Nicorette winter mint: detailed information

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NIKORETTE® WINTER MINT (NICORETTE® Winter MINT)

Composition:

Active substance: nicotine;

One therapeutic chewing gum contains a nicotine-polymer complex – 11.0 mg or 22.0 mg, corresponding to 2 mg or 4 mg of nicotine;

Excipients: Core: chewing gum base, xylitol, peppermint oil, sodium carbonate anhydrous, sodium hydrogen carbonate (only in the 2 mg dosage), potassium acesulfame, levomenthol, light magnesium oxide, quinoline yellow (E 104) (only in the 4 mg dosage); Sub-coating: Winterfresh flavor, hypromellose, sucralose, polysorbate 80; Hard coating: xylitol, pregelatinized starch, titanium dioxide (E 171), Winterfresh flavor, carnauba wax, quinoline yellow (E 104) (only in the 4 mg dosage).

Pharmaceutical form. Therapeutic chewing gum.

Main physicochemical properties: white (for 2 mg) or light yellow (for 4 mg) coated square tablets, approximately 15×15×6 mm in size.

Pharmacotherapeutic group. Medicinal product for treatment of nicotine dependence.

ATC code N07BA01.

Pharmacological Properties

Pharmacodynamics

Abrupt cessation of nicotine-containing products after a prolonged period of daily use leads to a characteristic withdrawal syndrome: dysphoria or depression; insomnia; irritability; frustration or aggression; restlessness; difficulty concentrating; impatience; cardiovascular disturbances; increased appetite or weight gain. Nicotine dependence is also a prominent clinical symptom observed during withdrawal syndrome.

Nicorette® Wintergreen helps prevent the development of withdrawal syndrome in individuals who have stopped smoking; it helps prevent the development of nicotine dependence.

When used at the appropriate dose, Nicorette® Wintergreen helps control body weight after smoking cessation.

The composition of Nicorette® Wintergreen chewing gum includes excipients that have properties to remove dental plaque. Clinical data have shown that Nicorette® Wintergreen chewing gum has a whitening effect.

Pharmacokinetics.

The amount of absorbed nicotine depends on the quantity of nicotine released and that lost through swallowing. During gum chewing, nicotine is slowly released and absorbed through the oral mucosa. Systemic bioavailability of swallowed nicotine is low due to its hepatic utilization via the so-called "first-pass effect." Rapid attainment of high nicotine blood concentrations, as seen with smoking, is unlikely when using Nicorette®.

Typically, 1.4 mg of nicotine is released from the 2 mg gum or 3.4 mg of nicotine from the 4 mg gum.

Maximum blood concentration is reached after 30 minutes of chewing and at that point is comparable to the concentration achieved 20–30 minutes after smoking a cigarette of medium strength.

Clinical Characteristics.

Indications.

Treatment of tobacco dependence by reducing the need for nicotine and alleviating withdrawal symptoms; facilitating smoking cessation when there is motivation; assisting smokers who are unable to completely quit nicotine dependence to reduce the number of cigarettes smoked.

Contraindications.

Nicolette® Winter Mint is contraindicated in the following cases:

Hypersensitivity to nicotine or to any component of the product;
Recent myocardial infarction (within the past 3 months);
Unstable or progressing angina pectoris;
Prinzmetal's angina;
Severe cardiac arrhythmias;
Acute stroke.

Interaction with other medicinal products and other forms of interaction.

Smoking (but not nicotine itself) is associated with increased CYP1A2 enzyme activity. After smoking cessation, a decrease in the clearance of substrates of this enzyme may occur. This may lead to increased plasma levels of certain drugs; this effect may also be clinically significant for drugs with a narrow therapeutic window, such as theophylline, tacrine, clozapine, and ropinirole.

The plasma concentration of other drugs metabolized by CYP1A2 may also increase after smoking cessation; for example, this phenomenon may occur with imipramine, olanzapine, clomipramine, and fluvoxamine, but data confirming this effect are insufficient, and potential clinical consequences have not been studied.

Limited data suggest that the metabolism of flecainide and pentazocine may also be altered by smoking.

Nicotine may enhance the hemodynamic effects of adenosine, such as increased blood pressure and heart rate, as well as intensify pain response (chest pain resembling angina) caused by adenosine administration.

Special precautions for use

In smokers wearing removable dentures, difficulties may occur when chewing Nicorette® Wintergreen. The chewing gum may adhere to dental prostheses and occasionally damage them.

