Nicotinell 2 mg mint tablet

Reducing tobacco consumption

NICOTINELL MINT 2 mg, lozenge should be used in periods between smoking, with the aim of prolonging smoke-free periods, and with the intention of reducing cigarette consumption as much as possible. The number of cigarettes should be progressively replaced with NICOTINELL MINT 2 mg, lozenge.

If a reduction of at least 50% in daily cigarette consumption has not been achieved after 6 weeks of treatment, it is recommended to seek advice from a healthcare professional.

An attempt to stop smoking should be considered as soon as the smoker feels ready, but no later than 4 months after the start of the treatment. After this period, the number of lozenges should be gradually reduced, for example, by stopping one lozenge every 2-5 days. If a complete cessation attempt has failed 6 months after the start of treatment, it is recommended to seek advice from a healthcare professional. Regular use of NICOTINELL MINT 2 mg, lozenge after 6 months is generally not recommended. Some former smokers may need longer treatment to avoid returning to smoking.

The advice of a healthcare professional can assist smokers in quitting smoking.

Pediatric population

NICOTINELL MINT 2 mg, lozenge should not be administered in adolescents (12-17 years) without the advice of a healthcare professional. There is no experience of administering this medication in adolescents under 18 years old.

NICOTINELL MINT 2 mg, lozenge should not be administered in children under 18 years old.

Kidney and liver insufficiency

This medication should be used with caution in patients with moderate to severe renal insufficiency and / or moderate to severe hepatic insufficiency, as the clearance of nicotine or its metabolites may be decreased with the possibility of increased side effects.

Advice can improve the chances of quitting.

Usage tips:

· Suck the tablet until the taste becomes strong.

· Then place the tablet between the gum and the cheek.

· Start sucking the tablet again when the taste has faded.

· This process will be individually adapted and must be repeated until the tablet is completely dissolved (about 30 minutes).

Consumption of acidic drinks such as coffee or soda can decrease the absorption of nicotine through the oral mucosa. These drinks should be avoided for 15 minutes prior to taking the sucking tablet. Do not eat or drink with the sucking tablet in your mouth.

4.3. Contraindications

· Hypersensitivity to nicotine or any of the excipients mentioned in section 6.1.

· Non-smoking subjects.

4.4. Special warnings and precautions for use

Cardiovascular diseases: in case of recent myocardial infarction, unstable or worsening angina (including Prinzmetal angina), severe cardiac rhythm disorder, unstable arterial hypertension or recent cerebrovascular accident, it is always recommended first to completely stop smoking without nicotine replacement therapy.

In case of failure in these smokers, the use of NICOTINELL MENTHE sucking tablets should be considered; however, clinical safety data in these patients are limited, and the initiation of treatment should only be done under medical supervision. In case of clinically significant increase in cardiovascular effects or others attributable to nicotine, the dose of nicotine should be reduced or the drug stopped.

Use NICOTINELL sucking tablets with caution in patients with hypertension, stable angina, cerebrovascular disorder, occlusive peripheral arterial diseases, heart failure, hyperthyroidism, or pheochromocytoma.

Diabetes mellitus: blood glucose may be more variable when stopping smoking, with or without nicotine replacement therapy. Therefore, it is important for diabetics to closely monitor their blood glucose levels when using this product.

Kidney or liver insufficiency: moderate to severe liver insufficiency and/or severe renal insufficiency.

Convulsions: The potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anticonvulsant therapy or with a history of epilepsy, as cases of seizures have been reported in association with nicotine.

In these patients, the complete cessation of smoking, without nicotine replacement therapy, should first be recommended.

Gastrointestinal diseases: swallowed nicotine can exacerbate symptoms in subjects suffering from esophagitis, inflammation of the mouth or pharynx, gastritis or gastric or peptic ulcers.

Keep out of sight and reach of children.

Danger in young children: doses of nicotine tolerated in adult smokers can cause serious or even fatal poisoning in young children (see section 4.9).

4.5. Special warnings and precautions for use

Specific warnings related to excipients:

NICOTINELL MENTHE sucking tablets contain aspartame, maltitol, and sodium.

Each NICOTINELL MENTHE 2 mg sucking tablet contains 10 mg of aspartame (E951), a source of phenylalanine equivalent to 5 mg per intake; which can be dangerous in subjects with phenylketonuria.

NICOTINELL MENTHE 2 mg sucking tablets contain maltitol (E965), a source of fructose.

As a result:

• Patients with rare hereditary fructose intolerance should not take this medicine.
• Patients may experience a mild laxative effect.

The caloric value of maltitol is 2.3 kcal/g.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet and is considered "sodium-free".

4.5. Interactions with other medicinal products and other forms of interaction

Drug interactions: There is no data on potential interactions between nicotine-containing sucking tablets and other medicinal products.

Other effects reported with smoking include a reduction in the analgesic effect of propoxyphene, a decrease in the diuretic effect of furosemide, a decrease in the pharmacological effect of propranolol on blood pressure and heart rate, and a decrease in the anti-ulcer effect of H2 antagonists.

Tobacco and nicotine can lead to increased blood concentrations of cortisol and catecholamines, such as a decrease in the effect of nifedipine or adrenergic antagonists and an increase in the effect of adrenergic agonists.

The increased subcutaneous absorption of insulin that occurs when smoking is stopped may require a reduction in the insulin dose.

4.6. Fertility, pregnancy, and lactation

Pregnancy:

Smoking during pregnancy is associated with risks such as intrauterine growth retardation, preterm delivery, or stillbirth. Smoking cessation is the most effective intervention to improve the health of the pregnant woman and her baby. The earlier smoking cessation occurs, the better. Nicotine is transmitted to the fetus and affects its respiratory movements and circulation. The effect on circulation is dose-dependent.

