum base, xylitol, peppermint oil, acesulfame potassium, sodium carbonate, sodium bicarbonate, levomentol, magnesium oxide, pregelatinised starch, titanium dioxide, carnauba wax, hypromellose, sucralose, polysorbate 80, glacial mint .NICORETTE 4 mg medicated chewing gum strong mint flavor: One gum contains: chewing gum base, xylitol, peppermint oil, acesulfame potassium, sodium carbonate, levomenthol, magnesium oxide, pregelatinised starch, titanium dioxide, carnauba wax, quinoline yellow (E 104), hypromellose, sucralose, polysorbate 80, glacial mint.