Nicorette with fresh mint flavor, medicinal chewing gum, 4 mg, blister, No. 30

Instructions for Nicorette with fresh mint flavor, medicinal chewing gum 4 mg, blister No. 30

Composition

active ingredient: nicotine;

1 medicinal chewing gum contains nicotine-polymer complex – 11.0 mg or 22.0 mg, which corresponds to nicotine 2 mg or 4 mg;

Excipients: core: chewing gum base, xylitol, peppermint oil, anhydrous sodium carbonate, sodium bicarbonate (only for 2 mg dosage), acesulfame potassium, levomenthol, light magnesium oxide, quinoline yellow (E 104) (only for 4 mg dosage); coating: xylitol, peppermint oil, acacia gum, titanium dioxide (E 171), carnauba wax, quinoline yellow (E 104) (only for 4 mg dosage).

Dosage form

Medicinal chewing gum.

Main physicochemical properties: square coated pads of white color (for 2 mg) or light yellow color (for 4 mg), approximately 15x15x6 mm in size, with a mint odor.

Pharmacotherapeutic group

A drug for the treatment of nicotine addiction.

ATX code N07B A01.

Pharmacological properties

Pharmacodynamics

Abrupt withdrawal from nicotine-containing products after a long period of daily use leads to a characteristic withdrawal syndrome: dysphoria or depression; insomnia; irritability; frustration or aggression; restlessness; impaired ability to concentrate; intolerance; cardiac disorders; increased appetite or weight gain. Nicotine dependence is also a pronounced clinical symptom observed in withdrawal syndrome.

Nicorette® with fresh mint flavor prevents the development of withdrawal syndrome in people who have quit smoking; helps avoid the development of nicotine addiction.

Nicorette® with fresh mint flavor, when used in the appropriate dose, helps control body weight after quitting smoking.

Pharmacokinetics

The amount of nicotine absorbed depends on the amount of nicotine released and lost during swallowing. During chewing, nicotine is slowly released and absorbed in the oral cavity. The systemic bioavailability of swallowed nicotine is negligible due to its utilization by the liver in the so-called “first-pass effect”. Rapid achievement of high nicotine concentrations, as observed with smoking, is unlikely with the use of Nicorette®.

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

The maximum concentration in the blood is reached after 30 minutes of chewing and at that time is similar to the concentration 20-30 minutes after smoking a medium-strength cigarette.

Indication

Treating tobacco addiction by reducing nicotine cravings and easing withdrawal symptoms; facilitating the process of quitting smoking if motivated; helping smokers who cannot completely give up nicotine addiction to reduce the number of cigarettes smoked.

Contraindication

Nicorette® with fresh mint flavor is contraindicated in:

hypersensitivity to nicotine or any of the components of the drug;

recent myocardial infarction (within the last 3 months);

unstable or progressive angina pectoris;

Prinzmetal's angina;

severe heart arrhythmias;

acute stroke.

Interaction with other medicinal products and other types of interactions

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

Plasma concentrations of some other drugs metabolized by CYP1A2 may also increase after smoking cessation; for example, this phenomenon may be observed for imipramine, olanzapine, clomipramine, and fluvoxamine, but the data supporting this effect are insufficient and the possible clinical consequences have not been investigated.

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, and may also enhance the pain response (angina-like chest pain) induced by adenosine.

Application features

Smokers who wear dentures may have difficulty chewing Nicorette® Fresh Mint. Chewing gum can stick to dentures and sometimes damage them.

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

Dependent smokers with a recent myocardial infarction (<4 weeks), unstable or progressive angina pectoris, including Prinzmetal's angina, severe cardiac arrhythmias, uncontrolled hypertension, or recent stroke should be encouraged to quit smoking without medical treatment (e.g., psychotherapy). If this does not help, Nicorette® Fresh Mint may be considered. As safety data in this patient group are limited, Nicorette® Fresh Mint should only be used under close medical supervision.

Nicorette® chewing gum with fresh mint flavor should be used with caution in patients with moderate or severe hepatic impairment and severe renal impairment, as the clearance of nicotine or its metabolites may be reduced, which increases the risk of side effects.

Nicotine may exacerbate symptoms in patients with esophagitis, gastric ulcers and peptic ulcers, therefore Nicorette® chewing gum with fresh mint flavour should be used with caution in this group of patients. Cases of ulcerative stomatitis have been reported.