Nicorette® Wintergreen chewing gum should be used with caution in patients with severe cardiovascular disorders: peripheral arterial occlusive disease, cerebrovascular disorders, decompensated heart failure, stable angina pectoris, vasospasm, uncontrolled hypertension.

The physician should carefully weigh the risks and benefits in patients with the conditions listed below.

Smokers with recently sustained myocardial infarction (˂ 4 weeks), unstable or progressing angina, including Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled arterial hypertension, or recent stroke should be encouraged to quit smoking without pharmacological therapy (e.g., through psychotherapy). If this approach fails, use of Nicorette® Wintergreen chewing gum may be considered. Since safety data in these patient groups are limited, Nicorette® Wintergreen chewing gum should be used exclusively under close medical supervision.

Nicorette® Wintergreen chewing gum should be used with caution in patients with moderate or severe hepatic impairment, or severe renal impairment, as clearance of nicotine or its metabolites may be reduced, increasing the risk of adverse effects.

Nicotine, whether from chewing gum or smoking, may exacerbate symptoms in patients with esophagitis, gastric or peptic ulcers; therefore, Nicorette® Wintergreen chewing gum should be used cautiously in these patients. Cases of ulcerative stomatitis have been reported.

Nicotine, whether from chewing gum or from smoking, promotes the release of catecholamines from the adrenal glands. Therefore, Nicorette® Wintergreen chewing gum should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma.

Patients with diabetes who quit smoking and start nicotine replacement therapy should be monitored more closely for blood glucose levels than usual, as reduced nicotine-induced catecholamine release may affect carbohydrate metabolism.

Cessation of smoking may necessitate a reduction in insulin dosage in patients with diabetes.

Some patients continue to use Nicorette® Wintergreen chewing gum beyond the recommended period; however, the potential risk of long-term use of the gum is significantly lower than the continued risk of smoking.

Nicorette® Wintergreen chewing gum contains xylitol, which may have a laxative effect.

Caloric content: 2.4 kcal/g of xylitol, corresponding to 1.5 kcal and 1.4 kcal per piece (Nicorette® Wintergreen 2 mg and 4 mg, respectively).

Special considerations for the combined use of Nicorette® Wintergreen chewing gum and Nicorette® transdermal patch are the same as for each product individually (see the medical instructions for Nicorette® transdermal patch).

Seizures: Caution is advised in patients receiving anticonvulsant therapy or with a history of epilepsy, as seizures have been reported in association with nicotine use.

Potential for dependence. Dependence on nicotine products may occur. However, it is rare, less harmful to health than nicotine dependence from tobacco smoking, and easier to overcome.

Use during pregnancy or breastfeeding

Nicotine crosses the placenta and affects fetal respiratory activity and circulation. The circulatory effect is dose-dependent. Smoking during pregnancy may lead to reduced birth weight and increase the risk of pregnancy complications and perinatal mortality.

Cessation of nicotine use is the single most effective measure to improve the health of a pregnant smoker and her child, and the earlier this occurs, the better.

Pregnant women should be advised to stop smoking without using nicotine replacement therapy.

However, if a pregnant woman cannot quit smoking without pharmacological support (or this is considered unlikely), nicotine replacement therapy may be used, as the risk to the fetus is lower than that associated with continued smoking.

For nicotine replacement therapy in pregnancy, dosage forms with intermittent administration are preferred due to the possibility of lowering nicotine levels. However, in cases of nausea and/or vomiting, patches may be necessary and, if possible, should be removed at night, when the fetus is usually not exposed to nicotine.

Smoking can cause significant harm to the fetus or infant, and therefore should be discontinued. The risk to the fetus from using Nicorette® has not been fully studied. Continued smoking poses a more serious threat to the fetus than using nicotine-containing replacement therapy products.

Nicorette® chewing gum may be used during pregnancy only in cases of very high nicotine dependence and only upon a physician’s recommendation.

Nicotine freely passes into breast milk in amounts that may adversely affect the infant, even when used at therapeutic doses. Therefore, breastfeeding women should be advised to stop smoking without using nicotine replacement therapy. If this is not possible, use of Nicorette® Wintergreen chewing gum may be considered only upon a physician’s recommendation after careful assessment of the risk-benefit ratio.

Nicotine use during breastfeeding should be avoided. The relatively small amount of nicotine found in breast milk during nicotine replacement therapy is less dangerous to the infant than passive smoking. Intermittent-dose nicotine formulations may minimize the amount of nicotine in breast milk and allow breastfeeding when nicotine levels are lowest.

The product should be taken as soon as possible after breastfeeding.

