Nicorette translucent patch Plaster, sachet, 7 pcs, 10/16 mg/h

Nicorette translucent patch Plaster, sachet, 7 pcs, 10/16 mg/h

Directions for use and doses

Adults and elderly people: The patch is applied to an intact area of ​​skin immediately after waking up in the morning and removed before going to bed. Treatment with this drug simulates the fluctuations in nicotine concentrations throughout the day in a smoker; Moreover, during sleep, nicotine does not enter the body. The use of a transdermal patch during the day does not cause the disturbances observed when nicotine enters the body during sleep. Heavy smokers (more than 20 cigarettes per day) are recommended to start with stage 1 of therapy, using 1 patch of 25 mg/16 hours daily for 8 weeks. Then begin a gradual reduction in the dose of the drug: 1 patch of 15 mg/16 hours, daily, for 2 weeks, and then - 1 patch of 10 mg/16 hours, daily, for 2 weeks. Light smokers (10-20 cigarettes per day) are recommended to start therapy with stage 2 (15 mg) for 8 weeks, then reduce the dose to stage 3 (10 mg) for the final 4 weeks. In most cases, the use of a transdermal patch for more than 6 months is not recommended. However, some people may need longer therapy to avoid relapse into smoking. How to Apply the Transdermal Patch (Patient Information): The Nicorette patch should be applied to dry, clean, intact, hair-free skin such as the thighs, upper limbs, or chest. It is necessary to change the application site every day: do not use the same area for two consecutive days. 1. Before applying the patch, wash your hands thoroughly.2. Cut the plaster package with scissors along the edge as indicated on it. Select a clean, dry, hair-free area of ​​skin (such as the thigh, upper limb, or chest).3. Remove one half of the silver aluminized protective film without touching the adhesive surface of the patch.4. Strengthen the part of the patch freed from the protective film on the skin and remove the remaining half of the silver aluminized protective film.5. Press the patch firmly against the skin with your palm or fingertips.6. Run your finger along the edge of the patch, making sure it is firmly attached. In combination with chewing gum: The Nicorette patch can also be used in conjunction with Nicorette chewing gum at a dosage of 2 mg in situations where, while using the patch, a person continues to periodically experience an irresistible urge to smoke, or if it was not possible to quit smoking using only chewing gum or just a patch. In combination with the Nicorette patch, Nicorette chewing gum with a dosage of 2 mg allows you to quickly relieve strong urges to smoke when necessary. Initial therapy: Treatment should begin with a 25 mg/16 hour patch (stage 1) in combination with 2 mg chewing gum. In this case, use at least 4 chewing gums (2 mg dosage) per day; usually 5-6 chewing gums are enough. The number of chewing gums should not exceed 15 pieces/day. Usually the general course of treatment lasts for 8 weeks. After this, the dose of nicotine should be reduced gradually. The patch is applied immediately after waking up in the morning and removed before going to bed. The Nicorette patch should be applied to dry, clean, intact, hair-free skin, such as the thighs, upper limbs, or chest. It is necessary to change the application site every day: do not use the same area for two consecutive days. After applying the patch, you should wash your hands thoroughly to avoid eye irritation from possible nicotine contact. Withdrawal of combination therapy: There are two ways to discontinue combination therapy. Method 1: Over the next 2 weeks, switch from the 25 mg/16 hour patch (Stage 1) to the 15 mg/16 hour patch (Stage 2), and then over the next 2 weeks to the 10 mg/16 hour patch (Stage 3). ), while maintaining the amount of chewing gum used at a dosage of 2 mg, as in initial therapy. Next, the amount of chewing gum is gradually reduced until complete abolition for the time that a person needs depending on his needs, but no later than 12 months after the start of combination therapy. Method 2: consists of completely canceling the patch immediately after the end of the initial therapy phase. Next, the amount of chewing gum is gradually reduced at a dosage of 2 mg until complete discontinuation for the time that a person needs depending on his needs, but no later than 12 months after the start of combination therapy.

Nicorette chewing gum 2 mg No. 15x2

Name

Nicorette.