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

For patients with diabetes, when they stop smoking and start nicotine replacement therapy, more careful monitoring of blood sugar levels than usual is recommended, as the reduction in nicotine-induced catecholamine release may affect carbohydrate metabolism.

Smoking cessation may require a reduction in insulin dose in patients with diabetes.

Some patients continue to use Nicorette® Fresh Mint beyond the recommended period, but the potential risk of long-term use of the gum is much lower than that of continued smoking.

Nicorette® chewing gum with fresh mint flavor contains xylitol, which may have a laxative effect.

Calorie content: 2.4 kcal/g xylitol, corresponding to 1.5 kcal and 1.4 kcal per pad (Nicorette® fresh mint 2 mg and 4 mg respectively).

The specifics of using the combination of Nicorette® chewing gum with fresh mint flavor and Nicorette® transdermal patch are the same as for each product separately (see the instructions for medical use for Nicorette® transdermal patch).

Convulsions: Caution should be exercised in patients taking anticonvulsant therapy or with a history of epilepsy, as cases of seizures have been reported in association with nicotine use.

Possibility of addiction. Addiction to nicotine products can occur. However, it is rare, less harmful to health than nicotine addiction from smoking, and easier to break.

Use during pregnancy or breastfeeding

Nicotine enters the fetus and affects its respiratory activity and blood circulation. The effect on blood circulation is dose-dependent. Smoking during pregnancy can cause a decrease in the body weight of the newborn, as well as increase the risk of miscarriage and perinatal death.

Quitting nicotine is the single most effective measure to improve the health of a pregnant smoker and her baby, and the sooner it happens, the better.

Pregnant women should be advised to quit smoking without the use of nicotine replacement therapy.

However, if a pregnant woman is unable to quit smoking without pharmacological support (or this is considered unlikely), nicotine replacement therapy may be used for this purpose, as the risk to the fetus is lower than that expected from tobacco smoking.

For nicotine replacement therapy in pregnant women, intermittent nicotine dosage forms should be preferred, given the possibility of decreasing nicotine levels with their use. However, in the presence of nausea and/or vomiting, the use of patches may be necessary, which, 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 child and should therefore be stopped. The risk to the fetus from using Nicorette® has not been fully studied. Continuing to smoke poses a greater risk to the fetus than using nicotine replacement therapy products.

Nicotine passes freely into breast milk in amounts that may have adverse effects on the infant, even when used in therapeutic doses, so patients should be advised to stop smoking without using nicotine replacement therapy. If this is not possible, the use of Nicorette® Fresh Mint, Chewing Gum, Medicinal, by breastfeeding women is possible only on the recommendation of a doctor after a careful assessment of the risk/benefit ratio. Nicotine should be avoided during breastfeeding. The relatively small amount of nicotine found in breast milk during nicotine replacement therapy is less dangerous for the infant than passive smoking. Nicotine dosage forms with intermittent administration can minimize the amount of nicotine in breast milk and allow breastfeeding when its level is lowest.

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

Smoking tobacco in women slows down the process of conception, which reduces the success of in vitro fertilization and significantly increases the risk of infertility.

In men, tobacco smoking reduces sperm production, increases oxidative stress, and damages DNA. Smokers' sperm have reduced ability to fertilize.

There is no reliable data on the effects of nicotine on the human body.

Impact on reproductive function

In contrast to the well-known adverse effects of tobacco smoking on human conception and pregnancy, the relevant effects of nicotine when used therapeutically are unknown. There are currently no specific recommendations regarding the need for female contraception in such cases. It is more appropriate for women trying to conceive to abstain from both smoking and nicotine replacement therapy. Although smoking may negatively affect male fertility, there is no evidence to support the need for male contraceptives during nicotine replacement therapy.

Ability to influence reaction speed when driving vehicles or other mechanisms

Caution should be exercised when driving, as sometimes the use of Nicorette® can cause dizziness.

Method of administration and doses

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

Chewing gum 4 mg is used as monotherapy.

Do not eat or drink with gum in your mouth. Beverages that lower the pH of your mouth, such as coffee, juice, or mineral water, may reduce the absorption of nicotine from your mouth. To maximize nicotine absorption, avoid consuming these beverages for 15 minutes before using the gum.

