Nicorette - instructions for use, dose, side effects, contraindications

The core of the chewing gum: chewing gum (base) * 560 mg, xylitol 302 mg, peppermint oil 30 mg, sodium carbonate 30 mg, acesulfame potassium 2 mg, levomenthol 2 mg, magnesium oxide 1 mg, quinoline yellow E104 1 mg. Chewing Gum Shell: xylitol 294 mg, peppermint oil 9 mg, gum arabic 9 mg, titanium dioxide 7 mg, carnauba wax 1 mg, quinoline yellow E104 0.06 mg.

* Chewing gum base is a mixture of different types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%).

Description:

Dosage 2 mg: square, coated with a white color with smell of mint size 15 x 15 x 7

mm chewing gum

Dosage 4 mg: square, coated with light-brown to light yellow with

greenish shade of color with smell of mint size 15 x 15 x 7 mm chewing gum.

For both dosages allowed small irregularities in to the sides.

Pharmacotherapeutic group:treatment for nicotine addiction

ATX: & nbsp

N.07.B.A Drugs used in nicotine addiction

N.07.B.A.01 Nicotine

Pharmacodynamics:

After a sharp quitting in patients who have used tobacco products for a long time, a withdrawal syndrome may develop, which includes: dysphoria, insomnia, increased irritability, anxiety, impaired concentration, decreased heart rate, increased appetite, or an increase in appetite weight. An important symptom of withdrawal syndrome is also the desire to smoke.

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 with complete quitting in those who choose to quit smoking; facilitates temporary abstinence from smoking, and also helps to reduce the number of smoked cigarettes for those who can not or do not want to completely quit smoking.

Pharmacokinetics:

Nicotine, coming from chewing gum, is quickly absorbed through the mucous membrane of the cheek and is found in the blood after 5-7 minutes. The maximum concentration of nicotine is reached 30 minutes after the beginning of chewing.

The volume of distribution of nicotine with intravenous administration is about 2-3 l / kg, and the half-life is about 2 hours. Nicotine is mainly excreted by the liver, its average plasma clearance is about 70 liters1h. Nicotine it is also metabolized in the kidneys and lungs. Identified more than 20 metabolites of nicotine, which are inferior to him in terms of activity.

The connection of nicotine with plasma proteins is less than 5%. In this regard, violations of the binding of nicotine with the simultaneous use of other drugs or changes in plasma protein levels in various diseases should not have a significant effect on the kinetics of nicotine.

The primary metabolite of nicotine in plasma - cotinine - has a half-life of 15-20 hours, and its concentration exceeds that of nicotine by a factor of 10.

Urine is excreted mainly cotinine (15% dose) and trans-3-hydroxy-cotinine (45% dose). From 10% to 30% of the dose of nicotine is excreted in the urine unchanged.Progressive deterioration of kidney function is accompanied by a decrease in overall nicotine clearance. Its pharmacokinetics do not change in patients with cirrhosis of the liver with negligible hepatic impairment (Child-Pugh index 5) and decreases in patients with liver cirrhosis with moderate impaired hepatic function (Child-Pugh index 7). Smokers who received hemodialysis treatment had an increase in the concentration of nicotine in the blood plasma.

In elderly patients there is a slight decrease in total nicotine clearance, which does not require dose adjustment.

Indications:

Treatment of tobacco dependence by reducing the need for nicotine in the following cases:

reduction in withdrawal symptoms that occur with complete quitting in patients who choose to quit;

with a temporary cessation of smoking;

reduction in the number of cigarettes smoked from those who can not or do not want to completely give up smoking.

Contraindications:

Hypersensitivity to nicotine or other components of the chewing gum.

Carefully:

Chewing gum should be used only after consulting a doctor with patients with cardiovascular disorders,in particular, those who underwent serious cardiovascular diseases during the 1st month (especially, such as stroke, unstable angina, arrhythmia, myocardial infarction, shunting or angioplasty) or with uncontrolled hypertension.

Chewing gum "Nicorette" Fresh Mint should be administered with caution to patients with moderate or severe impairment of liver function, severe kidney failure, exacerbation of duodenal ulcer and stomach.

Nicotine, entering the human body with replacement therapy or smoking, causes the release of catecholamines from the adrenal medulla. In this regard, "Nicorette" Fresh Mint must be used with caution in patients with uncontrolled hyperthyroidism, pheochromocytoma, and diabetes mellitus.