Tobacco smoking in women delays conception and reduces the success rate of in vitro fertilization, significantly increasing the risk of infertility.

In men, tobacco smoking reduces sperm production, increases oxidative stress, and damages DNA. Spermatozoa from smokers have reduced fertilizing capacity.

There are no reliable data on the effects of nicotine on human reproductive function.

Effect on reproductive function

In contrast to the well-known adverse effects of tobacco smoking on conception and pregnancy in humans, the corresponding effects of nicotine used for therapeutic purposes are unknown. Currently, there are no specific recommendations regarding the need for female contraception in such cases. It is more appropriate for women attempting to conceive to abstain from both tobacco smoking and nicotine replacement therapy. Although tobacco smoking may negatively affect male fertility, there is no evidence supporting the need for contraceptive use by men during nicotine replacement therapy.

Ability to affect reaction speed when driving or operating machinery.

Caution is advised when driving or operating machinery, as use of Nicorette® may occasionally cause dizziness.

Method of Administration and Dosage

Nicorette® Wintergreen chewing gum 2 mg can be used as monotherapy or in combination with Nicorette® transdermal patch.

Nicorette® Wintergreen chewing gum 4 mg is used as monotherapy.

Do not eat or drink while chewing the gum. Beverages that lower the pH of the oral cavity, such as coffee, juice, or mineral water, may reduce nicotine absorption in the mouth. To achieve maximum nicotine absorption, avoid consuming these beverages for 15 minutes before using the gum.

Adults and elderly patients

Use of Nicorette® Wintergreen chewing gum as monotherapy

Each Nicorette® Wintergreen chewing gum tablet should be slowly chewed for approximately 30 minutes, with pauses. Chew the gum until a strong taste of nicotine or a moderate tingling sensation appears; then stop chewing, place the gum between the gums and cheek until the taste and tingling disappear, then slowly chew again and repeat the procedure.

Depending on the intensity of smoking dependence, chewing gum with different concentrations of active substance may be used. For mild dependence, use 2 mg chewing gum. For heavy smokers (Fagerström nicotine dependence test ≥ 6 points, or those who smoke more than 20 cigarettes per day, or who smoke their first cigarette within 30 minutes after waking up), or for patients who cannot quit smoking using Nicorette® Wintergreen 2 mg chewing gum, it is recommended to start treatment with the 4 mg dosage form.

At the beginning of treatment, one tablet every two hours may be used. Usually, 8–12 chewing gums per day are sufficient. Do not use more than 24 tablets per day (for the 4 mg dosage) or more than 30 tablets per day (for the 2 mg dosage).

Complete smoking cessation

The duration of therapy should be individually determined. In case of complete smoking cessation, use Nicorette® for at least 3 months. Then gradually reduce the number of chewing gums used. Discontinue the treatment when daily consumption decreases to 1–2 tablets.

Regular use of Nicorette® Wintergreen chewing gum for more than 12 months is not recommended, although some former smokers may require longer treatment to prevent relapse. Keep several chewing gums on hand for unexpected cravings.

Psychological counseling and support usually help achieve success.

Smoking reduction

If smoking cessation is achieved gradually by reducing the number of cigarettes smoked, chew the gum between smoking episodes as soon as an irresistible craving occurs, in order to extend the intervals between smoking episodes and thereby reduce daily cigarette consumption. If reduction in the number of smoked cigarettes is not achieved within 6 weeks, reassess the therapeutic approach.

An attempt to quit smoking should be made when the patient feels ready, but no later than 6 months after starting treatment. If significant smoking cessation is not achieved within 9 months of starting treatment, reassess the treatment regimen.

Psychological counseling and support usually help achieve success.

Temporary abstinence

To prevent symptoms of temporary abstinence, it is recommended to use Nicorette® chewing gum during periods when the patient does not smoke, for example, in smoke-free zones or in other situations when the patient is unable to smoke and experiences sudden cravings.

Use of Nicorette® Wintergreen chewing gum 2 mg in combination with Nicorette® transdermal patch

Patients who still experience smoking cravings despite using nicotine-containing medications, or who have not succeeded with Nicorette® chewing gum alone, may use the Nicorette® transdermal patch together with Nicorette® Wintergreen chewing gum to rapidly relieve acute cravings.

Initial combination therapy

Treatment should begin with one 25 mg/16 hours patch per day in combination with Nicorette® Wintergreen 2 mg chewing gum. Use at least 4 chewing gums (2 mg) per day. In most cases, 5–6 tablets per day are sufficient. Do not use more than 24 tablets per day. The usual duration of treatment is 6–12 weeks. Then gradually reduce the nicotine dose.