Release forms

Chewing gum.

INN

Nicotine.

FTG

A treatment for nicotine addiction.

Compound

Active ingredient: nicotine-polymer complex 20% - 10 mg (corresponds to 2 mg of nicotine) Excipients: chewing gum base*, sorbitol (E420), liquid sorbitol (crystallizing), anhydrous sodium carbonate, sodium bicarbonate, flavor additive for smokers 84.6422, flavor additive Haverstroo ZD 49284, glycerin 85%. * Chewing gum base is a mixture of different types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%).

Description

Square beige pads with a characteristic odor and size approximately 14 × 14 × 5 mm.

Pharmacotherapeutic group

Medicines used for nicotine addiction. ATX code: N07BA01.

Pharmacological properties

Pharmacodynamics After abrupt cessation of smoking in patients who have annually used tobacco-containing products for a long time, withdrawal syndrome may develop, which includes: dysphoria, insomnia, increased irritability, anxiety, impaired concentration, decreased heart rate, increased appetite or in weight. An important symptom of withdrawal syndrome is the desire to smoke. In the treatment of tobacco addiction, nicotine replacement therapy reduces the need for the number of cigarettes smoked, reduces the severity of withdrawal symptoms that occur with complete cessation of smoking in those who decide to quit smoking, facilitates temporary abstinence from smoking, and also helps reduce the number of cigarettes smoked in those who cannot or does not want to completely quit smoking. Pharmacokinetics Nicotine coming from chewing gum is quickly absorbed through the mucous membrane of the cheek and is detected in the blood after 5-7 minutes. The maximum concentration of nicotine is reached 30 minutes after the start of chewing. The volume of distribution of nicotine when administered intravenously is 2-3 l/kg, and the half-life is approximately 2 hours. Nicotine is primarily eliminated by the liver, with an average plasma clearance of about 70 L/hour. Nicotine is also metabolized in the kidneys and lungs. More than 20 nicotine metabolites have been identified that are inferior to it in activity. The binding of nicotine to plasma proteins is less than 5%. In this regard, disturbances in nicotine binding during concomitant use of other drugs or changes in plasma protein levels in various diseases should not have a significant effect on nicotine kinetics. The main metabolite of nicotine in plasma, cotinine, has a half-life of 15-20 hours, and its concentration is 10 times higher than that of nicotine. Mainly cotinine (15% of the dose) and trans-3-hydroxy-cotinine (45% of the dose) are excreted in the urine. From 10% to 30% of the nicotine dose is excreted unchanged in the urine. The progressive deterioration of renal function is accompanied by a decrease in the overall clearance of nicotine. Its pharmacokinetics does not change in patients with liver cirrhosis with mild liver dysfunction (Child-Pugh index 5) and decreases in patients with liver cirrhosis with moderate liver dysfunction (Child-Pugh index 7). In smokers treated with hemodialysis, an increase in plasma nicotine concentrations was noted. In elderly patients, there is a slight decrease in the total clearance of nicotine, which does not require dose adjustment.

Indications for use

Treatment of tobacco addiction by reducing the need for nicotine in the following cases: - reducing withdrawal symptoms that occur with complete cessation of smoking in patients who decide to quit smoking; - with temporary cessation of smoking; - reducing the number of cigarettes smoked by those who cannot or do not want to completely quit smoking.

Contraindications

Hypersensitivity to nicotine or other components of chewing gum. Age up to 12 years. Use in non-smokers.

Pregnancy and lactation

Nicotine crosses the placenta and is excreted in breast milk, and therefore its use may pose a danger to the fetus or child. Patients should be informed of the need to attempt to quit smoking without nicotine replacement therapy. If such attempts are unsuccessful, the decision to carry out therapy is made after comparing the possible positive effect and potential harm. Nicotine passes into breast milk in small quantities even when taken in therapeutic doses, which can negatively affect the baby’s health when the drug is taken by a nursing mother. In order to reduce the negative effects of nicotine on a child, Nicorette® chewing gum should be used immediately after feeding. The use of Nicorette® chewing gum during pregnancy and breastfeeding is possible only after consultation with a doctor, after assessing the ratio of the expected benefit and risk to the fetus or child.

