Niquitinmint 60 tablets of 2 mg to quit smoking

Product Description

Medication used for nicotine addiction.

Indications

Niquitinmint is indicated in the treatment of tobacco dependence to reduce nicotine withdrawal symptoms. Permanent cessation of tobacco use is the ultimate goal. Niquitinmint should preferably be used in conjunction with a behavioral support program.

Composition

Active ingredients

Each lozenge contains: nicotine 2 mg (as nicotine resinate).

Excipients

Mannitol (E421), sodium alginate (E401), xanthan gum (E415), potassium bicarbonate (E501), calcium polycarbophil, anhydrous sodium carbonate (E500), potassium acesulfame (E950), magnesium stearate (E470b), mint flavor, sucralose.

Directions for use and Dosage

Dosage

Smokers should make every effort to stop smoking completely during treatment with Niquitinmint. The dosage of the lozenge to be taken depends on the individual's smoking habits. Niquitinmint 2 mg is indicated for smokers of 20 cigarettes or fewer per day. Supportive behavioral therapy generally improves success rates. Adults (18 years and older).
Abrupt cessation of smoking: Take one lozenge whenever you feel a strong urge to smoke. A sufficient number of lozenges should be used each day, generally 8-12, up to a maximum of 15. Continue using the lozenges for up to 6 weeks to break the habit of smoking, then gradually reduce consumption. When daily consumption is 1-2 lozenges, treatment should be discontinued. To help maintain a smoke-free lifestyle after treatment has ended, you can take one lozenge in situations where you feel strongly tempted to smoke. Those taking the lozenges for more than 9 months are advised to seek further advice and help from their doctor or pharmacist. Recommended treatment regimen.
Weeks 1 to 6: Initial treatment period: 1 lozenge every 1 to 2 hours; it is recommended to take at least 8 lozenges per day.
Weeks 7 to 9: Reduce the treatment period to 1 lozenge every 2-4 hours.
Weeks 10 to 12: Reduce the treatment period to 1 lozenge every 4-8 hours; smokers should not exceed 15 lozenges per day.
To help you quit smoking for the next 12 weeks: 1-2 lozenges per day should be taken only on occasions when you feel a strong urge to smoke.
Gradual smoking cessation: For smokers who are unwilling or unable to quit smoking suddenly. Take one lozenge each time you feel a strong urge to smoke to reduce the urge as much as possible. Reduce the number of cigarettes smoked and abstain from smoking for as long as possible. The number of lozenges per day varies and depends on the patient's needs. However, 15 lozenges per day should not be exceeded. If a reduction in cigarette consumption is not achieved after 6 weeks of treatment, a healthcare professional should be consulted. Reduced tobacco consumption should lead to complete smoking cessation. This should be done as soon as possible. Once the number of cigarettes has been reduced to a level at which the user feels able to quit completely, the "abrupt cessation" program as described in the previous section should be initiated.
If the attempt to completely quit smoking is not started within 6 months of starting treatment, it is advisable to consult a healthcare professional. Gradual cessation is not recommended in pregnant women.
Paediatric population: Niquitinmint may cause serious side effects. Niquitinmint should be used by adolescents (12 to 17 years inclusive) only under medical supervision. Since available data are limited, the duration of Nicotine Replacement Therapy (NRT) in this age group should not exceed 12 weeks. Niquitinmint is contraindicated in children under 12 years.
Method of administration: Place one lozenge in your mouth and let it dissolve. Occasionally move it from one side of your mouth to the other until it is completely dissolved (about 10 minutes). The lozenge should not be chewed or swallowed whole. Do not eat or drink while holding a lozenge in your mouth. The duration of treatment depends on the needs of each smoker. In general, the duration of treatment with oral forms of nicotine is 2-3 months, after which it can be gradually reduced. When daily use is reduced to 1-2 doses, administration of the drug should be discontinued.