Apply the patch in the morning and remove it before bedtime. Apply the patch to a dry, clean, hairless, and undamaged area of skin on the torso, arms, or thighs.

To minimize the risk of local irritation, apply the Nicorette® transdermal patch to different skin areas alternately.

After applying the patch, wash hands thoroughly to avoid eye irritation from residual nicotine on fingers.

Discontinuation of nicotine medications

Two regimens are possible (see table below):

Regimen with continued use of transdermal patch. Use a lower-strength patch, i.e., 15 mg/16 hours for 3–6 weeks, followed by a 10 mg/16 hours patch for another 3–6 weeks, in combination with the initial dose of Nicorette® Fresh Mint flavored 2 mg chewing gum. Then gradually reduce the number of chewing gums over 12 months.
Regimen without continued use of transdermal patch. Discontinue the patch and gradually reduce the number of chewing gum tablets over 12 months.

Table of recommended dosages:

Time period	Transdermal patch	2 mg chewing gum
First 6-12 weeks	1 patch with a strength of 25 mg/16 hours per day	As needed. Recommended: 5-6 pieces per day
Scheme 1. Discontinuation of nicotine-containing products followed by use of transdermal patch
Next 3-6 weeks	1 patch with a strength of 15 mg/16 hours per day	Continue using chewing gum as needed.
Further 3-6 weeks	1 patch with a strength of 10 mg/16 hours per day	Continue using chewing gum as needed.
Up to 12 months	----	Gradual reduction in the number of chewing gum pieces.
Scheme 2: Discontinuation of nicotine-containing products without further use of transdermal patch
Up to 12 months	----	Gradual reduction in the number of chewing gum pieces.

Children.

There is no experience with the use of Nicorette® in children. Nicotine chewing gum should not be used in individuals under 18 years of age without medical prescription.

Overdose.

Overdose may occur if the patient has very low tolerance to nicotine at the beginning of treatment or simultaneously receives nicotine from other sources (e.g., continued smoking). It is known that nicotine dependence, such as in smokers, leads to increased tolerance compared to non-smokers. The acute lethal dose of nicotine is 40–60 mg for children (in cases of tobacco ingestion from cigarettes into the oral cavity) and 0.8–1.0 mg/kg for non-smoking adults.

Excessive use of nicotine through chewing gum and/or smoking may lead to symptoms of overdose. The risk of poisoning from swallowing chewing gum is very low, as absorption is very slow and incomplete if the gum is not chewed.

Symptoms of overdose are the same as those observed in acute nicotine poisoning, namely: nausea, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disturbances, and pronounced general weakness. With high-dose exposure, in addition to the above symptoms, arterial hypotension, weak and irregular pulse, labored breathing, prostration, vascular collapse, and generalized seizures may occur.

Nicotine doses well tolerated by adult smokers during treatment may cause severe poisoning symptoms in young children, potentially leading to fatal outcomes.

Management in case of overdose

Nicotine intake should be stopped immediately, and symptomatic treatment should be initiated. Activated charcoal reduces nicotine absorption in the gastrointestinal tract.

Adverse reactions.

Possible consequences of smoking cessation: these include emotional and cognitive effects such as dysphoria or depressed mood, nocturnal awakenings, insomnia, irritability or aggression, frustration or anger, anxiety, restlessness, difficulty concentrating, and agitation. Physical effects of smoking cessation may also occur, such as decreased heart rate, increased appetite or weight gain, dizziness or pre-syncope symptoms, cough, constipation, bleeding gums or aphthous ulcers, or nasopharyngitis. In addition, clinically significant nicotine craving may lead to frequent urges to smoke.

Nicorette® Wintergreen Mint may cause adverse reactions similar to those caused by nicotine from other sources.

Excessive use of Nicorette® Wintergreen Mint chewing gum by non-smokers may lead to nausea, weakness, or headache. Excessive swallowing of dissolved nicotine may initially cause hiccups.

Nicotine contained in the chewing gum may occasionally cause mild throat irritation at the beginning of treatment; however, most patients adapt to this with continued use.

Increased salivation may occur during treatment.

Allergic reactions (including symptoms of anaphylactic shock) may rarely occur during use of Nicorette® Wintergreen Mint chewing gum.

Individuals prone to digestive problems may initially experience mild digestive discomfort or heartburn when using the 4 mg dose of Nicorette® Wintergreen Mint chewing gum. These symptoms usually resolve with slower chewing and switching to the 2 mg dose of Nicorette® Wintergreen Mint chewing gum (used more frequently if needed).