The use of the chewing gum "Nicorette®" Fresh Mint is accompanied by less risk than smoking.

Pregnancy and lactation:

Nicotine penetrates the placenta and is excreted with human milk, and therefore its use may pose a risk to the fetus or child. Patients should be informed of the need to attempt to quit without nicotine replacement therapy.In case of failure of such attempts, the decision to conduct therapy is taken after comparing the possible positive effect and potential harm.

Nicotine is absorbed in small amounts in breast milk even when taken in therapeutic doses, which can negatively affect the health of the child when taking the drug by the nursing mother. In order to reduce the negative effect of nicotine on the baby, the chewing gum "Nicorette" should be used immediately after feeding.

Dosing and Administration:

The dose is selected individually depending on the intensity of smoking.

Usually:

- Nicorete® chewing gum Fresh mint with 2 mg dosage should be used if you smoke fewer than 20 cigarettes a day or smoke a first cigarette after 30 minutes. after waking up,

- chewing gum

Nicorette® Fresh mint

dosage 4 mg should be

Apply if you smoke more than 20 cigarettes a day.

How to apply the chewing gum Nicorete® Fresh mint

Chewing gum Nicorette Fresh mint should be used in all cases when there is an irresistible desire to smoke, according to the following scheme:

1. slow chew

chewing gum before the appearance of a sharp taste of nicotine,

2. stop chewing and leave an elastic band between the inside of the cheek and the gum,

3. when the taste disappears, start chewing the chewing gum again.

Full cessation of smoking

At one time, chew only one chewing gum, stopping smoking.

With a complete cessation of smoking

is determined by the degree of dependence on nicotine and is usually 8-12 pieces per day, but should not exceed 15 pieces per day. Use chewing gum in the indicated amount should be up to 3 months, after which the daily number of gum should be gradually reduced to a complete cancellation. Chewing gum is canceled when its 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 not resume smoking.

Reduction quantities

smoked cigarettes

Chewing gum Nicolette® Fresh mint should be used when you want to smoke, gradually reducing the number of cigarettes smoked per day.

If within 6 weeks it was not possible to achieve decrease in daily

consumption of cigarettes, you should contact a specialist for assistance.

Try to completely abandon cigarettes should be taken as soon as you feel ready for it, but no later than 6 months after the start of therapy. If you could not make a serious attempt to stop smoking during

9 months after the start of therapy, you should consult a specialist.

Regular use of chewing gum for more than 12 months is usually not recommended, but some people require longer therapy to not resume smoking or return to previous levels of tobacco use.

Medical counseling and psychological support at the same time as chewing gum therapy Nicorette® Fresh mint usually improve the effectiveness of therapy. Temporary cessation of smoking Chewing gum Nicorette Fresh mint can be used during periods when it is necessary to refrain from smoking, for example, when staying in places where smoking is prohibited, or in other situations when it is necessary to refrain from smoking (air travel, hospitalization, etc.).

In combination with a transdermal patch

Chewing gum Nicorette Fresh mint with a dosage of 2 mg can also be used together with a plaster in those

situations, when the background of the application of plaster human continues to

periodically feel irresistible urge to smoke, or if you can not quit using only chewing gums or just a band-aid. In combination with the band-aid, chewing gum Nicorette® Fresh mint with a dosage of 2 mg allows you to quickly remove strong urges to smoke when necessary.

Initial therapy:

Treatment should begin with a plaster 25 mg / 16 hours (stage 1) in combination with a chewing gum 2 mg. At the same time apply at least 4 chewing gum 2 mg per day; usually enough 5-6 chewing gums. The number of chewing gums should not exceed 15 pieces per day. Usually the general course of treatment lasts for 8 weeks. After that, the dose of nicotine should be reduced gradually.

The plaster is applied immediately after waking up in the morning and is removed before bedtime. The patch should be applied to a dry, clean, undamaged skin that does not contain hair, for example, hips,

upper extremities or thorax.You need to change the location of the overlay every day: do not use the same area for the next two days.

After applying the patch, wash your hands thoroughly to avoid irritation of the eyes from possible exposure to nicotine.

Abolition of combination therapy: You can cancel combination therapy in two ways.

