Nikvitin Mini - instructions for use, dose, side effects, contraindications

The central nervous system has a pronounced effect on the central nervous systemC and cardiovascular system. When entering the body with tobacco smoke causes a habit, refraining from smoking is accompanied by a craving for smoking and symptoms of "cancellation." The craving for smoking and the symptoms of "cancellation" include a strong desire to smoke a cigarette, decreased mood, its fluctuations, sleep disturbances, increased irritability, emotional instability, anxiety, problems with concentration, nervousness, increased appetite and / or weight gain. mild somatic disorders (headache, myalgia, constipation, fatigue, etc.). A craving for smoking and other symptoms of failure from nicotine are most expressed in the first weeks of quitting, then they weakened. It has been clinically proven that tablets replace some part nicotine, which comes with a cigarette, and ease the symptoms of quitting smoking the period of their greatest intensity.

Pharmacokinetics:

Suction

"Pikvitin" Mini ", tablets for resorption (mint), completely dissolve in the oral cavity, and all The amount of nicotine that contained in a pill becomes available for suction when grisbukkalnom introduction (by placing the tablet between the top lip and gum until complete resorption) or oral intake (swallowing). As a rule, in the oral cavity tablets "Pikvitin® Mini" completely dissolved within 10 minutes. When taking tablets with a dosage of 1.5 mg every hour the equilibrium Cmax and C_min nicotine concentration in plasma are 18.4 and 15.0 ng / ml respectively.

Average maximum concentration nicotine in plasma after a single taking a tablet of 4 mg is approximately 9.1 ng / ml.

Distribution

Since the degree of binding of nicotine to plasma proteins are low (4.9%), volume nicotine distribution is high (2.5 l / kg). Distribution of nicotine in tissues depends on the pH value. The highest concentrations of nicotine are found in the brain, stomach, kidneys and liver.

Metabolism

Nicotine is extensively metabolized with formation of several metabolites. All nicotine metabolites possess less active than the original compound. Nicotine metabolism occurs mainly in the liver, in less in the lungs and kidneys. AT mostly nicotine metabolized into cotinine, to a lesser extent in nicotine N’- oxide.The half-life of cotinine is 15-20 hours, and its content in the blood is K) times that of nicotine. Subsequently, cotinip is oxidized to trans-3'-hydroxycotinin. In the urine, this metabolite nicotine is an prevailing. Both compounds - nicotine and cotinip - undergo conjugation with glucuronic acid.

Excretion

The half-life of nicotine is approximately 2 h (range 1-4 h). The total nicotine clearance varies in the range of 62-89 l / h. The extrarenal nicotine clearance is about 75% of the total clearance. Nicotine and its metabolites are almost completely excreted together with urine. Renal excretion of unchanged nicotine is largely dependent on the pH of the urine; higher excretion rates were noted with acid pH of urine.

Indications:"Niquitin® Mini", pills for resorption (mint) 1.5 mg and 4 mg reduce and (or) prevent cravings for smoking and symptoms that occur in tobacco-dependent people after quitting. The drug reduces the need for the number of cigarettes smoked; reduces the severity of withdrawal symptoms, arising at complete abandonment of smoking in those who decided to quit smoking; facilitates temporary abstinence from smoking, and also contributes to decrease in the number of smoked cigarettes from those who can not or do not want completely give up smoking. "Niquitin® Mini", tablets for resorption (mint) 1.5 mg and 4 mg. it is desirable to apply in combination with a psychological support program.

Contraindications:

- when hypersensitivity to nicotine or to any of the auxiliary substances of the preparation;

- children under 12 years of age and non-smokers;

- contains soybean oil, contraindicated in people with allergies to peanuts and soy.

Carefully:

Use with caution and only after consultation with a physician in cases presence of diseases and conditions:

- cardiovascular diseases (see section "Special instructions");

- patients hospitalized for myocardial infarction;

- severe cardiac rhythm disturbances, cerebrovascular diseases (stroke);

- uncontrolled arterial hypertension (see section "Special instructions");

- severe renal dysfunction and moderate or severe hepatic insufficiency (see section "Special instructions");

- hyperthyroidism (dysfunction of the thyroid gland), pheochromocytoma (adrenal gland tumor) (see section "Special instructions");

- - diabetes mellitus (see section "Special instructions");

- stomach ulcers / duodenal ulcers or inflammation of the esophagus;

- predisposition to allergic reactions, such as angioedema and urticaria.

Pregnancy and lactation:

Quitting smoking is a priority and the most effective measure for

improving the health of a smoking pregnant woman a woman and her child. The earlier

woman refuses to smoke, so better. However, if the mother can not (or

if this is considered unlikely) quit smoking without help pharmacological measures (medicines), her can be appointed NRT, and in this the risk to the fetus will be less than in the case of tobacco smoking. Outside of any doubts, a complete cessation of smoking and from taking drugs NZT is an The best option, however, if this is It is impossible, pregnant women can administer drugs NZT as safer alternative to smoking.

The advantage of using tableted dosage forms is the existence of periods free from nicotine intake. However, in the case of symptoms such as severe nausea and (or) vomiting, there may be a need in the use of patches.When use of a plaster is desirable Remove it at night to once again not to expose the fruit to the effects of nicotine.

