NIQUITIN 60PASTL 4MG MENT FL

NIQUITIN 4 MG PASTIGLI

active ingredients

Each pastel contains: nicotine 4 mg (as nicotine resin). For the full list of excipients, see the paragraph 6.1. Excipient with known effects: Each pill contains 4 mg sodium

Excellent

Mannitol (E421), Sodium alginate (E401), Gomma xantana (E415), Potassium bicarbonate (E501), Calcium polycarbophil, Sodium carbonate anidro (E500), Potassium acesulfame (E950), Mint flavor powder, Sucralosio (E955), Magnesium stearate (E470b).

Therapeutic indications

NiQuitin is indicated in the treatment of tobacco addiction to reduce symptoms of nicotine withdrawal, including the desire to smoke, during an attempt to stop smoking (see section 5.1). The permanent suspension of tobacco consumption is the ultimate goal. NiQuitin must be used preferably in association with a behavioral support program.

Contraindications

• Hypersensitivity to nicotine or any of the excipients listed in paragraph 6.1 • children under the age of 12 • non-smoker.

Population

Posology: Smokers must strive to stop smoking completely during treatment with NiQuitin. The dosage of the pill to be taken depends on the smoking habits of the individual subjects. NiQuitin 4 mg is indicated for smokers of more than 20 cigarettes per day. A support behavioural therapy generally improves success rates. Adults (from 18 years on): Take a pill every time you feel a strong need to smoke. A sufficient quantity of tablets should be used every day, generally 8-12, up to a maximum of 15. Continue to use tablets up to 6 weeks to stop smoking habit, then gradually reduce its consumption. When daily consumption is 1-2 tablets, treatment must be suspended. As help to stay without smoking after treatment, you can take a pill in situations where you are strongly tempted to smoke. It is recommended for those who take pills for more than 9 months to request additional advice and help to the doctor or pharmacist. Pediatric population: NiQuitin can be used by teenagers (from 12 to 17 years including) only under medical supervision. NiQuitin is not recommended in children under 12 years of age for lack of security and effectiveness data. Method of administration: You have to put in your mouth a pill and let it melt. From time to time you have to move it from one side to another of the mouth until you get the complete dissolution (about 10 minutes). The pastel should not be chewed or swallowed whole. Do not eat or drink while you have a pill in your mouth. A support behavioural therapy generally improves success rates.

Conservation

Store in the original packaging to protect the product from moisture.

Warnings

The risks associated with the use of nicotinic replacement therapy (TNS) are widely overcome by the well-known dangers of continuous smoking. Subjects dependent on smoking, with recent myocardial infarction, unstable or ingravescent angina, including Prinzmetal angina, severe heart arrhythmias, uncontrolled hypertension or a recent cerebrovascular event should be encouraged to stop smoking immediately through non-pharmacological interventions (such as psychological support therapy). If this approach fails, you can consider the use of NiQuitin, but, since the safety data on this group of patients are limited, the start of the therapy should only take place under strict medical control. Diabetes mellitus: it should be recommended for patients with diabetes mellitus to control blood glucose levels more frequently than usual after the beginning of the TNS, since the catecholamines released by nicotine can interfere with the metabolism of carbohydrates. Allergic reactions: susceptibility to angioedema and hives. For patients who have the following conditions, the risk-benefit ratio assessment must be done by a specialist: Renal and hepatic insufficiency: use with caution in patients with moderate to severe liver failure and/or severe kidney failure, because clearance of nicotine and its metabolites may be reduced, with the potential risk of an increase in unwanted effects. Phochromocytoma and uncontrolled hyperthyroidism: use with caution in patients who have uncontrolled hyperthyroidism and feochromocytoma since nicotine causes the release of catecholamines. Gastrointestinal disorders: nicotine ingestion can exacerbate symptoms in patients suffering from esophagitis and gastric or peptic ulcer, so, in these subjects, oral preparations for TNS must be used with caution. It has also been reported ulcerative stomatitis. Convulsive crisis: use with caution in subjects taking anti-convulsive therapy or with a history of epilepsy as cases of seizures were reported in association with nicotine. Danger for small children: quantity of nicotine tolerated by adult smokers and adolescents can cause severe toxicity in small children with possible fatal outcome. Products containing nicotine must be kept out of reach of children, in order to prevent improper use, handling or ingested. Stop smoking: aromatic polycyclic hydrocarbons contained in tobacco smoke induce the metabolism of drugs catalyzed by CYP 1A2 (and perhaps by CYP 1A1). The suspension of smoking can therefore induce a slowing down in metabolism resulting in increased plasma levels of such drugs. Dependency TNS: dependence on TNS is rare and at the same time less harmful and easier to interrupt than that caused by smoking. Sodium: This medicine contains less than 1 mmol (23 mg) per pill and can therefore be declared sodium free. During an attempt to stop smoking, the consumer should not alternate NiQuitin with nicotine tires, as pharmacokinetics data indicate a greater nicotine availability with NiQuitin than the tires.

