Nicorette transdermal patch 1 stage 25mg, No. 7

For the treatment of tobacco dependence by reducing the need for nicotine, the removal of withdrawal symptoms that occur when smoking cessation in patients with appropriate motivation.

Treatment with a transdermal NicoretteЃ patch simulates fluctuations in the concentration of nicotine during the day in a smoker; however, during sleep, nicotine does not enter the body. The use of a transdermal nicotine patch during the day does not cause the disturbances observed when nicotine enters the body during sleep.
NicoretteЃ transdermal patch can be used as monotherapy or in combination with NicoretteЃ chewing gum 2 mg, NicoretteЃ sublingual tablets 2 mg or NicoretteЃ topical spray 1 mg / dose.
If symptoms of an overdose appear (see the 'Overdose' section), the drug should be discontinued immediately.

Children and adolescents
There is no experience with the use of NicoretteЃ plaster by adolescents under the age of 18 years, therefore the drug should be used by persons under 18 years old strictly according to the doctor's prescription.

Adults
NicoretteЃ transdermal patch can be used in case of sudden smoking cessation, as well as to increase the intervals between smoking in order to reduce smoking as much as possible until completely smoking cessation.
The patient should do everything possible to permanently quit smoking while being treated with NicoretteЃ patch.
Patients with a high degree of dependence (more than 20 cigarettes per day) are recommended to start with stage 1 of therapy, using 1 patch 25 mg / 16 hours, daily, for 8 weeks.
Then a gradual decrease in the dose of the drug begins: 1 patch 15 mg / 16 hours, daily, for 2 weeks, and then - 1 patch 10 mg / 16 hours, daily, for the next 2 weeks.
Patients with a low degree of dependence (10Ц20 cigarettes per day) are recommended to start therapy with stage 2, using 1 patch 15 mg / 16 hours, daily, for 8 weeks. Then a gradual decrease in the dose of the drug begins to 3 stages: 1 patch 10 mg / 16 hours, daily, for the next 4 weeks.
How to apply a transdermal patch
The patch is applied to the intact skin immediately after waking up in the morning and removed at bedtime. The patch should be applied to dry, clean, undamaged skin that does not contain hair, such as the thigh, upper limb, or chest. It is necessary to change the place of overlap every day: do not use the same area for the next two days. After applying the patch, wash your hands thoroughly to avoid eye irritation from possible exposure to nicotine.
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. Choose a clean, dry area of ??skin that does not contain hair (such as thighs, upper limbs, or chest).
3. Remove one half of the silver aluminized protective film without touching the adhesive surface of the patch.
4. Attach the stripped portion of the patch 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 adhered.
7. If the patch comes off, put on a new one. Using a skin care oil or talcum powder may interfere with the patch's proper attachment.

In combination with chewing gums, sublingual tablets, topical spray
For smokers with a strong nicotine addiction (more than 20 cigarettes per day) or experiencing an irresistible urge to smoke, or smokers who have not been able to quit smoking using only one type of nicotine replacement therapy, the Nicorette patch can be used to quickly relieve the craving for smoking Ѓ in combination with chewing gums NicoretteЃ at a dosage of 2 mg / sublingual tablets NicoretteЃ at a dosage of 2 mg / spray for topical application NicoretteЃ at a dosage of 1 mg / dose.
The patch is applied to the intact skin immediately after waking up in the morning and removed at bedtime. The patch should be applied to dry, clean, undamaged skin that does not contain hair, such as the thigh, upper limb, or chest. It is necessary to change the place of overlap every day: do not use the same area for the next two days. After applying the patch, wash your hands thoroughly to avoid eye irritation from possible nicotine contamination.
Initial therapy:
Treatment should begin with a patch 25 mg / 16 hours (stage 1) in combination with chewing gums 2 mg / sublingual tablets 2 mg / spray for topical application 1 mg / dose. Usually 5-6 chewing gum / sublingual tablets per day or 13 topical spray doses per day are sufficient. The maximum daily dose for chewing gums is 15 pieces, for sublingual tablets - 24 pieces, for a topical spray - 32 doses.
Patients should completely stop smoking during therapy. Usually, the general course of treatment lasts for 8 weeks. Thereafter, the dose of nicotine should be gradually reduced.
Withdrawal of combination therapy: There
are two ways to cancel combination therapy .
Method 1: within the next 2 weeks, it is necessary to switch from a patch 25 mg / 16 hours (stage 1) to a patch 15 mg / 16 hours (stage 2), and then, over the next 2 weeks - to a patch 10 mg / 16 hours ( Stage 3), while maintaining, if necessary, the number of chewing gums / sublingual tablets / topical spray doses used, as with Initial Therapy. Further, the number of chewing gums / sublingual tablets / spray doses for topical application is gradually reduced until complete cancellation within the time required by the patient, depending on his needs, but no later than 12 months after the start of the combination therapy.
Method 2: consists in completely canceling the patch immediately after the end of the Initial therapy phase. Further, the number of chewing gums / sublingual tablets / spray doses for topical application is gradually reduced until complete cancellation within the time that the patient needs, depending on his needs, but no later than 12 months after the start of the combination therapy.