Directions for use and doses

Adults and elderly people The dosage is selected individually depending on the intensity of smoking. As a rule: - Nicorette® chewing gum at a dosage of 2 mg should be used when smoking less than 20 cigarettes a day or when smoking the first cigarette 30 minutes after waking up; How to use Nicorette® chewing gum Nicorette® chewing gum should be used in all cases when an irresistible urge to smoke occurs, in accordance with the following scheme: Chew the gum slowly, for approximately 30 minutes, until a strong taste or mild feeling appears. burning sensation, stop chewing and leave the gum between the inside of the cheek and the gum; after the taste and/or burning sensation disappears, slow chewing should be resumed. Complete smoking cessation You should chew only one pad at a time when you stop smoking. When completely quitting smoking, the dose of chewing gum per day is determined by the degree of dependence on nicotine, but is usually 8-12 pieces per day and should not exceed 15 pieces per day. Chewing gum should be used at the indicated dose for at least 3 months, after which the number of gums used daily should be gradually reduced until completely discontinued. The gum is discontinued when the daily dose is 1 - 2 pieces per day. Regular use of chewing gum for more than 12 months is usually not recommended, but some people require longer therapy to avoid relapse into smoking. Reducing the number of cigarettes smoked Chewing gum should be used between smoking episodes to lengthen the intervals between smoking cigarettes in order to minimize cigarette consumption. If within 6 weeks it is not possible to reduce your daily cigarette consumption, you should seek help from a specialist. An attempt to quit smoking should be made as soon as you feel ready, but no later than 6 months after starting therapy. If you have not been able to make a serious attempt to quit smoking within 9 months of starting therapy, you should consult a specialist. Regular use of chewing gum for more than 12 months is usually not recommended, however, some people require longer therapy to avoid relapse or return to their previous level of tobacco use. The simultaneous provision of medical counseling and psychological support usually increases the effectiveness of therapy. Temporary Smoking Quit Chewing gum can be used during periods when you need to abstain from smoking, such as when you are in a smoke-free area or in other situations when you need to abstain from smoking. Under the age of 18, chewing gum can only be used on the recommendation of a doctor! Do not exceed the indicated dose! It is recommended to carry Nicorette® chewing gum with you so that you can use it when the urge to smoke arises.

Side effect

With a sharp cessation of smoking, emotional and cognitive effects may occur (dysphoria and depression, insomnia, irritability, frustration or anger, anxiety, difficulty concentrating, agitation or impatience, sleep disturbance, attacks of euphoria or depressed mood, irritability, decreased concentration) and physical effects (dizziness, headache, fainting symptoms, decreased heart rate, increased appetite and weight gain, cough, constipation, bleeding gums or canker sores, nasopharyngitis). At the beginning of treatment, the nicotine contained in chewing gum can sometimes cause mild irritation of the mucous membrane of the mouth and pharynx and increased salivation. If excessive amounts of dissolved nicotine are ingested at the beginning of treatment, hiccups may occur. Excessive use of Nicorette® Chewable Gum by individuals who do not smoke smoke may result in nausea, weakness, or headaches (similar to symptoms experienced by smoke smokers). Most adverse effects are dose-related and occur within the first 3-4 weeks. Some side effects are usually associated with the wrong way of using chewing gum. This problem usually resolves by chewing gum more slowly or using gum containing 2 mg nicotine (at shorter intervals if necessary). Frequency of occurrence of undesirable side reactions: very often (≥ 1/10), often (≥ 1/100 - frequency unknown - pain in the masticatory muscles. Gastrointestinal tract disorders: - very often - nausea - often - vomiting, abdominal pain , flatulence, dyspepsia, dry mouth, stomatitis, increased salivation, diarrhea - uncommon - belching, glossitis, aphthous ulcers or dryness of the oral mucosa, paresthesia of the oral mucosa, blistering of the oral mucosa and detachment of the mucous membrane - rare - dysphagia , oral hypoesthesia, retching - frequency unknown - dryness of the laryngeal mucosa, discomfort in the gastrointestinal tract, pain on the lips General disorders and disorders at the injection site: - often - burning, feeling of fatigue - infrequently - asthenia, discomfort and chest pain, malaise If any of the listed symptoms or other reactions not listed in these instructions appear, you should consult a doctor.

