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

povidone (K90), methylcellulose, saline in (microcrystalline cellulose 98%, silicon dioxide colloid 2%), magnesium stearate, flavoring Lemon 501163 TP0551, aspartame, flavoring 501438 AP1051.

Description:Round tablets with a flat surface of white or almost white color, with bevelled edges, with an embossed inscription on one side "N2".

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 an abrupt withdrawal from smoking, patients may develop a withdrawal syndrome, which includes: dysphoria, insomnia, increased irritability, anxiety, impaired concentration, decreased heart rate, increased appetite or weight gain. 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 the number of cigarettes to be smoked, reduces the symptoms of "cancellation" arising from the complete cessation of smoking in those who choose to quit smoking, facilitate temporary abstinence from smoking,and also helps to reduce the number of smoked cigarettes in those who can not or do not want to completely give up smoking.

Pharmacokinetics:

After placing under the tongue, the tablet slowly breaks down and dissolves in the saliva. Free nicotine then absorbed through the mucosa of the oral cavity and enters the systemic circulation.

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 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-hydroxycotinin (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. It does not change the pharmacokinetics in patients with hepatic cirrhosis and slightly severe impaired liver function

(5 points on the Child-Pugh) and reduced in patients with liver cirrhosis with moderate hepatic impairment (7 points on the Child-Pugh). Smokers with concomitant chronic renal failure treated with hemodialysis, noted the increase in nicotine concentration 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:

reducing the symptoms of "lifting" that arise when full smoking cessation in patients who have 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 drug.

Carefully:

The drug should be used only after consultation with a doctor, after assessing the risk / benefit ratio:

patients with cardiovascular disorders, in particular, suffered serious cardiovascular diseases during the last month (especially, such as stroke, unstable angina, arrhythmia, myocardial infarction, shunting or angioplasty) or with uncontrolled hypertension.

patients with moderate or severe impairment of liver function, severe renal failure, exacerbation of esophagitis, peptic ulcer disease duodenum 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®" should be used with caution in patients with uncontrolled hyperthyroidism, pheochromocytoma, and diabetes mellitus.

Use in children under 12 years of age should only be after a thorough assessment of the risk / benefit ratio.

The use of the drug "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 the possible positive effects for the mother and the potential harm to the fetus, as well as breastfeeding. Pregnant and lactating women are admitted only after consultation with the attending physician.

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. FROM To reduce the negative effect of nicotine on a child, the drug "Nicorette" should be used immediately after feeding.

Dosing and Administration:

Children and teenagers.

The experience of the use of "Nicorette®" by adolescents under the age of 18 is not available, therefore, the drug "Nicorette®" should be used by persons under the age of 18 strictly according to the doctor's prescription.
Adults.

Apply sublingually. Tablets should be kept under the tongue until completely dissolved - about 30 minutes.

During the first days after the beginning of treatment, unpleasant sensations in the oral cavity in the throat may occur. After a while these sensations are invisible.

The initial dose should be selected individually, depending on the degree of tobacco dependence. Patients with a low degree of dependence treatment should start with 1 tablet "Nicoretge®" at the reception. Smokers with a higher degree of dependence (Fagerstrom test for nicotine dependence> 6 points, or the number of cigarettes smoked per day exceeds 20) and patients who failed to quit using 1 tablet of 2 mg should begin treatment with a 2- x tablets of 2 mg per reception. At the beginning of the course of treatment, the tablets should be taken every 1-2 hours; 8- 12 tablets of 2 mg per day, usually enough.

During the day should not take more than 30 tablets of 2 mg.

Full refusal from smoking.

Take the drug for at least 3 months. Then gradually reduce the number of tablets used. When the daily intake of the drug drops to 1 -2 tablets, its use should be discontinued.

Reducing the number of smoked cigarettes.

The tablet should be taken between episodes of smoking to extend the intervals between cigarette smoking in order to minimize cigarette consumption. If after 6 weeks of the drug has not been able to achieve a reduction in daily cigarette consumption, you should consult a doctor-specialist.

The patient should try to stop smoking when he is ready for it, but no later than 6 months after the start of treatment. If within 9 months after the beginning of therapy to stop smoking it was not possible, it is necessary to address for consultation with a specialist.

It is not recommended to take the medication regularly for more than 12 months. Some people who manage to quit smoking may need a longer time to take the drug in order to minimize the risk of resumption of smoking. After the end of the course of treatment, however, it is desirable for the patient to have several tablets, because at any time there may be a spontaneous desire to smoke.

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

Tablets can be used in periods when you need to temporarily give up smoking, for example, when you are in places where smoking is prohibited, or in other situations when you need to refrain from smoking.

Do not exceed the indicated dose!

Side effects:

Undesirable reactions when taking nicotine tablets are similar to those when taking nicotine in other dosage formsand are dose-dependent. Most adverse reactions occur in patients at 3-4 weeks of treatment with the drug.

Dizziness, headache, insomnia, may be manifestations of the "cancellation" syndrome caused by the refusal of smoking. If you quit smoking, the incidence of aphthous stomatitis may increase. The connection of these phenomena with the use of the drug "Nicorente®" is not obvious.

Classification of adverse reactions by frequency: very common (> 1/10), frequent (> 1/100, 1/10) are 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:	dizziness
Gastrointestinal	Often	Gastrointestinal
tract	meeting:	discomfort, hiccups,
		nausea
Respiratory system	Often	Cough. Rhinitis
	meeting:
Cardiovascular	Often	Cardiopalmus
system	meeting:
	Rare:	Atrial fibrillation
Other	Common	Sore throat, irritation of the oral mucosa, dryness in the throat

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, increased salivation, abdominal pain, diarrhea, hyperhidrosis, 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, vascular collapse, and generalized convulsions. Nicotine in doses carried by adult smokers can cause severe symptoms of intoxication in young children, including fatal.

Treatment of overdose: should immediately stop using nicotine and prescribe symptomatic treatment. Activated carbon reduces the absorption of nicotine in the gastrointestinal tract.

Interaction:

Smoking (but not nicotine) leads to an increase in the activity of the CUR1A2.0 enzyme from smoking can cause a decrease in the clearance of some drugs metabolized by this enzyme, and thus lead to an increase in their serum concentration. This pattern should be borne in mind when taking drugs with a narrow therapeutic range, such as theophylline, Tacrine, clozapine and ropinirole.

Serum concentration of other drugs that are partially metabolized by the enzyme CYP1A2, such as imipramine, olanzapine, clomipramine and fluvoxamine may also increase after cessation of smoking, but there is no conclusive evidence to support this, so it is impossible to talk about the clinical significance of this effect on the pharmacokinetics of the aforementioned medicines.

A few data indicate that the metabolism of flecainide and pentazocine can also be induced by smoking.

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.

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!

Form release / dosage:

Tablets of sublingual lemon 2 mg.

10 tablets in a blister pack.

By 2, 3, 9 or 10 blisters in a pack of cardboard.

Packaging:(10) - blisters (10) - packs of cardboard
(10) - blisters (2) - packs cardboard
(10) - blisters (3) - packs cardboard
(10) - blisters (9) - 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-002695/10

Date of registration:31.03.2010

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®)