Nicotine base:
Dosage 10 mg / 16 h:
Nicotine base:
Active ingredient:
nicotine - 15.75 mg;
Excipients:
triglycerides (average chain length) - 18.27 mg, copolymer of basic butyl methacrylate - 14.58 mg, polyethylene terephthalate film 19 µm (on one side can be varnished) - carrier of the layer containing the active substance.
Acrylate base:
acrylic adhesive solution - 123.84 mg, potassium hydroxide - 0.70 mg, croscarmellose sodium - 5.00 mg, aluminum acetylacetonate - 0.06 mg, polyethylene terephthalate film 100 µm, aluminized on one side and siliconized on both sides - the carrier, performs the function of protecting the adhesive layer (removable backing), discarded before use.
Dosage 15 mg / 16 h:
Nicotine base:
Active ingredient:
nicotine - 23.62 mg;
Excipients:
triglycerides (average chain length) - 27.41 mg, copolymer of basic butyl methacrylate - 21.87 mg, polyethylene terephthalate film 19 µm (on one side can be varnished) - carrier of the layer containing the active substance.
Acrylate base:
acrylic adhesive solution - 185.76 mg, potassium hydroxide - 1.05 mg, croscarmellose sodium - 7.49 mg, aluminum acetylacetonate - 0.09 mg, polyethylene terephthalate film 100 µm, aluminized on one side and siliconized on both sides - the carrier, performs the function of protecting the adhesive layer (removable backing), discarded before use.
Dosage 25 mg / 16 h:
Nicotine base:
Active ingredient:
nicotine - 39.37 mg;
Excipients:
triglycerides (average chain length) - 45.68 mg, copolymer of basic butyl methacrylate - 36.45 mg, polyethylene terephthalate film 19 m (on one side it can be varnished) - carrier of the layer containing the active substance.
Acrylate base:
acrylic adhesive solution - 309.60 mg, potassium hydroxide - 1.80 mg, croscarmellose sodium - 12.50 mg, aluminum acetylacetonate - 0.15 mg, polyethylene terephthalate film 100 µm, aluminized on one side and siliconized on both sides - the carrier, performs the function of protecting the adhesive layer (removable backing), discarded before use.

Hypersensitivity to the components of the drug.

Carefully:

patients who are at risk of cardiovascular disease (have had serious cardiovascular disease, hospitalization for cardiovascular disorders, such as stroke, myocardial infarction, unstable angina pectoris, cardiac arrhythmias, bypass or angioplasty of the coronary arteries, within the previous 4 weeks or with uncontrolled arterial hypertension), NicoretteЃ should be used only after consulting a doctor;

the drug should be used with caution in patients with severe or moderate hepatic impairment, severe renal impairment, and gastric ulcer or duodenal ulcer in the acute stage. In this case, the risk of nicotine replacement therapy should be correlated with the risk of continuing to smoke;

nicotine, both released from substitution therapy and absorbed during smoking, stimulates the release of catecholamines from the adrenal medulla. Therefore, the drug should be used with caution in patients with uncontrolled hyperthyroidism and pheochromocytoma;

patients with diabetes may need to lower their insulin dose after smoking cessation.

Pharmacotherapeutic group: a remedy for the treatment of nicotine addiction

After abrupt cessation of smoking, patients who have daily used tobacco-containing products for a long time may develop a withdrawal syndrome, which includes: dysphoria or depressed mood, insomnia, increased irritability, dissatisfaction or anger, anxiety, impaired concentration, anxiety or impatience, decreased heart rate, increased appetite, or weight gain. The urge to smoke is also an important symptom of withdrawal.