Warnings

The risks associated with the use of nicotine replacement therapy (NRT) are far outweighed by the well-known dangers of continued smoking.
Smoking-dependent individuals with recent myocardial infarction, unstable or worsening angina, including Prinzmetal's angina, serious cardiac 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, the use of Niquitinmint may be considered, but as safety data in this patient group are limited, initiation of therapy should only occur under close medical supervision. If there is a clinically significant increase in cardiovascular or other nicotine-related effects, lozenge doses should be reduced or discontinued.
For patients with the following conditions, a risk-benefit assessment should be performed by a specialist: stable cardiovascular disease such as hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, and heart failure.
Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood glucose levels more closely. more frequently than usual after starting NRT, since the catecholamines released by nicotine may interfere with carbohydrate metabolism.
Allergic reactions: Susceptibility to angioedema and urticaria.
Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment, as the clearance of nicotine and its metabolites may be decreased, with the potential risk of increased adverse effects.
Pheochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism and pheochromocytoma, as nicotine causes the release of catecholamines.
Gastrointestinal disorders: Nicotine ingestion may exacerbate symptoms in patients with esophagitis and gastric or peptic ulcers, therefore, oral NRT preparations should be used with caution in these patients. Ulcerative stomatitis has also been reported.
Seizures: Use with caution in individuals taking anticonvulsant therapy or with a history of epilepsy, as cases of convulsions have been reported in association with nicotine.
Danger to young children: Amounts of nicotine tolerated by adult and adolescent smokers can cause serious toxicity in young children, possibly resulting in death. Nicotine-containing products should be kept out of the reach of children to prevent misuse, handling, or ingestion.
Smoking cessation: Polycyclic aromatic hydrocarbons in tobacco smoke induce drug metabolism catalyzed by CYP1A2 (and perhaps CYP1A1). Stopping smoking may therefore slow down the metabolism, resulting in increased plasma levels of these drugs. NRT dependence: NRT dependence is rare and, at the same time, less harmful and easier to break than that caused by smoking. Mannitol: Niquitinmint contains mannitol, which may have a mild laxative effect. Sodium: This medicine contains less than 1 mmol (23 mg) per lozenge, i.e., essentially sodium-free. When attempting to quit smoking, the user should not alternate Niquitinmint with nicotine gum, as pharmacokinetic data indicate greater nicotine availability with Niquitinmint than with gum.

Undesirable effects

NRT may cause adverse reactions similar to those associated with nicotine administered by other routes, including smoking. These reactions may be attributed to the pharmacological effects of nicotine, some of which are dose-dependent. Niquitinmint has not been shown to cause serious adverse effects at recommended doses. Excessive use of Niquitinmint by those unaccustomed to inhaling tobacco smoke may cause nausea, faintness, or headache. Some of the reported symptoms, such as depression, irritability, anxiety, increased appetite, and insomnia, may be associated with smoking withdrawal. People who quit smoking by any means may develop headaches, dizziness, trouble sleeping, and increased coughing or colds. Adverse reactions are listed below, by system organ class and frequency.

Frequencies are defined as:

• very common (>=1/10);
• common (from >=1/100 to <1/10);
• uncommon (from >=1/1,000 to <1/100);
• rare (from >=1/10,000 to <1/1,000);
• very rare (<1/10,000);
• not known (frequency cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

System disorders immune

• Very rare: anaphylactic reaction;
• Not known: hypersensitivity.

Blood and lymphatic system disorders

• Uncommon: gingival bleeding; epistaxis.

Psychiatric disorders

• Common: insomnia, anxiety, irritability, increased appetite, anger, anxiety disorder, abnormal dreams;
• Uncommon: appetite disturbance, mood swings, sleep disturbances.

Infections and infestations

• Common: pharyngitis.

Nervous system disorders

• Common: headache, dizziness;
• Uncommon: hypoaesthesia; parageusia, dysgeusia, taste perversion;
• Not known: seizure, tremor.

Cardiac disorders

• Uncommon: worsening of palpitations, palpitations, tachycardia.

Vascular disorders

• Uncommon: angiopathy, flushing, red skin.

