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

Active substance: nicotine-polymer complex 11 mg or 22 mg (this amount is equivalent to 2.2 mg nicotine or 4.4 mg nicotine, including 10% excess.) Excipients:

chewing gum core: chewing gum (base) *, xylitol, peppermint oil, sodium carbonate, sodium hydrogen carbonate (for a dosage of 2 mg), potassium acesulfame, levomenthol, magnesium oxide, quinoline yellow E-104 (for a dosage of 4 mg);

inner shell: flavoring "Winterfresh", hypromellose, sucralose, polysorbate 80;

outer shell: xylitol, pregelatinized starch, titanium dioxide,
flavoring "Winterfresh", carnauba wax, quinoline yellow E-104 (for dosages of 4 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 cushion about 15x15x6 mm in size
For a dosage of 4 mg:
square, covered with a light-yellow shell with a brownish or greenish tinted cushion 15x15x6 mm
For both dosages, small irregularities on the sides are allowed.

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 "lifting" that arise when 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 in 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 mouth 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 connection with this, violations binding of nicotine with the simultaneous use of other drugs or changes in the plasma protein concentration for 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 cirrhosis of the liver with negligible hepatic impairment (5 on the Child-Pugh scale) and decreases in patients with cirrhosis of the liver with moderate impaired hepatic function (7 on the Child-Pugh scale).In smokers with concomitant chronic renal failure who received hemodialysis treatment, an increase in the concentration of nicotine in the blood plasma was noted.

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:

- reducing the symptoms of "lifting" that arise when full smoking cessation in patients who have decided to quit smoking;

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

Promotes the removal of pigmented plaque on the teeth, has a whitening effect.

Contraindications:Hypersensitivity to nicotine or other components of the chewing gum.

Carefully:

Chewing gum "Nikorette®" should be applied only after consultation with the physician in patients with disorders of the cardiovascular system, in particular have suffered severe heart disease within 1 month before use (such as stroke, unstable angina, arrhythmia, myocardial infarction, bypass surgery or angioplasty) or with uncontrolled arterial hypertension.

Chewing gum "Nicorete®" 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, the chewing gum "Nicorete®" 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 in breast 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 and not later than 2 hours before the next feeding.

Dosing and Administration:

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

Usually

- chewing gum "Nicorette®" 2 mg (moderate nicotine) should be used if you smoke fewer than 20 cigarettes per day or smoke a first cigarette 30 minutes after waking up,

- chewing gum "Nicorette®" 4 mg (high nicotine) 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"

"Nicorette®" should be used in all cases when there is an irresistible desire to smoke, according to the following scheme:

1. slowly chew the chewing gum until the appearance of a sharp taste.

2. Stop chewing and leave the chewing gum between the inside of the cheek and the gum.

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

Full refusal from smoking.

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

With complete cessation of smoking, the amount 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. Apply chewing gum in this dose should be up to 3 months, after which the daily number of chewing gums should be gradually reduced to a full "cancellation." The drug 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 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.

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.

Application in combination with the transdermal therapeutic system with nicotine (patch) "Nicorete®"

Smokers who failed to quit smoking only with the use of chewing gum,or who want to reduce the daily consumption of chewing gums due to local adverse events, can use the "Nicorette®" patch together with the chewing gum 2 mg.

Initial therapy:

Treatment should be started with a single 15 mg / 16 hour patch, which is placed every day on the intact skin area after waking up in the morning and removed before bedtime, in combination with a chewing gum 2 mg. Apply at least 4 chewing gum 2 mg per day; usually enough 5-6 chewing gums. Do not use more than 15 chewing gums per day. The full dose should be applied within 6 to 12 weeks, after which it should be gradually weaned from the drug.

Weaning from a combination of drugs:

This can be done in two ways. The first method: by using a patch of lower dosage, i.e. the use of a 10 mg / 16 hour patch for 3 to 6 weeks and the subsequent use of a 5 mg / 16 hour patch for 3-6 weeks with the same number of chewing gums of 2 mg, as in the initial treatment, and then gradually reducing the amount of chewing gum by 2 mg for 12 months. Another way is to stop using the patch and gradually reduce the amount of chewing gum 2 mg for 12 months.

Recommended dosage:

Initial therapy
Period of time	Patch	Chewing gum 2 mg
The first 6-12 weeks	1 plaster 15 mg / 16 hours daily	Recommended 5-6 chewing gums per day.
Discouragement - Method 1
The next 3-6 weeks	1 plaster 10 mg / 16 hours daily	Continue to apply chewing gums as necessary
The next 3-6 weeks	1 plaster 5 mg / 16 hours daily	Continue to apply chewing gums as necessary
Up to 12 months		Gradual withdrawal from the use of chewing gum
Discouragement - method 2
Up to 12 months		Gradual withdrawal from the use of chewing gum

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 unfavorableIeffects. In the beginninge lehecontained 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:	Headache
	Common:	Dizziness
The cardiovascular system	Uncommon:	Cardiopalmus
	Very rare:	Atrial rhythm disturbances
Gastrointestinal tract	Often	Gastrointestinal
	meeting:	discomfort, hiccough, nausea
	Common:	Vomiting
Leather:	Uncommon:	Erythema, urticaria
Others:	Often	Sore throat or mouth, pain in the throat
	meeting:	chewing muscles.
	Rare:	Allergic reactions, including angioedema

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.

People with a predisposition to digestive disorders at the beginning of treatment with the chewing gum "Nicorette®" 4 mg may have minor digestive disorders or heartburn; usually this problem is eliminated by slower chewing gum and using an elastic band containing 2 mg 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 a decrease in blood pressure, 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, perform artificial ventilation and appoint oxygen.

Interaction:

- Smoking (but not nicotine) causes an increase in the activity of the isoenzyme 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 relevance in the use of 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.

Persons with a violation of the masticatory function are recommended to use other dosage forms.

If the medicine has become unusable or has expiredexpiration date - do not dispose of it in sewage or on 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:

Form release / dosage:

Erasers chewing Frosty mint 2 mg or 4 mg.

For 15 chewing gums in a blister, 1, 2 or 7 blisters together with instructions for use in a cardboard bundle.

Packaging:(15) - blisters (1) - packs cardboard
(15) - blisters (2) - packs cardboard
(15) - blisters (7) - packs cardboard

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Note:

The marking of the expiry date (the period from the date of manufacture to the date specified in the item "Good to") may be less than 2 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-008020/10

Date of registration:12.08.2010

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: & nbsp10.08.2015

Illustrated instructions

Instructions

Nicorette® (Nicorette®)