In the treatment of tobacco dependence, nicotine replacement therapy reduces the need for the number of cigarettes smoked, reduces the severity of withdrawal symptoms that occur when smoking cessation in those who decided to quit smoking; facilitates temporary abstinence from smoking, and also helps to reduce the number of cigarettes smoked in those who cannot or do not want to completely quit smoking.

INDICATIONS FOR USE

For the treatment of tobacco dependence by reducing the need for nicotine, the removal of withdrawal symptoms that occur when smoking cessation in patients with appropriate motivation.

CONTRAINDICATIONS

Hypersensitivity to nicotine or other components of the drug.

Carefully

Patients with recent myocardial infarction, unstable angina pectoris or worsening of its course, including Prinzmetal's angina, with severe arrhythmia, recent cerebrovascular disease and / or patients with uncontrolled hypertension should be advised to stop smoking without the help of pharmacological intervention. If such attempts are unsuccessful, the use of the NicoretteЃ patch can be considered, however, since the safety data in this category of patients are limited, such treatment should be started only under strict medical supervision. Patients with diabetes mellitus after smoking cessation and since the beginning of nicotine replacement therapy are recommended to more closely monitor the blood glucose concentration, since a decrease in the content of catecholamines,the release of which is induced by nicotine can affect the metabolism of carbohydrates. Patients with diabetes mellitus may need to lower their insulin dose after smoking cessation.

The drug should be used with caution in patients with severe or moderate hepatic impairment and / or severe renal impairment, since the clearance of nicotine and its metabolites may be reduced, which may increase the risk of adverse events.

Nicotine, both released from substitution therapy and absorbed during smoking, stimulates the release of catecholamines from the adrenal medulla. Therefore, the drug should be used with caution in patients with uncontrolled hyperthyroidism and pheochromocytoma.

Nicotine can exacerbate the symptoms of esophagitis, gastritis or peptic ulcers, therefore, nicotine replacement therapy should be used with caution in this pathology.

APPLICATION DURING PREGNANCY AND DURING BREASTFEEDING

Smoking during pregnancy is associated with risks such as intrauterine growth retardation, premature birth, or stillbirth. Smoking cessation is the single most effective intervention for improving the health of both the pregnant woman and her baby. Quitting smoking early is the best option.

Nicotine crosses the placental barrier and affects the respiratory activity and blood circulation of the fetus. The effect on blood circulation is dose-dependent. Smoking can have serious adverse effects on the fetus and newborn and should therefore be stopped. Therefore, ideally, smoking cessation during pregnancy should be carried out without nicotine replacement therapy.

The risk to the fetus when using Nicorette Ѓ is not fully understood. However, the benefits of nicotine replacement therapy in pregnant women who cannot quit smoking without such treatment significantly outweigh the risk of continuing to smoke. The NicoretteЃ patch should be used in pregnant women only with a high degree of dependence, after consulting a doctor.

Nicotine passes into breast milk in quantities that can affect the baby, even when using the drug in therapeutic doses. Therefore, you should refrain from using the NicoretteЃ patch during breastfeeding. If it was not possible to quit smoking, the use of the drug should be started only after consulting a doctor.

Smoking increases the risk of infertility in both men and women. Studies in vitro have shown that nicotine has a negative impact on sperm quality in men.

DOSAGE AND APPLICATION

Treatment with a transdermal NicoretteЃ patch simulates fluctuations in the concentration of nicotine during the day in a smoker; however, during sleep, nicotine does not enter the body. The use of a transdermal nicotine patch during the day does not cause the disturbances observed when nicotine enters the body during sleep.

NicoretteЃ transdermal patch can be used as monotherapy or in combination with NicoretteЃ chewing gum 2 mg, NicoretteЃ sublingual tablets 2 mg or NicoretteЃ topical spray 1 mg / dose.

If symptoms of an overdose appear (see the 'Overdose' section), the drug should be discontinued immediately.

Children and adolescents

There is no experience with the use of Nicorette Ѓ plaster by adolescents under the age of 18, therefore the drug should be used by persons under 18 years of age strictly according to the doctor's prescription.

Adults

NicoretteЃ transdermal patch can be used in case of sudden smoking cessation, as well as to increase the time intervals between smoking in order to reduce smoking as much as possible to complete smoking cessation.

The patient should do everything possible to permanently quit smoking while being treated with NicoretteЃ patch.

Patients with a high degree of dependence (more than 20 cigarettes per day) are recommended to start with stage 1 of therapy, using 1 patch 25 mg / 16 hours, daily, for 8 weeks.