Method 1: Over the next 2 weeks, you need to switch from a 25 mg / 16 hour patch (Stage 1) to a 15 mg / 16 hour patch (Stage 2) and then for a further 2 weeks on a 10 mg / 16 hour patch (Stage 3 ), while maintaining the amount of chewing gum applied Nicorette® Fresh mint with a dosage of 2 mg, as in Initial therapy. Then gradually reduce the amount of chewing gums to a complete cancellation for the time that the person needs, depending on his needs, but no later than 12 months after the start of the combination therapy.

Method 2: is to completely remove the patch immediately after the end of the step Initial therapy. Then gradually reduce the amount of chewing gum Nicorete® Fresh mint with a dosage of 2 mg until complete cancellation for a time,which is necessary for a person depending on his needs, but no later than 12 months after the start of the combination therapy.

Recommended dose:

Period

time

Place

tyry

Chewing gum 2 mg

The first

8 weeks

plaster 25 mg / 16 h aces (stage 1) daily

When

necessity.

Recommended

5-6 Nicorette chewing gums® Fresh mint with a dosage of 2 mg per day

Cancel - Method 1

The next 2 weeks

1 plaster 15 mg / 16 hours (2nd stage) daily

Continue the use of chewing gum Nicorette® Fresh mint with a dosage of 2 mg by need

The next 2 weeks

1 plaster 10 mg / 16 hours (stage 3) daily

Continue the use of chewing gum Nicorette® Fresh mint with a dosage of 2 mg by need

Up to 12

months

after

start

applied

the

combination therapy

Gradual

the abolition of the Nicorette massacre® Fresh mint with a dosage of 2 mg

Cancel - method 2

Up to 12		Gradual
months		annulment
after		chewing
start		elastic
applied		Nicorette®
the		Fresh mint with
combination of		with a dosage of 2 mg
ro- bathroom
of therapy

At the age of 18, chewing gum can be used only on the recommendation of a doctor! Do not exceed the indicated dose! Wear a chewing gum with you to take advantage of it,if you suddenly want to smoke.

Side effects:Dosage is selected individually depending on the intensity of smoking.

Typically, the chewing gum "Nicorette" Fresh Mint 2 mg should be used if you smoke fewer than 20 cigarettes per day or smoke the first cigarette 30 minutes after waking up,

- chewing gum "Nicorete®" Fresh Mint 4 mg should be used if you smoke more than 20 cigarettes a day or you failed to quit using a chewing gum at a dose of 2 mg.

How to use chewing gum "Nicorette" Fresh Mint

"Nicorette®" Fresh Mint should be used in all cases when there is an irresistible desire to smoke, in accordance with the following scheme: slowly chew the chewing gum until the appearance of a sharp taste. Stop chewing and leave the elastic band between the inside of the cheek and the gum. When the taste disappears, start chewing "Nicorette®" Fresh Mint again.

Full refusal to buy.

Only one pillow should be chewed at a time, stopping smoking.

With complete cessation of smoking, the dose of chewing gum per day is determined by the degree of dependence on nicotine, but usually is 8-12 pieces per day and should not exceed 15 pieces per day.Use chewing gum in this dose should be up to 3 months, after which the daily number of gum should be gradually reduced to a complete cancellation. The rubber is canceled 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 not resume smoking.

Reducing the number of smoked cigarettes.

Chewing gum should be used between smoking episodes to extend the intervals between cigarette smoking in order to minimize cigarette consumption. If within 6 weeks you can not achieve a decrease in daily cigarette consumption, you should seek the help of a specialist.
Try to quit smoking should be taken as soon as you feel ready for it, but no later than 6 months after the start of therapy. If you could not make a serious attempt to quit smoking within 9 months after the start of therapy, you should contact a specialist.

Regular use of chewing gum for more than 12 months is usually not recommended.However, some former smokers may require longer treatment with chewing gum to prevent a return to smoking or the previous level of tobacco use.

Simultaneous medical counseling and psychological support usually improve the effectiveness of therapy.

Regular use of chewing gum for more than 12 months is usually not recommended, but some people require longer therapy to not resume smoking

Temporary cessation of smoking

Chewing gum can be used during periods when it is necessary to refrain from smoking, for example, when staying in places where smoking is prohibited, or in other situations when it is necessary to refrain from smoking.