Adults and the elderly

Use of Nicorette® chewing gum with fresh mint flavor as monotherapy.

Each Nicorette® Fresh Mint Lozenge should be chewed slowly for approximately 30 minutes, with pauses. Nicorette® Fresh Mint Lozenge should be chewed until a strong nicotine taste or a moderate burning sensation is felt; then the chewing should be stopped, the gum placed between the gum and cheek until the nicotine taste and burning sensation disappear, then chewed slowly again and the procedure repeated.

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

At the beginning of treatment, you can use 1 pad every two hours. Usually, 8-12 chewing gums per day are sufficient. Do not use more than 24 pads per day (for the 4 mg dosage) or more than 30 pads per day (for the 2 mg dosage).

Complete cessation of smoking

The duration of therapy is determined individually. In the case of complete cessation of smoking, Nicorette® should be used for at least 3 months. Then the amount of chewing gum should be gradually reduced. The use of the drug should be discontinued when the daily consumption of gum decreases to 1-2 pads.

Regular use of Nicorette® Mint Gum for more than 12 months is not recommended, although some ex-smokers may need longer treatment to prevent relapse. Keep a spare pack of gum in case you feel the urge to smoke.

Psychological counseling and support usually help achieve success.

Reducing smoking

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

Regular use of Nicorette® Mint Gum for more than 12 months is not recommended, although some ex-smokers may need longer treatment to prevent relapse. Keep a spare pack of gum in case you feel the urge to smoke.

Psychological counseling and support usually help achieve success.

Temporary abstinence

To avoid temporary withdrawal symptoms, it is recommended to use Nicorette® gum during periods when the patient is not smoking, for example in areas where smoking is prohibited or in other situations where the patient is forced not to smoke and has a sudden desire to smoke.

Use of Nicorette® chewing gum with fresh mint flavor 2 mg in combination with Nicorette® transdermal patch

Individuals who experience cravings despite using nicotine-containing medications, or who have not been successful with Nicorette® chewing gum, can use Nicorette® transdermal patch together with Nicorette® chewing gum with fresh mint flavor for quick relief from cravings.

Initial combination treatment

Treatment should be initiated with one patch of 25 mg/16 hours per day in combination with Nicorette® 2 mg fresh mint gum. At least 4 pieces of gum (2 mg) should be used per day. In most cases, 5-6 lozenges per day are sufficient. Do not use more than 24 lozenges per day. The usual duration of treatment should be 6-12 weeks. The nicotine dose should then be gradually reduced.

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

To reduce the risk of local irritation, Nicorette® transdermal patch should be applied alternately to different areas of the skin.

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

Withdrawal from nicotine medications

Two schemes are possible (see table below).

1. Transdermal patch continuation regimen. 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 an initial dose of 2 mg Nicorette® Fresh Mint Gum. Then gradually reduce the number of patches over 12 months.

2. Scheme without further use of the transdermal patch. Discontinue use of the transdermal patch and gradually reduce the number of pads over 12 months.

Table of recommended doses:

Children

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

Overdose

Overdose may occur if the patient has a very low tolerance to nicotine at the beginning of treatment or is simultaneously receiving nicotine from other sources (e.g., long-term smoking). It is known that nicotine addiction, for example, in smokers, leads to the development of greater tolerance compared to non-smokers. The acute lethal dose of nicotine for children (in the case of inhalation of tobacco from cigarettes in the oral cavity) is 40-60 mg and from 0.8 to 1.0 mg/kg for non-smoking adults.

Excessive use of nicotine through chewing gum and/or smoking can cause signs of overdose. The risk of poisoning from swallowing chewing gum is very low because, if not chewed, absorption is very slow and incomplete.

Doses of nicotine that are well tolerated by adult smokers during treatment can cause serious symptoms of severe poisoning in young children, which can lead to fatal consequences.

Overdose measures

Nicotine intake should be stopped immediately and symptomatic treatment should be administered. Activated charcoal reduces the absorption of nicotine in the digestive tract.

Side effects

Possible effects of smoking cessation: These include emotional and cognitive effects, such as dysphoria or depressed mood, nighttime awakenings, insomnia, irritability or aggression, frustration or anger, anxiety, restlessness, difficulty concentrating, and agitation. There are also possible physical effects of smoking cessation, such as decreased heart rate, increased appetite or weight gain, dizziness or fainting symptoms, cough, constipation, bleeding gums or aphthous ulcers, or nasopharyngitis. In addition, clinically significant nicotine cravings may lead to frequent urges to smoke.