How to apply a transdermal patch

The patch is applied to the intact skin immediately after waking up in the morning and removed at bedtime. The patch should be applied to dry, clean, undamaged skin that does not contain hair, such as the thigh, upper limb, or chest. It is necessary to change the place of overlap every day: do not use the same area for the next two days. After applying the patch, wash your hands thoroughly to avoid eye irritation from possible exposure to nicotine.

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. Choose a clean, dry area of ??skin that does not contain hair (such as thighs, upper limbs, or chest).

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

4. Attach the stripped portion of the patch 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 adhered.

7. If the patch comes off, put on a new one. Using a skin care oil or talcum powder may interfere with the patch's proper attachment.

In combination with chewing gums, sublingual tablets, topical spray

For smokers with a strong nicotine addiction (more than 20 cigarettes per day) or experiencing an irresistible urge to smoke, or smokers who have not been able to quit using only one type of nicotine replacement therapy, the Nicorette patch can be used to quickly relieve the craving for smoking Ѓ in combination with chewing gums Nicorette Ѓ dosage 2 mg / tablets sublingual Nicorette Ѓ dosage 2 mg / spray for topical application NicoretteЃ dosage 1 mg / dose.

The patch is applied to the intact skin immediately after waking up in the morning and removed at bedtime. The patch should be applied to dry, clean, undamaged skin that does not contain hair, such as the thigh, upper limb, or chest. It is necessary to change the place of overlap every day: do not use the same area for the next two days. After applying the patch, wash your hands thoroughly to avoid eye irritation from possible exposure to nicotine.

Initial therapy:

Treatment should begin with a patch 25 mg / 16 hours (stage 1) in combination with chewing gums 2 mg / sublingual tablets 2 mg / spray for topical application 1 mg / dose. Usually 5-6 chewing gum / sublingual tablets per day or 13 topical spray doses per day are sufficient. The maximum daily dose for chewing gums is 15 pieces, for sublingual tablets - 24 pieces, for a topical spray - 32 doses.

Patients should completely stop smoking during therapy. Usually, the general course of treatment lasts for 8 weeks. After that, the dose of nicotine should be gradually reduced.

Cancellation of combination therapy:

There are two ways to cancel combination therapy.

Method 1: within the next 2 weeks, it is necessary to switch from a patch 25 mg / 16 hours (stage 1) to a patch 15 mg / 16 hours (stage 2), and then, over the next 2 weeks - to a patch 10 mg / 16 hours ( Step 3), while maintaining, if necessary, the number of chewing gums / sublingual tablets / topical spray doses used, as with the Initial Treatment . Further, the number of chewing gums / sublingual tablets / spray doses for topical application is gradually reduced until complete cancellation within the time that the patient needs, depending on his needs, but no later than 12 months after the start of the combination therapy.

Method 2: consists in completely canceling the patch immediately after the end of the Initial therapy phase . Further, the number of chewing gums / sublingual tablets / spray doses for topical application is gradually reduced until complete cancellation within the time that the patient needs, depending on his needs, but no later than 12 months after the start of the combination therapy.

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

SIDE EFFECT

Regardless of the drug used as a treatment for tobacco dependence, some symptoms may be due to nicotine withdrawal due to smoking cessation. These include: dysphoria or depressed mood; insomnia; irritability, discontent, or anger; anxiety; difficulty concentrating; anxiety or impatience; decreased heart rate; increased appetite or weight gain; dizziness or lightheadedness; cough, constipation, and bleeding gums.

After smoking cessation, the incidence of aphthous ulcers, cough and nasopharyngitis may also increase. A causal relationship has not been established.

Nicotine craving, considered a clinically significant symptom, is an important manifestation of nicotine withdrawal after smoking cessation.

The NicoretteЃ patch can cause nicotine-related adverse reactions similar to those seen with other nicotine-containing drugs. Most adverse reactions, according to patient reports, occur in the early phase of therapy and are predominantly dose-dependent.

OVERDOSE

Excessive intake of nicotine during substitution therapy and / or smoking can cause symptoms of overdose.

Symptoms of nicotine overdose can occur in patients with low nicotine intake before treatment or when using different sources of nicotine at the same time.

ѕри передозировке отмечаютс¤ те же симптомы, что и при остром отравлении никотином, а именно: тошнота, рвота, повышенное слюноотделение, боль в животе, диаре¤, потливость, головна¤ боль, головокружение, нарушени¤ слуха и выраженна¤ обща¤ слабость. ѕри применении высоких доз вслед за этими симптомами возможно по¤вление следующих симптомов: снижение артериального давлени¤, слабый и нерегул¤рный пульс, затруднение дыхани¤, упадок сил, коллапс и генерализованные судороги.

