NICORETTE 105GOMME MAST 4MG ME

NICORETTE MEDICAL MASTICAL GOMME

active ingredients

NICORETTE 2 mg chewing gums medicated A rubber contains: • active ingredient: 10 mg of nicotinic resin complex containing 20% nicotine, corresponding to 2 mg of nicotine; • excipients with known effects: sorbitol, sodium, ethanol. Peppermint and fruit (contain cynnamal, cynnamic alcohol, cytronellol, eugenol, geraaniol, isoeugenol, lemon, linalol) 11 mg/ chewing gum. NICORETTE 4 mg chewing gums medicated A rubber contains: • active ingredient: 20 mg of nicotinic resin complex containing 20% nicotine, corresponding to 4 mg of nicotine; • excipients with known effects: sorbitol, sodium, ethanol. Peppermint and fruit (contain cynnamal, cynnamic alcohol, cytronellol, eugenol, geraaniol, isoeugenol, lemon, linalol) 11 mg/ chewing gum. NICORETTE 2 mg chewing gums medicate taste strong mint A rubber contains: active ingredient: 10 mg of nicotinic resin complex containing 20% nicotine, corresponding to 2 mg of nicotine. NICORETTE 4 mg chewing gums medicate taste strong mint A rubber 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 paragraph 6.1.

Excellent

NICORETTE 2 mg chewing gums medicated: A rubber contains: sodium carbonate anidro, sodium bicarbonate, basic chewing gum, sorbitol powder, sorbitol 70% solution, mint and fruit aromas (contain traces of ethanol, cynnamal, cynnamic alcohol, citronellol, eugenol, geranium, isoeugenol, lemon, linalol), glycerine solution to 85%. NICORETTE 4 mg chewing gums medicated: A rubber contains: sodium carbonate anidro, base chewing gum, powder sorbitol, 70% solution sorbitol, mint and fruit aromas (contain traces of ethanol, cinnamal, cinnamic alcohol, citronellol, eugenol, geranium, isoeugenol, lemon, linalol), glycerine solution to 85%, chinoline yellow (E 104). NICORETTE 2 mg chewing gums medicate taste strong mint: A rubber contains: basic chewing gum, xylitol, peppermint oil, potassium acesulfame, sodium carbonate, sodium bicarbonate, levomentol, magnesium oxide, pregelatinized starch, titanium dioxide, carnauba wax, ipromellose, sucralose, polysorbed 80, glacial mint. NICORETTE 4 mg chewing gums medicate taste strong mint: A rubber contains: basic chewing gum, xylitol, peppermint oil, potassium acesulfame, sodium carbonate, levomentol, magnesium oxide, pregelatinized starch, titanium dioxide, carnauba wax, yellow chinoline (E 104), ipromellose, sucralose, polysorbed 80, glacial mint.

Therapeutic indications

Treatment for disinfection from tobacco.

Contraindications

Hypersensitivity to nicotine or any of the excipients listed in paragraph 6.1 NICORETTE should not be administered in the following cases: • non-smoker; • recent myocardial infarction; • angina pectoris unstable or aggravated; • Prinzmetal angina; • severe heart arrhythmia; • acute stroke; • pregnancy and nursing (see paragraph 4.6); • children and teenagers with under 18 years of age.

