NICORETTE INAL 20FL 1D

NICORETTE DEVELOPMENT

active ingredients

NICORETTE 10 mg solution for inhalation Each container contains § active ingredient: nicotine 10 mg. NICORETTE 15 mg solution for inhalation Each container contains § active ingredient: nicotine 15 mg. For the full list of excipients see paragraph 6.1.

Excellent

Levomentolo, porous filter.

Therapeutic indications

Treatment for disinfection from tobacco. It relieves withdrawal symptoms. It helps reduce smoking dependence and consequently the number of smoked cigarettes.

Contraindications

Hypersensitivity to nicotine or any of the excipients listed in paragraph 6.1 NICORETTE should not be administered in the following cases: § recent myocardial infarction (within 3 months); § angina pectoris unstable or aggravated; § angina of Prinzmetal; § severe heart arrhythmia; § stroke acute; § children and adolescents with less than 18 years; § pregnancy and nursing (see paragraph 4.6); § non-smoking subjects.

Population

Population Adults and elderly The dose is ad libitum, that is to be defined on an individual basis, depending on the need that the patient has to reduce symptoms from a stinence associated with the suspension of smoking. . NICORETTE should be used when the patient feels the need to smoke a cigarette or when other withdrawal symptoms appear. NICORETTE 10 mg solution for inhalation To efficiently control the withdrawal symptoms associated with smoking interruption, from no less than 6 containers per day to no more than 12 containers per day. NICORETTE 15 mg solution for inhalation To efficiently control the withdrawal symptoms associated with smoking interruption, from no less than 3 containers per day to no more than 6 containers per day. NICORETTE should be used as a cigarette so as to mimic the gestures linked to the habit of smoking. Studies prove that different inhalation techniques give similar effects, deep inhalation (mode of cigarette smoker) or a shallow aspiration (mode of pipe smoker). The amount of nicotine that is free from an aspiration is lower than that coming from cigarette smoke. If the relief from the desire is not enough, increase the frequency and/or size of the mouthpieces. Each 10 mg cartridge replaces about 3-4 cigarettes. Each 15 mg cartridge replaces about 7-8 cigarettes. The number, frequency, inhalation time and technique vary individually. The amount of nicotine released from NICORETTE can be decreased in a cold environment. Therefore it should not be used below 15°C. The recommended duration of treatment is 3 months. After this period, the daily dose will be gradually reduced over the next 6-8 weeks. The medicine should not be used for more than 6 months. Pediatric population Safety and effectiveness in children and adolescents under 18 years of age has not yet been established. Method of administration Inhalation.

Conservation

Store at a temperature not exceeding 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. When you start treatment the patient must immediately stop smoking. It is important that therapy is supported by other activities to facilitate smoking suspension. Patients who continue to smoke despite the therapy with NICORETTE side effects due to higher nicotine concentrations than those taken with the drug alone (see paragraph 4.9). An assessment of the risk-benefit ratio by a competent physician for patients with the following conditions is required: • 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; • kidney and dialysis diseases. Carefully use in such smokers and hemodialysis patients as high levels of nicotine have been observed; • esophagitis and/or gastric or peptic ulcers. Use carefully in such patients since nicotine can worsen the symptoms of these conditions; • severe cardiovascular diseases (e.g. peripheral occlusive arteriopathies, cerebrovascular diseases, heart failure), vasospasm and uncontrolled hypertension or peripheral vascular diseases. Such patients should be encouraged to stop smoking with non-pharmacological interventions (such as counselling); if that is not enough, NICORETTE can be considered. As security data in this group of patients are limited, treatment should only be started with caution; • uncontrolled hyperthyroidism or feocromocytoma. Use with caution in such patients since nicotine causes the release of catecholamines; • 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. • chronic diseases of the throat and bronchospasm. Use with caution NICORETTE in such patients. The suspension of smoking, with or without nicotine substitutes, may alter the pharmacokinetics of certain drugs administered in conjunction (see paragraph 4.5). . Pediatric population If a child ingests, chews or aspires the nicotine cartridge (both used and unused) there is the risk of poisoning (see paragraph 4.9).

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 (but not nicotine) 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 that may have a potential clinical importance for those drugs having a strict therapeutic index such as phenacetin, caffeine, theophylline, tacrine, chlozapine and ropinirol. The cessation of smoking may increase the plasma levels of: § acetaminophene, caffeine, imipramine, oxazepam, pentazocin, propranolol, theophylline, due to the inhibition of liver enzymes; § insulin, by increased subcutaneous absorption of insulin; § antagonists adrenergic (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 fluvoxamina 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

NICORETTE can cause side effects similar to those associated with nicotine administered by other ways. 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 reported adverse reactions with a frequency ≥1%, identified by a metaanalysis of clinical studies data with oral formulations of nicotine, more frequently with active treatment than with placebo treatment

Gastrointestinal diseases	Abdominal pain, dry mouth, dispepsia, flatulence, nausea*, salivary hypersecretion, stomatitis, vomiting*.
Systemic pathologies and conditions for administration	Burning in application, fatigue*, aftous ulcer
Immune system disorders	Hypersensitivity*
Diseases of the nervous system	Cephalea*, disgeusia, hiccup, paresthesia*
Respiratory, chest and mediastinic pathologies	Cough, throat irritation, nasal congestion, sinusitis.

*Systemic effect Reactions reported in post-marketing experience The side effects collected by post-marketing experience are shown, 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 Diarrea 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* 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 effect Some symptoms, such as dizziness, headaches and insomnia, discomfort 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 appearing with smoking suspension. After the suspension of smoking there is an increase in ulcerative aphtheses. The causality is not clear. Allergic reactions (including anaphylaxis symptoms) rarely occur when using NICORETTE. There may be a permanent dependence on nicotine. Reporting of suspected 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 “www.agenziafarmaco.gov.it/it/responsabili”.

Overdose

If the patient has a very low nicotine-dependence or uses other forms of nicotine in conjunction with treatment, a nicotine overdose may occur. The maximum nicotine plasma concentrations obtained as a result of forced inhalation were included in the range found in smokers. Synonyms Overdose symptoms are those from acute poisoning by nicotine and include nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweat, headaches, dizziness, hearing disorders and marked weakness. At high doses, these symptoms can be followed by: hypotension, weak and irregular pulse, breathing difficulties, prostration, circulatory collapse and generalized convulsions at the terminal stage. 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. Treatment Suspend nicotine intake immediately and treat the patient according to the symptoms it manifests. If necessary to establish 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 control medico.Solo in case the pregnant woman continues to smoke, 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 affects its cardio-respiratory 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.

Breastfeeding

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. 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. NICORETTE should 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