Overdose

Excessive intake of nicotine from replacement therapy and/or smoking may cause overdose symptoms. Symptoms of overdose are similar to those of acute nicotine poisoning and include nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing loss and severe weakness. When using high doses of nicotine, the following may occur: arterial hypotension, weak and irregular pulse, difficulty breathing, prostration, vascular insufficiency, circulatory collapse and generalized convulsions. Nicotine in doses tolerated by adult smokers can cause severe symptoms of intoxication, including death, in young children. Suspected nicotine poisoning in a child should be considered an emergency and treatment should be provided immediately. Treatment of overdose: nicotine use should be stopped immediately and symptomatic treatment should be prescribed. Activated carbon reduces the absorption of nicotine in the gastrointestinal tract. If necessary, artificial respiration and oxygen are prescribed.

Interaction with other drugs

Smoking (but not nicotine) causes an increase in the activity of the CYP1A2 enzyme. After smoking cessation, a decrease in the clearance of substrates of this enzyme may be observed. This may result in increased plasma levels of some drugs that are metabolized by this enzyme, which has potential clinical implications when using drugs with a low therapeutic breadth such as theophylline, tacrine, clozapine and ropinirole. Plasma levels of other drugs metabolized by CYP1A2, such as imipramine, olanzapine, clomipramine and fluvoxamine, may also increase after smoking cessation. However, there is no data to support this fact and the clinical effects of these drugs are unknown. Limited data suggest that smoking may induce the metabolism of flecainide and pentazocine. Clinically significant interactions with other drugs have not been established. However, there is an assumption that nicotine may increase the hemodynamic effect of adenosine, which can manifest itself in increased blood pressure, tachycardia and chest pain.

Precautionary measures

The benefits of quitting smoking outweigh any risks associated with the proper use of nicotine-containing medications. Nicorette® chewing gum should be used only after consulting a doctor. The risks and benefits should be assessed for patients suffering from the following diseases: - Cardiovascular disease: patients with a recent myocardial infarction or stroke, unstable or progressive angina, including Prinzmetal angina, severe arrhythmia, uncontrolled hypertension, cerebrovascular disorders, severe disorders heart rate, recent acute cerebrovascular accident, or after bypass surgery or angioplasty, patients with uncontrolled arterial hypertension should first of all be advised to quit smoking. If this fails, treatment with Nicorette® should be carried out under strict medical supervision. — Diabetes mellitus: Nicotine entering the human body during replacement therapy or smoking causes the release of catecholamines from the adrenal medulla. In this regard, Nicorette® chewing gum should be used with caution in patients with diabetes mellitus. - Renal and hepatic insufficiency: should be prescribed with caution to patients with moderate or severe liver dysfunction, severe renal failure. In these patients, the clearance of nicotine and its metabolites may be reduced, which in turn may lead to an increased risk of side effects. — Pheochromocytoma and uncontrolled hyperthyroidism: nicotine entering the human body through replacement therapy or smoking causes the release of catecholamines from the adrenal medulla. In this regard, Nicorette® chewing gum should be used with caution in patients with pheochromocytoma and uncontrolled hyperthyroidism. — Diseases of the gastrointestinal tract: it is necessary to prescribe with caution to patients suffering from esophagitis, gastric and duodenal ulcers, as when using Nicorette® chewing gum, an exacerbation of these diseases is possible. — The use of Nicorette® chewing gum in patients wearing dentures can be complicated by the fact that the chewing gum can stick to the denture and, in rare cases, even damage it. — Danger for children: doses of nicotine tolerated by adult patients can cause acute poisoning in children, including death. Therefore, nicotine-containing medications should be stored out of the reach of children. — Smoking cessation: polycyclic aromatic hydrocarbons found in tobacco smoke increase the activity of the CYP 1A2 enzyme (possibly also CYP 1A1), which can lead to an increase in the plasma concentration of a number of drugs that are metabolized by these enzymes (see section “Interactions”) with other drugs"). The use of Nicorette® chewing gum is associated with less risk than smoking.

