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:

For a dosage of 2 mg:

Square, covered with a shell of white or almost white color, the cushion is approximately the size 15x15x6 mm

for a dosage of 4 mg:

square, covered with a cover of light yellow color with a brownish or greenish white color pad size of about 15 x 15> <6 mm for both dosages allowed to have small irregularities on 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 smoking cessation in patients routinely use tobacco-containing products for a long time, may develop "cancellation" syndrome, which includes: dysphoria, insomnia, irritability, anxiety, impaired concentration, decreased heart rate, increased appetite or gain in weight. An important symptom of the syndrome of "withdrawal" is also the desire to smoke.

In the treatment of tobacco dependence, Nicotine replacement therapy reduces the need for a number of cigarettes smoked, reduces the severity of symptoms of the syndrome of "cancellation", arising from the full smoking cessation for those who have decided to quit smoking, facilitates temporary abstinence from smoking, as well as helps to reduce the number of cigarettes smoked those who can not or do not want to completely give up smoking.

Pharmacokinetics:

Nicotine, coming from the 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 l / h. 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 with hypoalbuminemia 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 does not change in patients with liver cirrhosis with mild liver function abnormalities (Child-Pugh score 5) and decreases in patients with liver cirrhosis with moderate impaired hepatic function (Child-Pugh score 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:

- decrease in the symptoms of the "withdrawal" syndrome that occur with complete quitting in patients who decided to quit smoking;

- 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 "Nicorette" should be used only after consultation with a doctor to patients with cardiovascular disorders, in particular who underwent serious cardiovascular diseases for 1 month prior to application (such as stroke, unstable angina, arrhythmia, myocardial infarction, shunting or angioplasty) or with uncontrolled hypertension.

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

Nicotine, entering the human body with replacement therapy or smoking, causes the release of catecholamines from the adrenal medulla. In connection with this, the chewing gum "Nicorette" should be used with caution in patients with uncontrolled hyperthyroidism, pheochromocytoma, and also with diabetes mellitus.

The use of chewing gum "Nicorette" is accompanied by a lower 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 the case of failure of such attempts, the decision to conduct therapy is taken after comparing a possible positive effect for the mother and potential harm to the fetus.

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:

chewing gum Nicorete® Fresh mint with a dosage of 2 mg should be used if you smoke fewer than 20 cigarettes per 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:

Initial therapy

The first 8 weeks .......1 plaster 25 mg / 16 hours (stage 1) daily .....

If necessary. Recommended 5-6 chewing gum Nicolette® Fresh mint with a dosage of 2 mg per day

Cancel - Method 1

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

Continue application of chewing rubber bands Nicotrette® Fresh mint with a dosage of 2 mg as needed

Next 2 ....................1 plaster 10 mg / 16 hours daily.............. Continue application of Nicorette Fresh mint with a dosage of 2 mg as needed

Up to 12 months after start applythe combinirobathroom therapy ................ Gradual cancellation of gumgum Nicorette Fresh mint with dosage 2 mg

Cancel - method 2

Up to 12 months after start applythe combinirobathroom therapy ................ Gradual cancellation of gumgum Nicorette Fresh mint with dosage 2 mg

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:

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 consumption 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 the symptoms that occur in such patients when inhaled by tobacco smoke).

Organs and organ systems	Degree of occurrence of a symptom	Symptom
central nervous system	Very common: Common:	Headache Headache
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:	Often meeting: Rare:	Sore throat or mouth, muscular jaw pain Allergic reactions, including angioedema

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

Persons with a predisposition to digestive disorders at the beginning of treatment with a chewing gum "Nicorette" of 4 mg may have minor digestive or heartburn disorders; Usually this problem is eliminated by slower chewing of the gum and using a gum containing 2 mg of nicotine (if necessary, at shorter intervals).

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, prescribe artificial ventilation (IVL) 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 concentration 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:

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

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

The use of chewing gum "Nicorette" is accompanied by a lower risk than smoking.

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

Form release / dosage:

Erasers chewing Fresh fruit 2 mg or 4 mg. For 6 or 15 chewing gums in a blister, 1 (blister for 6, 15 chewing gum), 2 (blister for 15 chewing gums) or 7 (a blister pack of 15 chewing gums) blisters along with instructions for use in a cardboard bundle.

Packaging:(15) - packings, cellular, planimetric (1) - packs cardboard
(15) - packings, cellular, outline (2) - packs, cardboard
(15) - packings cellular planimetric (7) - packs cardboard

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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 product after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-004064/09

Date of registration:25.05.2009

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: & nbsp12.08.2015

Illustrated instructions

Instructions

Nicorette® (Nicorette®)