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

Active substance: nicotine-polymer complex (nicotine resinate, containing 20 % nicotine) 11, mg or 22 mg (this amount is equivalent to 2.2 mg nicotine or 4.4 mg nicotine, including 10% excess).

Excipients:

The core of the chewing Elastics: chewing gum (base) * 560 mg / 560 mg, xylitol 314 mg / 302 mg, peppermint, oil 30 mg / 30 mg, sodium carbonate 20 mg / 30 mg, sodium bicarbonate (for a dosage of 2 mg) 10 mg / -, potassium acesulfame 2 mg / 2 mg, levomentol 2 mg / 2 mg, magnesium oxide 1 mg / 1 mg, quinoline yellow E-104 (for a dosage of 4 mg) - / 1 mg.
Inner shell: Scent Stinging Spicy Mint SN679712 11 mg / 11 mg, hypromellose 10.5 mg / 10.5 mg, sucralose 4 mg / 4 mg, polysorbate 80 0.5 mg / 0.5 mg.

Outer sheath: xylitol 271 mg / 271 mg, acacia gum (gum, miarabic), 12 mg / 12 mg, titanium dioxide 6 mg / 6 mg, Flavoring Spicy Spinach SN679712 4 mg / 4 mg, carnauba wax 1 mg / 1 mg, quinoline yellow E-104 (for a dosage of 4 mg) - / 0.078 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, a small cushion about the size 15x15x6 mm.

For a dosage of 4 mg:

square, covered with a light-yellow shell with a brownish or greenish tint of color, a cushion approximately the size 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 quitting in patients who 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. gain in 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 reduces the number of smoked cigarettes in those who can not or does 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 after 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 changes in the concentration of plasma proteins 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 negligible liver function abnormalities (score 5 on the Child-Pugh scale) and decreases in patients with liver cirrhosis with moderate impaired hepatic function (score 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:

- 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:

The Nicorrette® gum should only be used after consultation with a physician for patients with cardiovascular disorders, in particular serious cardiovascular diseases for 1 month before the application (such as stroke, unstable angina, arrhythmia, myocardial infarction, shunting 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.

Concerning; chewing gum Nicorete® should be used with caution in patients with uncontrolled hyperthyroidism, pheochromocytoma, as well as with diabetes mellitus.

The use of Nicorette® chewing gum is associated with a lower risk than smoking.

Pregnancy and lactation:

Nicotine penetrates the placenta and is excreted in breast milk, due to which its use may pose a risk to the fetus or the baby. 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 Nicoret® should be used immediately after feeding and no 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 Nicorete® 2 mg should be used if you smoke fewer than 20 cigarettes a day or smoke your first cigarette 30 minutes after waking up,

- chewing gum Nicorete® 4 mg should be used if you smoke more than 20 cigarettes a day.

How to use Nicorete® Chewing Gum

Chewing gum 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 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 complete cessation of smoking, the amount of chewing gum per day 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. 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 cigarettes smoked

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

If within 6 weeks you can not achieve a decrease in daily cigarette consumption, you should seek the help of a specialist.

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 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, but some people require longer therapy to not resume smoking or return to previous levels of tobacco use. Medical counseling and support, psychological support along with chewing gum therapy Nicorette® usually increase 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 (air travel, hospitalization, etc.).

In combination with a patch (transdermal therapeutic system)

Niacorete® chewing gum with a dosage of 2 mg can also be used in conjunction with a patch in those situations where, with the use of a patch, a person continues to periodically experience insurmountable urges to smoke, or if it was not possible to quit using only chewing gum or just a band-aid.

In combination with the band-aid, Nicorete® chewing gum with a dosage of 2 mg allows you to quickly remove strong urges to smoke when necessary.

Initial therapy:

Treatment should begin with a patch in a dosage of 15 mg / 16 hours (1 stage) in combination with a chewing gum of 2 mg. A 15 mg / 16 hour patch is applied for 6-12 weeks, applying it every morning to a clean, undamaged, hair-free area of the skin of the shoulder or thigh and taking off before bed. 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.

Abolition of combination therapy:

You can cancel combination therapy in two ways.

Method 1: for the next 3-6 weeks, it is necessary to switch from a 15 mg / 16 hour patch (Stage 1) to a patch with a 10 mg / 16 hour dose (Stage 2) and then for a further 3-6 weeks on a patch with a dosage of 5 mg / 16 hours (stage 3), while maintaining the amount of chewing gum applied 2 mg, as in Initial therapy. Further gradually, the amount of chewing gums is reduced to a complete cancellation for a time,which is necessary for a person depending on his needs, but no later than 9 months after the start of the combination therapy.

Method 2: is to completely remove the patch immediately after the end of the stage Initial therapy. Then gradually reduce the amount of chewing gum 2 mg to complete cancellation for the time that * is necessary for a person depending on his needs, but not later than. 9 months after the onset of combined therapy.

Recommended dose:

Initial therapy
Period of time	Patch	Chewing gum 2 mg
The first 6-12 weeks	1 plaster 15 mg / 16 hours (1 stage) daily	If necessary. Recommended 5-6 chewing gum 2 mg per day
Cancel - Method 1
The next 3-6 weeks	1 plaster 10 mg / 16 hours (2nd stage) daily	Continue to use chewing gum 2 mg if necessary
The next 3-6 weeks	1 plaster 5 mg / 16 hours (stage 3) daily	Continue to take chewing gum 2 mg as needed
Up to 9 months after the application of the combined '		Gradual elimination of chewing gum 2 mg "

of therapy I I
	Cancel -	- method 2
Up to 9 months after		Gradual elimination of chewing gum
the use of combined		2 mg
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:

In the recommended dose, the chewing gum Nicorete® 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).

Classification of undesirable reactions by frequency: Very frequent (> 1/10), frequent (> 1/100, 1/10), less frequent (> 1/1000, <1/100), rare (> 1/10 000, < 1/1000), very rare (<10 0000), including isolated cases.

Organs and Systems	Power	Symptom
bodies	occurrence
	symptom
Central nervous	Often	Headache
system	meeting:
	Common:	Dizziness

Cardiovascular system	Uncommon: Very rare:	Cardiopalmus Atrial rhythm disturbances
Gastrointestinal tract	Often	Gastrointestinal
	meeting:	discomfort, hiccough, nausea
	Common:	Vomiting
Leather:	Infrequently meeting:	Erythema, urticaria
Others:	Often	Pain in the throat or in the mouth,
	meeting:	pain in the chewing muscles
	Rare:	Allergic reactions,
		including angioedema

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

In individuals with predisposition to digestive disorders, at the beginning of treatment with a chewing gum, Nicorette® 4 mg, minor digestive or heartburn disorders are possible; 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. The risk of poisoning due to ingestion of the chewing gum is small, since absorption is slow and partial.

Overdose Symptoms similar to those with 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 smoking cessation, there may be a decrease in the clearance of the substrates of this enzyme! 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.

The use of Nicorette® chewing gum is associated with a lower risk than smoking.

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:

Form release / dosage:

Erasers chewing Spicy mint 2 mg and 4 mg.

For 15 chewing gums in PVC / PVDC / A1 / vinyl acrylic blister, for 1,2 or 7 blisters together with instructions for use in a cardboard bundle.

Packaging:(15) - blisters (1) / contour squares, instructions for use, cardboard pack / - cardboard pack
(15) - blisters (2) / contourcell pack, instructions for use, cardboard pack / - cardboard pack
(15) - blisters (7) / contour squares, instructions for use, cardboard pack / - cardboard pack

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-000280

Date of registration:17.02.2011

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®)