Instructions for Nicorette Winter Mint Chewing Gum 2 mg blister No. 30
Composition
active ingredient: nicotine;
1 medicinal chewing gum contains nicotine-polymer complex – 11.0 mg, which corresponds to 2 mg of nicotine;
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); 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 for 4 mg dosage).
Dosage form
Medicinal chewing gum.
Main physicochemical properties: square pads with a white coating (for 2 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 Winter Mint prevents the development of withdrawal syndrome in people who have quit smoking; helps avoid the development of nicotine addiction.
Nicorette Winter Mint, when used in the appropriate dose, helps control body weight after quitting smoking.
Nicorette Winter Mint chewing gum contains excipients that have the properties to remove dental plaque. Clinical data has shown that Nicorette Winter Mint chewing gum has a whitening effect.
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.
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 Winter Mint 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 cardiac 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 Winter Mint. The gum can stick to dentures and sometimes damage them.
Nicorette Winter Mint chewing gum should be used with caution in patients with severe cardiovascular diseases: peripheral arterial occlusive disease, cerebrovascular disease, decompensated heart failure, stable angina, vasospasm, uncontrolled hypertension.
Dependent smokers with a recent myocardial infarction (<4 weeks), unstable or progressive angina, 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 Winter Mint can be considered. As safety data in this patient group are limited, Nicorette Winter Mint should only be used under close medical supervision.
Nicorette Winter Mint chewing gum should be used with caution in patients with moderate or severe hepatic impairment, 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 Winter Mint chewing gum 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 Winter Mint chewing 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 Winter 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 Winter Mint chewing gum contains xylitol, which may have a laxative effect.
Calorie content: 2.4 kcal/g xylitol, which corresponds to 1.5 kcal and 1.4 kcal per pad (Nicorette Winter Mint 2 mg and 4 mg respectively).
The specifics of using the combination of Nicorette Winter Mint chewing gum and Nicorette transdermal patch are the same as for each product separately (see the instructions for medical use for Nicorette transdermal patch).
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.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when driving vehicles, as sometimes the use of Nicorette can cause dizziness.
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 mortality.
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.
During pregnancy, Nicorette chewing gum can only be used in cases of very high levels of nicotine addiction and only on the recommendation of a doctor.
Nicotine should be avoided during breastfeeding. The relatively small amount of nicotine found in breast milk from nicotine replacement therapy is less harmful to the infant than passive smoking. Nicotine patches taken intermittently can minimize the amount of nicotine in breast milk and allow breastfeeding when levels are lowest.
The drug should be taken as soon as possible after breastfeeding.
Tobacco smoking 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.
Method of administration and doses
The 2 mg chewing gum can be used as monotherapy or in combination with the 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 Winter Mint chewing gum as monotherapy.
Each Nicorette Winter Mint lozenge should be chewed slowly for approximately 30 minutes, with pauses. Nicorette Winter Mint 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 to smoking, chewing gum with different concentrations of the active substance can be used. For mild addiction, use chewing gum 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 daily cigarette within 30 minutes of waking up) or patients who cannot quit smoking with Nicorette Winter Mint 2 mg chewing gum, 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 Winter 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
If smoking cessation is achieved gradually by reducing the number of cigarettes smoked, the gum should be chewed between smoking episodes as soon as the irresistible desire to smoke appears, in order to increase the intervals between smoking episodes as much as possible and thus reduce daily cigarette consumption. If a reduction in the number of cigarettes smoked is not achieved within 6 weeks, therapeutic measures should be reviewed.
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 Winter 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
Use of Nicorette Winter Mint 2 mg chewing gum in combination with Nicorette transdermal patch
Individuals who experience cravings despite using nicotine-containing medications, or who have not had success with Nicorette gum, can use Nicorette transdermal patch together with Nicorette Winter Mint chewing gum to quickly relieve cravings.
Initial combination treatment
Treatment should be initiated with one patch of 25 mg/16 hours per day in combination with Nicorette Winter Mint 2 mg chewing gum. At least 4 chewing gums (2 mg) should be used per day. In most cases, 5-6 pads per day are sufficient. No more than 24 pads per day should be used. 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).
Scheme with continued use of transdermal patch. Apply 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 mint-flavored chewing gum. Then gradually reduce the number of pads over 12 months. Scheme without continued use of transdermal patch. Discontinue use of patch and gradually reduce the number of pads over 12 months.
Table of recommended doses:
| Time | Plaster | Chewing gum 2 mg |
| The first 6-12 weeks | 1 patch with a strength of 25 mg/16 hours per day | As needed. Recommended 5-6 pads per day |
| Scheme 1. Withdrawal of nicotine-containing drugs with subsequent use of the transdermal patch | | |
| Next 3-6 weeks | 1 patch with a strength of 15 mg/16 hours per day | Continue to use chewing gum if necessary. |
| Next 3-6 weeks | 1 patch with a strength of 10 mg/16 hours per day | Continue to use chewing gum if necessary. |
| Up to 12 months | | Gradual reduction in the number of pads. |
| Scheme 2: Withdrawal from nicotine-containing medications without further use of the transdermal patch | | |
| Up to 12 months | | Gradual reduction in the number of pads. |
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 that in 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.
In case of overdose, the same symptoms are observed as in acute nicotine poisoning, namely: nausea, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing impairment and severe general weakness. When high doses enter the body, in addition to the above symptoms, arterial hypotension, weak and irregular pulse, difficulty breathing, prostration, vascular collapse and generalized convulsions may occur.
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.
Adverse reactions
Nicorette Winter Mint may cause side effects that are similar to those caused by nicotine from other sources.
Excessive use of Nicorette Winter Mint, chewing gum, medicated by non-smokers may result in 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 the drug Nicorette Winter Mint, chewing gum, medicated, allergic reactions (including symptoms of anaphylactic shock) may occasionally occur.
People with digestive problems may initially experience minor indigestion or heartburn when using Nicorette Winter Mint 4 mg. These symptoms usually disappear with slow chewing and use of Nicorette Winter 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 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 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.
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, stomatitis, dyspepsia, diarrhea, infrequently - dysphagia, belching, retching, burning sensation, glossitis, blistering and peeling of the oral mucosa, oral paresthesia, rarely - 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: infrequently - jaw pain, frequency unknown - muscle tension.
Some of the symptoms such as dizziness, headache, irritability, aggression, dysphoria, depressed mood, restlessness, poor concentration, intolerance, increased appetite, weight gain, cravings, decreased heart rate and sleep disturbances may be manifestations of withdrawal syndrome caused by quitting smoking. The incidence of aphthous stomatitis may increase. The relationship of this symptom to the use of chewing gum has not been proven.
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.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
15 chewing gums in a blister, 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
McNeil AB.
Location of the manufacturer and its business address
Norrbroplatsen 2, Helsingborg, 25109, Sweden.