Impact on the ability to drive vehicles and potentially dangerous mechanisms

No negative effect on the ability to drive a car or operate machinery has been established.

Package

15 chewing gums in a blister made of PVC/PVDC/aluminium. 1 or 2 blisters along with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of the reach of children.

Best before date

2.5 years. Note The expiration date marking (the period from the date of manufacture to the date specified in the “Best before” paragraph) may be less than 2.5 years by 1 month. Do not use the drug after the expiration date indicated on the package.

Conditions for dispensing from pharmacies

Dispensed from pharmacies without a prescription.

Buy Nicorette chewing gum. 2 mg in blister pack No. 15x2 in the pharmacy

Price for Nicorette chewing gum. 2 mg in blister pack No. 15x2

Instructions for use for Nicorette chewing gum. 2 mg in blister pack No. 15x2

Using the Nicorette patch for ulcerative colitis

There is evidence that the nicotine contained in Nicorette patches can help in the treatment of a complex and extremely unpleasant disease - ulcerative colitis, or chronic intestinal inflammation.

This occurs due to the anti-inflammatory properties of nicotine, which improves intestinal motility and stimulates the formation of a fairly dense and effective protective layer of mucus. It has also been confirmed that nicotine is a provitamin, which in the human body can be converted into vitamin B3, which is important for health and normal functioning, also called “vitamin PP”. Nicotinamide or nicotinic acid is the only vitamin in existence that is recognized by official modern medicine as a self-administered medicine. Conclusions that made it possible to link the positive effect of nicotine on the condition of patients with ulcerative colitis were made using a statistical method.

Doctors noticed that in smoking patients the number of cases of ulcerative colitis is much less than in people who have never used tobacco in any form. At the same time, when previously ill people quit smoking, relapses and exacerbations of the disease are observed, and the number of cases of colitis increases sharply.

Since the remaining components of tobacco are carcinogens or toxic products, it was concluded that nicotine is a limiting factor in the development of ulcerative colitis. The content of pure nicotine in the Nicorette patch is sufficient to reduce and even completely eliminate the signs of this extremely unpleasant disease.

Where to apply the Nicorette patch

Nicorette is almost transparent, its outer part is flesh-colored, it is small in size and almost invisible on the skin. Its use will not be made public unless you choose to talk about it.

You can attach the patch almost anywhere, but most often it is done on the upper arms. This makes it much easier to control, remove and stick on; usually these parts of the body are covered with sleeves.

But if desired, the patch can be used on any part of the body, you just need to avoid contact with mucous membranes and wash your hands thoroughly after using the product. Apply the product only to clean, dry, intact and non-inflamed skin, as hair-free as possible.

Side effects of using Nicorette

There are a number of contraindications to the use of the drug:

1. High sensitivity to nicotine or patch components.
2. History of myocardial infarction.
3. The presence of some forms of angina.
4. Arrhythmia in severe forms.
5. Stroke.
6. Chronic skin diseases.
7. The presence of damage or inflammation of the skin at the site of application of the product.

In addition to obvious contraindications, the following side effects may be detected during use of the product:

1. Some users (about 20% of all who used the patch) experienced minor skin irritations at first after starting to use the product, which went away after the body got used to it.
2. Dizziness and headache.
3. Urticaria or local inflammation of the skin, itching.
4. Drowsiness, lethargy, apathy.
5. Overexcitement, increased irritability, nervousness.
6. Palpitations, arrhythmia, shortness of breath, feeling of tightness in the chest.
7. Indigestion, discomfort, diarrhea or constipation, flatulence.
8. Increased appetite and associated weight gain.
9. Cough, dry mouth, changes in taste.
10. The appearance of aphthous ulcers on the mucous membranes of the mouth.
11. Muscle and joint pain, trembling limbs, back pain.
12. Sleep problems, insomnia.
13. Attention disorders.
14. Vision disorders.