Population

Population The dosage NICORETTE depends on the amount of cigarettes normally consumed by the single smoker. Adults and elderly It is advisable to start with the 2 mg preparation by identifying, according to the optimal dosage, that is the number of chewing gums during the day. The number of tyres used must be sufficient to cover nicotine requirements. Chew a rubber whenever you feel the need to smoke. In most smokers are usually enough 10 2 mg tires per day. In case there is not enough 15 2 mg tyres per day, such as strong smokers (more than 20 cigarettes per day) it is preferable to use NICORETTE 4 mg chewable tires, or two 2 mg rubbers simultaneously. Do not use more than 15 gums from 4 mg per day. The recommended duration of treatment is 3 months. After this period the daily dose will be gradually reduced. When this will be dropped to 1- 2 tires, it is recommended to try to completely stop the use of NICORETTE. However, it is appropriate to keep some chewing gum available, in case of a sudden return of the desire to smoke. For use of NICORETTE tires in diabetic subjects see paragraph 4.4. It is not recommended to protract treatment over 12 months. Pediatric population Safety and effectiveness in children and adolescents under 18 years of age has not yet been established. Method of administration It is important LENTLY MASTICAL FOR ALMENO 30 MINUTE to obtain the release of nicotine. Too fast chewing determines the absorption of nicotine in too short times: to avoid this inconvenience it is recommended to stop chewing from time to time.

Conservation

Store at a temperature below 25°C.

Warnings

The administration of nicotine must be temporarily interrupted if any symptom of overdose occurs (see paragraph 4.9). If nicotine overdose symptoms persist, nicotine intake must be decreased both for the frequency of administration and for lowering the dosage. It is important that therapy is supported by other activities to facilitate smoking suspension. An assessment of the risk-benefit ratio by a competent physician for patients with the following conditions is required: • severe cardiovascular disease (e.g. peripheral occlusive arteriopathy, cerebrovascular disease, heart failure), vasospasm and uncontrolled hypertension, since cardiovascular effects of nicotine can be risky. Such patients should be encouraged to stop smoking with non-pharmacological interventions (such as advice); if this is not enough, therapy with chewing gums can be taken into account. As security data in this group of patients are limited, treatment should only be started with caution; • moderate and severe liver failure and/or severe kidney failure. Carefully use in such patients since nicotine clearance or metabolites can be reduced with a potential increase in adverse effects; • esophagitis and/or gastric or peptic ulcers. Use carefully in such patients since nicotine can worsen the symptoms of these conditions; • diabetes mellitus. Such patients should be advised to monitor blood sugar levels more frequently than usual since, when smoking is stopped and nicotine-based replacement therapy (NRT), nicotine-induced catecholamine release is reduced and this can affect carbohydrates metabolism; • uncontrolled hyperthyroidism or feochromocytoma, since nicotine causes the release of catecholamines from the adrenal glands. The use of NICORETTE is less risky than smoking. Smoking wearers of dental prostheses can encounter difficulties in chewing NICORETTE tires, chewing gum can stick to the teether and in rare cases damage it. The suspension of smoking, with or without nicotine substitutes, may alter the pharmacokinetics of certain drugs administered in conjunction (see paragraph 4.5). There may be a permanent dependence on nicotine. Concurrent use of nicotine-based replacement therapy (NRT) When using nicotine-based replacement therapy products to reduce smoking, nicotine released by cigarettes is also present in the body. It is unclear whether nicotine released by cigarettes affects the elimination of nicotine provided by substitute therapy products or vice versa. Although it has been reported that nicotine is eliminated more quickly by smokers and non-smokers, suggesting that the nicotine itself favours its elimination, a more detailed study has shown that it is true also the opposite. Another study highlighted that cotinina, the main 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 intravenous nicotine was slower than 36% during a short period of smoking than a short period of withdrawal. Important information about some excipients NICORETTE 2 mg chewing gums medicated contains 202.4 mg of sorbitol. NICORETTE 4 mg chewing gums medicated contains 197 mg of sorbitol. Patients with hereditary fructose intolerance should not take this medicine. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. NICORETTE chewing gums medicate contains aromas with cinnamal, cynnamic alcohol, citral, citronellol, eugenol, geranium, isoeugenol, lemon, linalol in every rubber. These substances can cause allergic reactions. NICORETTE chewing gums medicate contains 0.616 mg of ethanol in each rubber, equivalent to less than 0.0154 ml of beer or 0.00616 ml of wine. The amount of ethanol contained in this medicine comes from the aromas contained in it. This ethanol content is such that it does not produce significant effects. NICORETTE 2 mg chewing gums medicate taste strong mint contains 171 mg sodium (main component of the kitchen salt) for maximum daily dose. This is equivalent to 8,55% of the recommended maximum daily intake with an adult's diet. NICORETTE 4 mg chewing gums medicate taste strong mint contains 195.2 mg sodium (main component of the kitchen salt) for maximum daily dose. This is equivalent to 9,76% of the maximum daily intake recommended with the diet of an adult.