Nicorette® with fresh mint flavor may cause adverse reactions similar to reactions to nicotine from other sources.

Excessive use of Nicorette® Mint, Chewing Gum, or Medicinal by non-smokers may cause nausea, weakness, or headache. Excessive ingestion of dissolved nicotine may initially cause hiccups.

The nicotine in the gum can sometimes cause minor throat irritation at the beginning of treatment, but most patients adapt to this with continued use.

When using the drug, increased salivation is possible.

When using Nicorette® with fresh mint flavor, chewing gum, or medicated gum, allergic reactions (including symptoms of anaphylactic shock) may occasionally occur.

People with digestive problems may initially experience minor indigestion or heartburn when using Nicorette® Fresh Mint 4 mg. These symptoms usually disappear with slow chewing and use of Nicorette® Fresh Mint 2 mg (more often if necessary).

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

Most adverse reactions occur within 3-4 weeks of starting treatment. Side effects of nicotine gum occur mainly due to improper chewing or dose-dependent pharmacological effects of nicotine.

Adverse reactions occurred with the following frequency: 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 unknown (cannot be estimated from the available data).

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

Nervous system: often - dizziness, headache, burning sensation at the site of application; infrequently - paresthesia, oral paresthesia, oral hypoesthesia, hot flashes, hyperhidrosis, fatigue, asthenia, malaise, eye disorders, dysphonia, dysgeusia; frequency unknown - convulsions*.

From the cardiovascular system: infrequently - palpitations, tachycardia, hypertension, shortness of breath, hot flashes; very rarely - reversible atrial fibrillation.

On the part of the respiratory system: very often - pain in the mouth or throat, throat irritation, often - cough; infrequently - bronchospasm, sneezing, chest pain and discomfort, nasal congestion, shortness of breath, dysphonia, feeling of tightness in the throat, oropharyngeal pain.

On the part of the digestive tract: often - increased salivation, discomfort, hiccups, nausea, vomiting, heartburn, indigestion, abdominal pain, dry mouth, flatulence, increased salivation, stomatitis, dyspepsia, diarrhea; infrequently - dysphagia, belching, retching, burning sensation, glossitis, blistering and peeling of the oral mucosa, oral paresthesia; rare - oral hypoesthesia, retching; frequency unknown - dry throat, gastrointestinal discomfort, lip pain.

On the part of the organs of vision: frequency unknown - blurred vision, increased lacrimation.

Skin and subcutaneous tissue disorders: infrequently - erythema, urticaria, hyperhidrosis, skin rash, itching.

General disorders and administration site conditions: common: oral and throat mucosal ulcers, masticatory muscle pain, fatigue; uncommon: chest discomfort and pain, asthenia, malaise; rare: allergic reactions, including angioedema, oral pain, dry mouth, throat tightness, glossitis, oral mucosal blistering, stomatitis; frequency unknown: lip pain.

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

Musculoskeletal and connective tissue disorders: uncommon – jaw pain; frequency unknown – muscle tension.

Chewing gum can stick to the base of dentures and bridges and, in rare cases, damage them.

Side effects that may occur in the case of combined treatment (chewing gum and transdermal patch) differ only in local adverse reactions caused by the dosage form of the drug. The frequency of side effects is given in the instructions for medical use of the respective drugs.

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

Adverse reaction reporting

Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.

Expiration date

3 years.

Storage conditions

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging

15 chewing gums in a blister; 2 blisters in a cardboard box.

Vacation category

Without a prescription.

Producer

McNeil AB, Sweden.

Location of the manufacturer and address of its place of business.

Norrbroplatsen 2, Helsingborg, 25442, Sweden.

Applicant

McNeil AB, Sweden.

Location of the applicant.

Box 941, Helsingborg, 25109, Sweden.

Applicant's representative.

Johnson & Johnson Ukraine LLC, Ukraine.

Location of the applicant's representative.

01010, Kyiv, Knyaziv Ostrozkyh St., 32/2.

In case of adverse reactions, please contact the following numbers:

+38 (044) 498 0888

+38 (044) 498 7392