Respiratory, thoracic and mediastinal disorders

• Common: cough;
• Uncommon: laryngospasm, asthma aggravated, lower respiratory tract infection, nasal irritation, throat irritation, nasal congestion; not known: dyspnoea.

Gastrointestinal disorders

• Very common: nausea; common: vomiting, dyspepsia, heartburn, indigestion, hiccups, mouth irritation and ulceration, tongue ulceration, diarrhoea, eructation, flatulence, dry mouth, constipation;
• Uncommon: peptic ulcer, dysphagia, aggravated dyspepsia, duodenogastric reflux, hiatus hernia, esophagitis, eructation, ulceration of the oral mucosa, borborygmus, dry lips, dry throat, tongue disorder, toothache;
• Not known: salivary hypersecretion. Skin and subcutaneous tissue disorders.
• Uncommon: erythema, pruritus, rash, localised skin reaction, hyperhidrosis; not known: angioedema.

Musculoskeletal and connective tissue disorders

• Uncommon: jaw pain.

Renal and urinary disorders

• Uncommon: nocturia.

General disorders and administration site conditions

• Uncommon: effects of overdose, pain, pain in the legs, peripheral oedema;
• not known: asthenia, fatigue, malaise, flu-like syndrome. observed in patients taking anticonvulsant therapy or with a history of epilepsy.

Individuals with a tendency to experience indigestion problems may initially suffer from mild indigestion or heartburn: chewing gum more slowly usually helps to overcome this problem. These events may also be due to withdrawal symptoms following smoking cessation. Paediatric population (12 to 17 years inclusive): There are no specific adverse event data for this population. However, the frequency, type and severity of adverse reactions in adolescents are likely to be the same as those in adults, based on a pharmacokinetic study that showed a pharmacokinetic profile in adolescents similar to that in adults. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product.

Pregnancy and breastfeeding

Pregnancy

Smoking during pregnancy is associated with risks such as intrauterine growth retardation, premature birth, and perinatal mortality. Quitting smoking is the single most effective intervention to improve the health of both the smoking mother and her baby. The earlier abstinence is achieved, the better. Ideally, it would be possible to quit smoking during pregnancy without the aid of NRT. However, for women who are unable to quit on their own, the doctor may recommend using NRT as an aid in an attempt to quit smoking. The risk to the fetus associated with the use of NRT is lower than that associated with tobacco smoking, due to a lower maximum plasma nicotine concentration and the absence of exposure to polycyclic hydrocarbons and carbon monoxide. In any case, since nicotine passes to the fetus, altering respiratory movements and having a dose-dependent effect on the fetoplacental circulation, the decision to use NRT should be made as early as possible during pregnancy. Gradual cessation methods of smoking cessation should be explicitly avoided during pregnancy. The goal should be to use NRT only for 2-3 months. Intermittently releasing nicotine products are preferable as they generally provide a lower daily dose of nicotine than patches. However, the latter are recommended for women who experience nausea during pregnancy. In the absence of specific studies, combination therapy with patches and oral forms is not recommended during pregnancy unless the healthcare provider deems it necessary to ensure abstinence.

Breastfeeding

Nicotine from smoking and NRT is found in breast milk. However, the concentration of nicotine to which the baby is exposed with NRT is relatively low and less harmful than the secondhand smoke to which the baby would otherwise be exposed. During breastfeeding, it would be ideal to be able to quit smoking without the aid of NRT. However, for women who are unable to quit on their own, the doctor may recommend using NRT as an aid in an attempt to quit smoking. The use of NRT preparations that release nicotine intermittently, compared to patches, may minimize the concentration of nicotine in breast milk since the time between NRT administration and breastfeeding can be more easily prolonged. Women should try to breastfeed immediately before taking the product. In the absence of specific studies, combination therapy with patches and oral forms is not recommended during breastfeeding unless the healthcare professional deems it necessary to ensure abstinence.

Fertility

There are no human data on the effects of nicotine on fertility. In animal studies, nicotine has been shown to have negative effects on both the female and male reproductive systems. However, the clinical significance of these effects on fertility is unknown.

Format

60 2 mg Lozenges