Interactions

No clinically relevant interactions have been definitively established between nicotine-based replacement therapy and other medicines. However nicotine can potentially increase the hemodynamic 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 is associated with an increase in the enzymatic activity of CYP1A2. After stopping smoking, a reduction of clearance of substrates of this enzyme may occur. This can lead to an increase in plasma levels of some medicines of potential clinical importance for those drugs having a strict therapeutic index such as phenacetin, caffeine, theophylline, tacrine, chlozapine and ropinirol. The cessation of smoking can increase the plasma levels of: • acetaminophen, caffeine, imipramine, oxazepam, pentazocin, propranolol, theophylline, due to the inhibition of liver enzymes; • insulin by increased subcutaneous absorption of insulin; • adrenergic antagonists (prazosin, labetalol) and adrenergic agonists (isoprenaline, phenylphrine), due to the decrease in the circulation of catecholamines caused by the suspension of smoking. • olanzapine, chlomipramine and fluvoxamine as partially metabolized by the CYP1A2 enzyme, although the data is poor and the possible unknown clinical meaning. In such cases a decrease in the dose to the suspension of smoking may be necessary. The suspension of smoking can also decrease: • the absorption of glutetimide • phase I metabolism of propoxyphene Both smoking and nicotine can increase the circulating levels of cortisol and cateculamine. It may be necessary to develop therapies with agonists or adrenergic blockers in relation to the stages of nicotine therapy or the amount of smoked cigarettes. Therefore in case of concomitant therapies it is necessary to consult the doctor. Limited data also indicates that smoking can induce the metabolism of flecainide and pentazocin.

Effects

Synthetic Astine The sudden interruption of the intake of tobacco products after a prolonged period of daily use, causes a characteristic withdrawal syndrome characterized by the following manifestations: discomfort or depressed mood; insomnia; irritability, frustration, anger; anxiety; difficulty of concentration, restlessness or impatience; bradycardia; increased appetite or body weight, dizziness and headaches. The intense desire for nicotine, which is recognized as a significant clinical symptom, is also an important element in abstinence from nicotine. Most of the side effects manifested by subjects occur during the first phase of treatment and are mainly dependent dose. The irritation of the mouth and throat may occur, however most subjects adapt with continued use. Adverse reactions reported in clinical studies The safety of nicotine from clinical trials is based on the data of a meta-analysis of randomized clinical trials for the treatment of disassufaction from smoking. Table 1 shows adverse reactions reported with a frequency ≥1%, identified by a meta-analysis of clinical studies data with oral nicotine formulations.

Gastrointestinal diseases	Abdominal pain, dry mouth, dyspepsia, flatulence, nauseaa, saliva hypersecretion, stomatitis, vomitinga.
Systemic pathologies and conditions for administration	Burning in place of application, fatiguea.
Immune system disorders	Hypersensitivitya
Diseases of the nervous system	Cefaa, dysgeusia, paresthesiaa.
Respiratory, chest and mediastinic pathologies	Tosses, hiccups, throat irritation.