Interactions

No interaction studies have been conducted. Nicotine could enhance the hemodynamic effects of adenosine. Stop smoking may require the adjustment of certain pharmacological therapies.

Effects

The TNS may cause adverse reactions similar to those associated with nicotine administered by other ways, including smoking. Such reactions can be attributed to the pharmacological effects of nicotine, some of which are dose-dependent. It has not been proven that, at recommended doses, NiQuitin causes serious side effects. The excessive use of NiQuitin by those who are not accustomed to inhaling tobacco smoking may cause nausea, feeling of fainting or headache. Some of the reported symptoms, such as depression, irritability, anxiety, increased appetite and insomnia, can be associated with abstinence from smoking. Persons who stop smoking with any method can develop headaches, dizziness, sleep disorders, increased cough or cold. Adverse reactions are listed below, according to the classification for systems and organs and by frequency. The frequencies are defined as: very common (≥1/10), common (from ≥1/100 to Classification for systems and organs Reaction Adverse/Events Immune system disorders - Very rare Anaphylactic reactions Not known Hypersensitivity Psychiatric disorders - Town Irritability, anxiety, sleep disorders, among which abnormal dreams Not common Nervosism, depression Diseases of the nervous system   Town chiefs; cephalery Not known Tremore, dysgeusia, paresthesia of the mouth, convulsive crisis* Heart disease   Not common palpitations; tachycardia Respiratory, chest and mediastinic pathologies   Town cough; sore throat Not known Dispense Gastrointestinal diseases   Very common nausea; mouth/mouth irritation and tongue Town vomiting, diarrhea, gastrointestinal disorders, flatulence, hiccups, gastric pyrosis, dyspepsia Not known Disfaction, eruption, salivary hypersecretion Pathologies of skin and subcutaneous tissue   Not common Skin rash Not known Angioedema, itching, erythema, hyperhydrosis Systemic pathologies and conditions for administration   Not common Fatigue, malaise, chest pain Not known Simil flu disease ** Infections and infestations   Town Pharisees * observed in patients taking anticonvulsive therapy or with a history of epilepsy. **these events may also be due to the symptoms of suspension following the cessation of smoking. 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

The minimum lethal dose of nicotine in a man who did not develop tolerance was estimated between 40 and 60 mg. In children, even small amounts of nicotine can be dangerous and can be fatal. A suspected nicotine poisoning in a child must be considered a medical emergency and should be treated immediately. Synonyms: signs and symptoms from overdose of tablets to nicotine are the same as those from acute poisoning by nicotine included pallor, cold sweating, salivation, nausea, vomiting, abdominal pain, diarrhea, headache, dizziness, hearing and sight disorders, tremor, mental confusion and weakness. Disposable, hypotension, respiratory failure, accelerated pulse, weak or irregular, circulatory collapse and seizures (including terminal convulsions) can arise with high overdose. Treatment: in case of overdose (e.g. too many tablets to nicotine ingested) the user must contact the doctor immediately. Any form of nicotine intake must be interrupted immediately and the patient must be treated symptomaticly. If necessary, you should practice artificial breathing with oxygen. Active carbon reduces gastrointestinal absorption of nicotine.

Pregnancy: Pregnant smoking is associated with risks such as intrauterine growth delay, premature birth or perinatal mortality. Stop smoking is the most effective single intervention to improve the health of both the smoking mother and her child. First you reach the abstinence better. The ideal would be to stop smoking during pregnancy without the help of TNS. However, women who cannot stop by themselves, the doctor may recommend resorting to TNS as support in an attempt to stop smoking. The risk for the fetus linked to the use of TNS is less than that associated with tobacco smoke, thanks to a maximum plasma concentration of lower nicotine and the absence of exposure to polycyclic hydrocarbons and carbon monoxide. In any case, as nicotine passes to the fetus by altering the respiratory movements and has a dose-dependent effect on the fetus-placent circulation, the decision to resort to the TNS must be taken as early as possible during pregnancy. The objective should be to use the TNS only for 2-3 months. Products that release nicotine intermittently are preferable as they generally provide a lower daily dose of nicotine than patches. However, the latter are recommended for women who suffer from nausea during pregnancy. Breastfeeding: The nicotine that comes from smoke and TNS she finds herself in breast milk. However, the concentration of nicotine to which the child is exposed with the TNS is relatively low and less harmful than passive smoking to which the same would otherwise be exposed. During breastfeeding it would be ideal to stop smoking without the help of TNS. However, to women who fail to stop by themselves, the doctor may recommend resorting to TNS as support in an attempt to stop smoking. Use of preparations TNS which release nicotine intermittently, compared to patches, can minimize the concentration of nicotine in breast milk since the time between the administration of TNS and breastfeeding can be more easily prolonged. Women should try to breastfeed immediately before hiring the TNS.

Fertility:

Studies in male rats have shown that nicotine can decrease the weight of the testicle, cause a reversible decrease in the number of Sertoli cells with damage of spermatogenesis, and result in various changes in the epididymis and deferent vessels. However, similar effects were not reported in men.

Source: Farmadati