The likelihood and severity of adverse reactions depend on the dose.

Most adverse reactions occur within the first 3–4 weeks of starting treatment. Side effects of nicotine chewing gum are primarily due to incorrect chewing technique or dose-dependent pharmacological effects of nicotine.

Adverse events were reported with the following frequencies: very common ≥ 1/10; common ≥ 1/100, < 1/10; uncommon ≥ 1/1,000, < 1/100; rare ≥ 1/10,000, < 1/1,000; very rare < 1/10,000, frequency not known (cannot be estimated based on available data).

Psychiatric disorders: uncommon − sleep disturbances, including unusual dreams.

Nervous system disorders: common – dizziness, headache, burning sensation at application site; uncommon – paresthesia, oral paresthesia, oral hypoaesthesia, hot flushes, hyperhidrosis, fatigue, asthenia, malaise, eye disorders, dysphonia, dysgeusia; frequency not known – seizures*.

Cardiovascular disorders: uncommon – palpitations, tachycardia, hypertension, dyspnea, hot flushes; very rare – reversible atrial fibrillation.

Respiratory system disorders: very common – mouth or throat pain, throat irritation; common – cough; uncommon – bronchospasm, sneezing, chest pain and discomfort, nasal congestion, dyspnea, dysphonia, throat tightness, oropharyngeal pain.

Gastrointestinal disorders: common – increased salivation, discomfort, hiccups, nausea, vomiting, heartburn, digestive disturbances, abdominal pain, dry mouth sensation, flatulence, stomatitis, dyspepsia, diarrhea; uncommon – dysphagia, belching, urge to vomit, burning sensation, glossitis, blistering and desquamation of the oral mucosa, oral paresthesia; rare – oral hypoaesthesia, urge to vomit; frequency not known – dry throat sensation, gastrointestinal discomfort, lip pain.

Eye disorders: frequency not known – blurred vision, increased lacrimation.

Skin and subcutaneous tissue disorders: uncommon – erythema, urticaria, hyperhidrosis, skin rash, pruritus.

General disorders and administration site conditions: common – oral and pharyngeal mucosal ulcers, jaw muscle pain, fatigue; uncommon – chest discomfort and pain, asthenia, malaise; rare – allergic reactions, including angioedema, oral pain, dry mouth, throat tightness, glossitis, blistering of the oral mucosa, stomatitis; frequency not known – lip pain.

Immune system disorders: anaphylactic reactions, hypersensitivity reactions, including allergic reactions such as rash and pruritus.

Musculoskeletal and connective tissue disorders: uncommon – jaw pain; frequency not known – muscle tension.

Some symptoms such as dizziness, headache, irritability, aggression, dysphoria, depressed mood, restlessness, poor concentration, intolerance, increased appetite, weight gain, intense craving to smoke, decreased heart rate, and sleep disturbances may be manifestations of withdrawal syndrome caused by smoking cessation. The frequency of aphthous stomatitis may increase. The relationship of this symptom to the use of chewing gum has not been established.

The chewing gum may adhere to dental prostheses and bridges and, in rare cases, may damage them.

Adverse effects that may occur with combination therapy (chewing gum and transdermal patch) differ only by local adverse reactions related to the drug formulation. The frequency of adverse effects is provided in the instructions for medical use of the respective medicinal products.

*Seizures have been reported in patients receiving anticonvulsant therapy or with a history of epilepsy.

Reporting of adverse reactions

Reporting suspected adverse reactions after medicine authorization is of great importance. It allows continuous monitoring of the benefit-risk ratio of the medicine. Healthcare professionals and patients or their legal representatives should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store at temperatures not exceeding 25 °C in a place inaccessible to children.

Packaging. 15 chewing gums per blister; 2 blisters per cardboard package.

Category of supply. Over-the-counter.

Manufacturer.

McNeil AB, Sweden.

Manufacturer's address and location of operations.

Norrbroplatsen 2, Helsingborg, 25442, Sweden.

Marketing authorization holder.

McNeil AB, Sweden.

Address of marketing authorization holder.

Box 941, Helsingborg, 25109, Sweden.

Representative of the marketing authorization holder.

LLC "Johnson & Johnson Ukraine", Ukraine.

Address of the representative.

32/2, Knyaziv Ostrozkykh St., Kyiv, 01010, Ukraine.

In case of adverse reactions, please contact:

+38 (044) 498 0888

+38 (044) 498 7392