^a Systemic effect Other effects may include: mouth irritation, ulcerative aphthes, anxiety, depression, vomiting, joint pain, heartburn, meteorism, feeling of thirst. Adverse reactions from post-marketing experience The side effects collected by post-marketing experience are reported according to the frequency categories using the following convention: very common (≥ 1/10); common (≥1/100 and Heart disease Not common Palpitations*, tachycardia* Pathologies of the eye Notable Offused vision, increased tearing Gastrointestinal diseases Town Diarrhea Not common Eruttation, glossitis, oral mucosa vesicles, oral paresthesia Rare Disphagia, oral hypoesthesia, vomiting Notable Dry throat, gastrointestinal disorder*, lip pain Systemic pathologies and conditions for administration Not common Astenia*, chest discomfort*, chest pain*, malaise*. Immune system pathologies Notable Anaphylactic reaction* Diseases of musculoskeletal system and connective tissue Not common Sink pain Notable Muscle tension Psychiatric disorders Not common Abnormal dreams* Respiratory, chest and mediastinic pathologies Not common Broncospasm, dysphony, dyspnea*, nasal congestion, oropharynx pain, sneezing, throat tension Pathologies of skin and subcutaneous tissue Not common Hyperhidrosis*, itching*, skin rash*, hives* Notable Angioedema, erythema Vascular diseases Not common Redness*, hypertension* *Systemic effects Some symptoms, such as dizziness, headache, insomnia, dysphora 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 suspension. Increased incidence of aftous ulcer may occur as a result of smoking suspension. The cause is unclear. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . .

Overdosing

If the patient is an occasional smoker or smokes a few cigarettes a day, or chew the tires of NICORETTE at the same time, the intake of other forms of nicotine (inhaler, patches) can occur overdose. Overdose symptoms occur in the form of nicotine poisoning and include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, sweating, headaches, dizziness, hearing disorders, obvious weakness. At high doses, these symptoms can be followed by hypotension, weak and irregular pulse, difficulty breathing, prostration, circulatory collapse and generalized seizures. Nicotine doses tolerated by adult smokers during treatment can cause severe symptoms of poisoning in children and can be fatal. A suspected nicotine poisoning in a child must be considered a medical emergency and treated immediately. It is believed that the oral acute dose of nicotine in humans is between 40 and 60 mg. Treatment of overdose: nicotine intake must be stopped immediately and the patient must be treated in a symptomatic way. If necessary to resort to artificial breathing with oxygen. If an excessive amount of nicotine is assumed, the activated carbon reduces nicotine gastrointestinal absorption.

Pregnant smoking is associated with serious health risks of women, fetus and child. Smoking can cause fetus damage such as intrauterine growth delay, premature birth or neonatal death. It is therefore desirable to stop as soon as possible.

Pregnancy

Pregnant women should use NICORETTE only under medical control. Only in case the pregnant woman continues to smoke, can the use of NICORETTE, the use of which may lead to potential risks. The harmful effects of cigarette smoke during pregnancy and fetus health have been clearly identified and include low birth weight, increased risk of miscarriage, increased neonatal mortality. Specific effects of NICORETTE on the development of the fetus are unknown. Nicotine comes to the fetus and influences its cardiorespiratory apparatus. The effect on circulation is dose-dependent. It is therefore recommended for smokers to try to stop smoking without the use of drugs. Cases of miscarriage were reported during therapy; as for smoking, it cannot be excluded that nicotine can contribute to the occurrence of this eventuality. Nicorette is not recommended during labor and childbirth. The effects of nicotine on the mother or fetus during labor are unknown. The risk of continuing smoking may damage the fetus greater than the one caused by the use of nicotine-based replacement therapy, according to a controlled program of disassuefation from smoking.

Food

The effect of the medicinal product in children who are breastfeeding has not been examined. Nicotine passes freely in breast milk; the milk-plasm ratio is of the order of 2.9. This also happens with the use of drugs containing nicotine, at the recommended therapeutic doses. A newborn eliminates nicotine by means of the first hepatic passage however removal efficiency is lower at birth. It is assumed that with the correct use of NICORETTE nicotine concentrations in breast milk are lower than those obtained with cigarette smoke, as with substitute therapy nicotine concentrations in maternal plasma are generally reduced. Medicated chewing gums must therefore be avoided during breastfeeding. In case you are unable to quit smoking, use of NICORETTE in women who are breastfeeding must be started only after consulting the doctor.

Source: Farmadati