Nicotinell Mint 1mg 36 tablets to Suck

Nicotinell Mint (1 Mg, 36 Lozenges)
Active ingredient: Nicotine

Nicotinell Mint is available in the form of lozenges, indicated to reduce nicotine withdrawal symptoms and facilitate smoking cessation. Its use helps smokers to quit the habit, providing the necessary amount of nicotine to reduce withdrawal symptoms.

ACTION AND MECHANISM
Nicotine is an agonist of nicotinic cholinergic receptors, located mainly in the autonomic ganglia, adrenal medulla, neuromuscular plaque and central nervous system. Administration of nicotine through lozenges simulates the effect of nicotine in tobacco and relieves the symptoms of withdrawal syndrome, which include insomnia, anxiety, irritability and increased appetite. This treatment allows a progressive reduction of dependence until the body can do without nicotine.

PHARMACOKINETICS
Tablets to suck

• Absorption : Nicotine is released uniformly when the tablets are sucked and is rapidly absorbed. Part of the ingested nicotine is inactivated in the stomach and intestine, undergoing an intense first-pass effect in the liver. After administration of a 1 mg tablet, a maximum concentration (Cmax) of 10.6 ng/ml is reached in 45 minutes.
• Distribution : Low binding to plasma proteins (5%). Nicotine crosses the blood-brain and placental barriers and is excreted in breast milk.
• Metabolism : Nicotine is mainly metabolized in the liver, giving rise to more than 20 metabolites, the main one being cotinine.
• Elimination : It is eliminated mainly by hepatic metabolism and urinary excretion. Up to 10% of the dose is excreted unchanged in urine. The elimination half-life (t1/2) is 1-3 hours.

INDICATIONS

• Adjuvant treatment in smoking cessation to relieve nicotine withdrawal symptoms.

POSOLOGY

• Adults : The dosage varies according to the dependency.
  • Low to moderate dependence (less than 20 cigarettes per day): 1 mg tablets.
  • High dependence (more than 30 cigarettes daily): 2 mg tablets.
  • Moderate to high dependence (20-30 cigarettes daily): 1 or 2 mg depending on the patient's characteristics.
  • One tablet is recommended every 1-2 hours when you feel the urge to smoke. The usual daily dose is 8-12 tablets, with a maximum of 30 1 mg tablets per day.
  • The duration of treatment should be at least 3 months, gradually reducing the dose.

RULES FOR CORRECT ADMINISTRATION

• Quit smoking completely during treatment to avoid high nicotine levels.
• Avoid consuming acidic beverages (coffee, soft drinks) during the 15 minutes before administration, as they reduce the absorption of nicotine.
• The tablets should be sucked slowly until the taste becomes intense, then placed between the gum and the wall of the mouth. This process is repeated for about 30 minutes.

ADVICE TO THE PATIENT

• Reduce the dose gradually to avoid relapses.
• Report any symptoms of overdose, such as nausea, vomiting, dizziness, or palpitations to your doctor.
• Do not smoke during treatment, or combine lozenges with other nicotine products.
• For lactating women, administer the tablet at least two hours before breastfeeding the baby.
• It is not recommended to use the treatment for more than 6 months.

CONTRAINDICATIONS

• Hypersensitivity to any component of the medication.
• Non-smokers or occasional smokers.

PRECAUTIONS

• Renal impairment : Nicotine accumulation may cause adverse effects. Patients with moderate renal impairment should be monitored and use should be avoided in severe cases.
• Hepatic impairment : Caution in patients with moderate hepatic impairment. Avoid use in severe cases.
• Heart disease : Nicotine may worsen cardiovascular conditions. In patients with heart disease, the need for treatment should be properly assessed and any signs of worsening should be monitored.
• Hyperthyroidism, pheochromocytoma : Nicotine may worsen these conditions.
• Peptic ulcer : Nicotine delays the healing of gastroduodenal ulcers, use only if the benefits outweigh the risks.
• Dependence : Nicotine can cause dependence, so it is recommended to reduce its use gradually.

PRECAUTIONS REGARDING EXCIPIENTS

• Contains aspartame, which is a source of phenylalanine, which may be harmful in patients with phenylketonuria.
• Contains sodium salts, take into account in low sodium diets.

INTERACTIONS

• Tobacco smoke is an enzyme inducer, which can alter the effects of certain medications. When quitting smoking, it may be necessary to adjust the dosage of drugs such as oral anticoagulants, benzodiazepines, estrogens, theophylline, among others.
• Caution when combining nicotine with adrenergic drugs or bupropion, as it may increase the risk of hypertension.

PREGNANCY

• Safety in humans : Smoking during pregnancy may cause fetal harm, including growth retardation and increased perinatal mortality. Nicotine replacement therapy should only be used if there are no safer alternatives and always under medical supervision.
• In the third trimester, nicotine can cause changes in fetal heart rate, so it should be used with caution and under medical supervision.

LACTATION

• Nicotine is excreted in breast milk and can be absorbed by the infant. It is recommended not to smoke or use nicotine during breastfeeding. If necessary, tablets or chewing gum should be used after breastfeeding, waiting at least 2 hours before breastfeeding again.

CHILDREN

• Safety has not been evaluated for children under 18 years of age, so its use is not recommended. Small doses of nicotine can be dangerous for children, and should be kept out of their reach.

ADVANCED AGE

• No significant differences have been observed in the elderly. However, due to the higher prevalence of heart disease, caution is recommended in this group.

ADVERSE REACTIONS

• Digestive : Dyspepsia, nausea, vomiting, gastric hyperacidity, diarrhea, abdominal pain.
• Neurological : Dizziness, headache, insomnia, decreased concentration, irritability.
• Cardiovascular : Palpitations, hypertension, edema. Rarely, arrhythmias or acute myocardial infarction.
• Respiratory : Cough, dyspnea.
• Dermatological : Hypersensitivity reactions such as angioedema, contact dermatitis, erythema.
• Osteomuscular : Myalgia, musculoskeletal pain.

OVERDOSE

• Nicotine is toxic, and high doses can be fatal, especially in children. Symptoms include nausea, vomiting, diarrhea, abdominal pain, headache, dizziness, tachycardia, paleness, and in severe cases, lethargy, seizures, or coma.
• Treatment : Discontinue administration and promote elimination of the drug by induced vomiting, gastric lavage and activated charcoal. Treat symptoms symptomatically, administering benzodiazepines for seizures and beta-blockers for tachycardia.

Leaflet Nicotinell Mint 1mg 36 tablets to Suck