In most cases, these problems arise at the very beginning of using nicotine patches and most often they are associated precisely with the dosage of the product used. Sometimes quick elimination of side effects can be achieved by simply changing the patch to another one containing less nicotine. If unpleasant symptoms do not disappear, and even more so if they intensify, the use of the drug will have to be discontinued. The doctor will be able to choose another remedy that does not cause such side effects. It should be noted that most of the above adverse reactions are extremely rare and are not always clearly and noticeably expressed, therefore, in the vast majority of cases, the Nicorette patch is well tolerated and does not provoke any negative effects, or they do not cause much concern to the person.

Which is better - Nicorette patch or spray?

The use of the Nicorette smoking cessation patch is convenient because nicotine enters the bloodstream slowly but constantly. This product is perfect for those people who are used to smoking a lot and quite often during the day.

Thanks to its form, Nicorette spray almost instantly suppresses the acute, sometimes unbearable desire to smoke. That is why it will be a very good helper for those people who suffer from the desire to smoke after stress, for example, during troubles at work, but in ordinary life they smoke moderately or lightly. The spray quickly stops the craving for smoking, and the patch develops the habit of doing without cigarettes.

How does the Nicorette patch work?

Those who have tried to quit smoking on their own are very familiar with the unpleasant withdrawal symptoms.

The Nicorette patch contains therapeutic concentrations of nicotine that help you get through withdrawal periods much easier and faster. If it is not used, the person will be tormented by the following phenomena:

• irritability, anxiety;
• memory impairment;
• low labor productivity, decreased concentration and thinking abilities;
• Bad mood;
• change in heart rate;
• "jumps" in pressure;
• insomnia.

Using the patch gently alleviates these symptoms. The nicotine from the patch is absorbed by the skin and enters the bloodstream. Its quantity is not enough to poison the body, but it is quite enough to eliminate the signs of smoking withdrawal.

Nicorette®

Adults and elderly people

The patch is applied to an intact area of ​​skin immediately after waking up in the morning and removed before going to bed. Treatment with this drug simulates the fluctuations in nicotine concentrations throughout the day in a smoker; Moreover, during sleep, nicotine does not enter the body. The use of a transdermal patch during the day does not cause the disturbances observed when nicotine enters the body during sleep.

Heavy smokers (more than 20 cigarettes per day)

It is recommended to start with stage 1 of therapy, using 1 patch of 25 mg/16 hours, daily, for 8 weeks. Then begin a gradual reduction in the dose of the drug: 1 patch of 15 mg/16 hours, daily, for 2 weeks, and then - 1 patch of 10 mg/16 hours, daily, for 2 weeks.

Non-heavy smokers (10-20 cigarettes per day)

It is recommended to start therapy with stage 2 (15 mg) for 8 weeks, then reduce the dose to stage 3 (10 mg) for the final 4 weeks.

In most cases, use of the transdermal patch for more than 6 months is not recommended. However, some people may need longer therapy to avoid relapse into smoking.

How to apply a transdermal patch (patient information)

The Nicorette® patch should be applied to dry, clean, intact, hair-free skin, such as the thighs, upper limbs or chest. It is necessary to change the application site every day: do not use the same area for two consecutive days.

1. Wash your hands thoroughly before applying the patch.

2. Use scissors to cut the patch package along the edge as indicated on the package. Select a clean, dry, hair-free area of ​​skin (such as the thigh, upper limb, or chest).

3. Remove one half of the silver aluminized protective film without touching the adhesive surface of the patch.

4. Fasten the part of the patch freed from the protective film to the skin and remove the remaining half of the silver aluminized protective film.

5. Press the patch firmly against the skin with your palm or fingertips.

6. Run your finger along the edge of the patch, making sure it is firmly attached.

Please note that only a new patch should be applied the next day.