At the age of 18, chewing gum can be used only on the recommendation of a doctor!

Do not exceed the indicated dose!

Wear a chewing gum with you to take advantage of it if you suddenly want to smoke.

In the recommended dose, the chewing gum "Nicorette®" does not cause serious adverse effects. At the beginning of treatment contained in the chewing gum nicotine can sometimes cause mild irritation of the throat and increased salivation. When swallowing excessive amounts of dissolved nicotine at the beginning of treatment, hiccups are possible.

Excessive use of Nicorette® chewing gum by persons who do not have the habit of inhaling tobacco smoke can lead to nausea, weakness, or headaches (similar to those experienced in such patients by inhalation of tobacco smoke).

Most adverse effects are dose-dependent and occur in the first 3-4 weeks of treatment.

Some symptoms, such as dizziness, headache and sleep disturbances, may be associated with withdrawal symptoms arising from abstinence from smoking. After quitting smoking, aphthous ulcers may occur with increased frequency in patients.

In persons with a predisposition to digestive disorders at the beginning of treatment with a chewing gum "Nicorete®" with a dosage of 4 mg, minor digestive or heartburn disorders are possible; Usually this problem is eliminated by slow chewing gum or using a gum containing 2 mg of nicotine (if necessary with shorter intervals).

Symptom frequency: very common (> 1/10), often occurring (> 1/100, <1/10), infrequent (> 1/1000, <1/100), rare (> 1/10000, <1 / 1000), very rare (<1/10000).

Organs and organ systems	Degree of occurrence of a symptom	Symptom
central nervous system	Very common: Common:	Headache Vertigo
The cardiovascular system	Uncommon: Very rare:	Heart palpitations Atrial fibrillation
Gastrointestinal tract	Very common: Common:	Gastrointestinal discomfort, hiccough, nausea Vomiting
Leather:	Uncommon:	Erythema, urticaria
Others:	Very common: Rare:	Sore throat or mouth, muscular jaw pain Allergic reactions, including angioedema

Overdose:

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

Overdose Symptoms are similar to those in acute nicotine poisoning and include nausea, salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing impairment and severe weakness.When applying high doses of nicotine, there may be arterial hypotension, a weak and irregular pulse, shortness of breath, circulatory collapse, and generalized convulsions.

Nicotine in adult-dose smokers doses can cause severe symptoms of intoxication in young children, including fatalities.

Treatment of overdose: should immediately stop using nicotine and prescribe symptomatic treatment. Activated carbon reduces the absorption of nicotine in the gastrointestinal tract. If necessary, give artificial respiration and oxygen.

Interaction:

- Smoking (but not nicotine) causes an increase in activity CYP1A2. After cessation of smoking, a decrease in the clearance of the substrates of this enzyme can be observed. This may lead to an increase in the levels of certain drugs in the blood plasma, which has potential clinical significance when using drugs with a small breadth of therapeutic effect, such as theophylline, Tacrine, clozapine and ropinirole.

- Limited evidence suggests that smoking can induce the metabolism of flecainide and pentazocine.

Special instructions:

Chewing gum can be glued to the denture and in rare cases, damage it.

Patients with diabetes after smoking cessation may need to lower their insulin doses.

If the medicine has become unusable or the expiration date has expired, do not throw it into sewage or into the street! Place the drug in a bag and put it in the trash. These measures will help protect the environment!

Effect on the ability to drive transp. cf. and fur:

The negative impact on the ability to drive a car and work with mechanisms is not established.

Form release / dosage:Erasers chewing Fresh mint 2 mg or 4 mg. For 6 or 15 chewing gums in a blister. By 1 (blister for 6, 15 chewing gum), 2 (blister for 15 chewing gums) or 7 (blister for 15 chewing gum) blisters along with instructions for use in a cardboard bundle.

Storage conditions:

At a temperature not higher than 25 ° C in a place inaccessible to children.

Shelf life:

3 years.

Do not use after expiration. shelf life.

Note:

The marking of the expiration date (the period from the date of manufacture to the date specified in the item "Good to") may be less than 3 years for 1 month.Do not use the drug after the expiry date,

indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-001355/08

Date of registration:29.02.2008

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

McNeil AB, Sweden

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp13.08.2015

Illustrated instructions

Instructions

Nicorette® (Nicorette®)