Pregnant women should first be advised to quit smoking without the aid of nicotine replacement therapy. If unsuccessful, the use of nicotine replacement therapy should only be considered after the advice of a healthcare professional.

Lactation:

Nicotine passes into breast milk in quantities that could affect the child, including at therapeutic doses.

Therefore, NICOTINELL MENTHE 2 mg sucking tablets, like smoking, should be avoided during breastfeeding.

If smoking cessation is not fully achieved, the use of the sucking tablet during breastfeeding should only be decided upon after the advice of a healthcare professional.

If using this medicine during breastfeeding, suck the NICOTINELL MENTHE 2 mg tablet immediately after breastfeeding and do not take it for the two hours preceding the next breastfeeding session.

Fertility:

Smoking increases the risk of infertility in both women and men. Both in men and in animals, nicotine has been shown to impair sperm quality. Reduced fertility has been demonstrated in animals.

4.7. Effects on ability to drive and use machines

There is no evidence of risk regarding driving vehicles or using machines during treatment with the recommended doses of sucking tablets. However, it should be taken into consideration that smoking cessation can cause behavioral changes.

4.8. Adverse Reactions

Nicotine from the lozenges can cause adverse reactions similar to those of nicotine absorbed through smoking, due to the pharmacological effects of nicotine, which are dose-dependent. Non-dose-dependent adverse reactions include hypersensitivity, angioedema, and anaphylactic shock.

Most reported adverse reactions occur during the first 3 or 4 weeks of treatment.

Nicotine from the lozenges can sometimes cause mild throat irritation and increased salivation at the beginning of treatment. Swallowing too much nicotine may cause hiccups. Sensitive individuals may experience mild symptoms of dyspepsia or heartburn initially. These symptoms can be reduced by sucking the lozenge more slowly. Excessive consumption of lozenges by individuals who did not inhale tobacco smoke may cause nausea, dizziness, and headache.

The occurrence of aphthous ulcers may be more frequent when quitting smoking.

The following adverse reactions detailed in Table 1 are relevant to all oral forms of nicotine.

The adverse reactions are listed below by organ system and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).

Table 1 shows adverse reactions identified from a randomized, double-blind, placebo-controlled clinical trial involving 1818 patients. Adverse reactions reported in this study were considered when the incidence in the nicotine 2 mg or 4 mg group was higher than that in the corresponding placebo group. Frequencies are calculated from safety data of this study.

Certain symptoms such as dizziness, headache, and insomnia may be related to smoking cessation and may be due to insufficient nicotine dose.

Herpes labialis (cold sores) may occur when quitting smoking, but their relationship with nicotine replacement therapy is not established.

The patient may remain dependent on nicotine after quitting smoking.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the product. Healthcare professionals are encouraged to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

In the case of overdose, symptoms corresponding to heavy tobacco consumption may be observed.

Even low doses of nicotine are toxic in children and can cause symptoms of intoxication that can be fatal. In case of suspicion of poisoning in children, immediate medical attention should be sought.

An overdose with NICOTINELL MENTHE 2 mg lozenges can only occur if multiple lozenges are consumed simultaneously. Generally, the toxicity of nicotine after ingestion is minimized by the early occurrence of nausea and vomiting following excessive nicotine exposure.

Signs and symptoms of overdose should be the same as those of acute nicotine poisoning, including general weakness, pallor, excessive sweating, hypersalivation, sore throat, nausea, vomiting, diarrhea, abdominal pain, auditory and visual impairments (sensory disturbances), headache, tachycardia and cardiac arrhythmia, dyspnea, dizziness, tremors, confusion, and asthenia. Prostration, hypotension, cardiovascular collapse, respiratory failure, and terminal seizures may occur in cases of significant overdose.

Management of Overdose

In the case of overdose (e.g., ingestion of too many lozenges), immediate medical assistance is required. Nicotine intake should be immediately discontinued, and the patient should be treated symptomatically and vital signs monitored.

Further management should be clinically indicated or as recommended by the national poison control center.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: MEDICAMENT USED IN NICOTINE DEPENDENCE, ATC code: N07BA01.

Mechanism of action

Nicotine, the main alkaloid in tobacco products, is a naturally occurring substance that acts on the autonomic nervous system. It is an agonist of nicotinic receptors in the central and peripheral nervous systems, exerting pronounced effects on the central nervous system and cardiovascular system. When consumed through tobacco, nicotine creates dependence, resulting in a sense of craving and other withdrawal symptoms upon cessation of administration. These withdrawal symptoms include a strong urge to smoke, dysphoria, insomnia, irritability, frustration or anger, anxiety, difficulty concentrating, restlessness, and increased appetite or weight gain. The lozenges replace a portion of the nicotine that would have been administered through tobacco and reduce the intensity of withdrawal symptoms and strong cravings to smoke.

5.2. Pharmacokinetic properties

Absorption

The amount of absorbed nicotine depends on the amount released and absorbed through the buccal mucosa.

The majority of nicotine from NICOTINELL MENTHE 2 mg lozenges is absorbed through the buccal mucosa.

Due to the swallowing of saliva containing nicotine, a certain proportion of it reaches the stomach and intestine, where it is inactivated. Due to first-pass hepatic metabolism, systemic bioavailability of nicotine is low.

Therefore, a high and rapid systemic concentration, as achieved through smoking, is rarely attained during treatment with NICOTINELL MInt.