Ќикотин в переносимых взрослыми курильщиками дозах может вызвать у детей симптомы т¤желого отравлени¤ и даже привести к летальному исходу. ѕодозрение на отравление никотином у детей должно расцениватьс¤ как неотложное состо¤ние, требующее немедленной госпитализации.

Ћечение передозировки: следует немедленно прекратить применение никотина и назначить симптоматическое лечение. Ќеобходимо удалить пластырь и промыть место наложени¤ пластыр¤ водой. јктивированный уголь снижает всасывание никотина в желудочно-кишечном тракте.

ћинимальна¤ летальна¤ доза при острой передозировке дл¤ некур¤щего взрослого человека составл¤ет 40Ц60 мг никотина.

¬«ј»ћќ??…—“¬»? — ?–”v»ћ» Ћ? ј–—“¬?ЌЌџћ» —–??—“¬јћ»

„еткого клинически значимого взаимодействи¤ между заместительной никотиновой терапией и другими препаратами не установлено. “ем не менее, теоретически, никотин может усиливать гемодинамические эффекты аденозина, т. е. приводить к повышению артериального давлени¤ и частоты сердечных сокращений, а также усиливать ответ на боль (боли в грудной клетке по типу стенокардии), провоцируемый введением аденозина.

ќ—ќЅџ? ” ј«јЌ»я

ѕрименение препарата ЌикореттеЃ сопровождаетс¤ меньшим риском, чем курение.

ѕластырь трансдермальный ЌикореттеЃ следует удал¤ть перед проведением ћ–“ (магнитно-резонансна¤ томографи¤) во избежание получени¤ ожогов.

ќпасность дл¤ маленьких детей

?озы никотина, которые легко перенос¤т взрослые курильщики и курильщики-подростки, могут вызвать т¤желую интоксикацию у детей, что может привести к смерти. ¬ажно не оставл¤ть без присмотра препараты, содержащие никотин, поскольку это может повлечь неправильное их применение и проглатывание детьми (см. раздел Ђѕередозировкаї).

‘ормирование зависимости

ћожет развитьс¤ зависимость от препарата, но она ¤вл¤етс¤ менее опасной дл¤ здоровь¤ и более легко преодолимой, чем зависимость от курени¤.

ќтказ от курени¤

ѕолициклические ароматические углеводороды, содержащиес¤ в табачном дыме, индуцируют метаболизм препаратов, метаболизируемых изоферментом CYP1A2 (и, возможно, CYP1A1). ѕрекращение курени¤ может вызывать замедление метаболизма и, как следствие, увеличение концентрации этих препаратов в крови. Ёто имеет потенциальное клиническое значение дл¤ препаратов с узким терапевтическим индексом, например, теофиллина, такрина, клозапина и ропинирола.

ѕосле прекращени¤ курени¤ в плазме могут также увеличитьс¤ концентрации других препаратов, которые частично метаболизируютс¤ изоферментом CYP1A2, таких как имипрамин, оланзапин, кломипрамин и флувоксамин, хот¤ данные, подтверждающие эту гипотезу, отсутствуют, и возможное клиническое значение подобного эффекта не известно.

ќграниченные данные свидетельствуют о том, что курение может индуцировать метаболизм флекаинида и пентазоцина.

ѕосле использовани¤ пластырь следует сложить клейкой стороной внутрь и утилизировать в недоступном дл¤ детей месте.

ѕредупреждени¤ и меры предосторожности при комбинированной терапии пластыр¤ трансдермального ЌикореттеЃ с резинками жевательными/таблетками подъ¤зычными/спреем дл¤ местного применени¤ аналогичны предупреждени¤м и мерам предосторожности при применении каждого из препаратов по отдельности.

?сли лекарственное средство пришло в негодность или истек срок годности Ц не выбрасывайте его в сточные воды или на улицу! ѕоместите лекарственное средство в пакет и положите в мусорный контейнер. Ёти меры помогут защитить окружающую среду!

¬ли¤ниена способность управл¤ть транспортными средствами, механизмами

The profile of adverse reactions of the drug (dizziness) should be taken into account, which can impair the ability to drive vehicles and engage in other activities that require increased concentration of attention and speed of psychomotor reactions.