Lactation

During the course of taking NRT in breast milk of the mother is detected

relatively small amount of nicotine.

In comparison with the effect of passive smoking, the impact of these quantities on

the child is less dangerous. Irregular use of the drug allows

minimize the content of nicotine in difficult milk and provides

ability to feed in periods when the content of nicotine in

milk is minimal.

Dosing and Administration:

Recommendations for use

The dosage of tablets is selected in dependence on the degree of nicotine

dependence of the patient.

"Niacitin® Mini" tablets for resorption (mint) 1.5 mg fit

for those who smoke no more than 20 cigarettes a day.

"Niquitin® Minn", tablets for resorption (mint) 4 mg. suitable for

smokers who smoke more than 20 cigarettes a day.

One tablet should be absorbed in the mouth until complete dissolution. Occasionally The tablet should be moved from one of the oral cavity to the other and

rassasyvat until it is not dissolve completely (about 10 minutes). The tablet should not be chewed or swallow.

During the resorption of the tablet is not it is recommended to drink or eat food.

Usually. appropriate psychological therapy increases the effectiveness of treatment.

Adult patients (18 years and older)

Full cessation of smoking

The patient must make every effort to complete quitting during the course treatment with "Iicquitin® Mini"tablets for resorption (mint).

One tablet is recommended to dissolve everytime. when there is a desire

smoking.

Every day you need to dissolve a sufficient number of tablets, usually

from 8-12 to 15 tablets.

To quit smoking completely continue taking the drug for 6

weeks, and then gradually reduce consumption of pills. When consumption

tablets up to 1-2 per day, taking the drug can be stopped.

Patients who completed the course of admission drug, can wear tablets with you

in case of a situation in which they can feel the desire

to smoke a cigarette.

Patients who managed to quit Smoking, but experiencing difficulties

when you cancel the drug, it is recommended ask for more help and

advice to the doctor.

Gradual quitting smoking

For smokers who do not wish or not able to stop smoking immediately

it is recommended that the smoking.

It is recommended to dissolve tablets every time a strong

desire to smoke to maximize reduce the number of smoked cigarettes and

maximize time abstinence from smoking.

The daily number of tablets varies and depends on the patient's needs. However, less, do not take more than 15 tablets per day.

If the reduction in the number of smokers cigarettes after 6 weeks of treatment

happened, it is recommended to apply for additional help and advice to

the doctor.

Reduction in the number of smoked cigarettes should lead to a full kazu

from smoking. This should be achieved as fast as possible. When the quantity

smoked cigarettes is reduced to a level at which the patient feels that he is able to completely To refuse from cigarettes, it is recommended to begin reception of a preparation under the scheme or plan "full quitting smoking ", described above.

If within 6 months after the commencement of treatment an attempt was made to completely quit smoking, it is recommended that to the doctor.

Reducing the number of smoked cigarettes

For those. who want to reduce the number of cigarettes smoked and has no definite plans to completely quit smoking.

Tablets are recommended to dissolve each time when there is a strong desire to smoke, in order to minimize the number of cigarettes smoked and maximally to enlarge abstention time from smoking. The patient should be encouraged to promptly and completely quit smoking.

The daily amount of tablets varies depending on the needs of the patient. However, do not take more than 15 tablets a day.

After 6 months from the start of treatment, the patient did not smog attempt to completely quit smoking and needs regular tablet administration, it is advisable to seek additional help and advice to the doctor.

ATbelt failure

To control the symptoms that occur in tobacco-dependent individuals with refraining from smoking, including cravings for smoking, it is recommended to dissolve tablets every 1 to 2 hours.Ps should be taken more than 15 tablets a day. The patient should be encouraged to promptly and completely quit smoking. Sang 6 months after the start of treatment, the patient was never able to make an attempt to quit smoking completely and felt the need for a regular admission tablets, it is recommended to consult for additional help and advice to the doctor.

Children and teens

Adolescents aged 12-17 years can use tablets for resorption only on the advice of a doctor! Dosage regimen in children 12-17 years old corresponds to the scheme of total failure from smoking, described for adults. If teenagers are not ready or unable to completely stop smoking, it is necessary to consult a doctor.

safety and effectiveness in smoking children have not been studied. Use in children younger than 12 years is contraindicated.

Side effects:

Undesirable reactions that develop as a result of oral intake of MZT drugs are similar to the effects of nicotine administration in the body in other ways, including smoking. These reactions are due to pharmacological effects of nicotine, some of these effects are dose-dependent.In recommended doses, the drug "Piquitin® Mini", as a rule, does not cause serious undesirable phenomena. When the drug is used in doses exceeding the recommended levels, smokers who do not delay smoking may have a risk of nausea, weakness, dizziness and headache.

Separate symptoms such as depression, mood swings, drowsiness, decreased concentration, irritability, anxiety, increased appetite and insomnia, may be due to refusal of smoking. In persons who quit smoking (in various ways), may To develop such undesirable phenomena as weakness, headache pain, dizziness sleep, cough or flu-like syndrome.

Violation of from the immune systems

Very rarely (<1 / 10,000): anaphylactic reactions.

Mental disturbance

Often (> = 1/100. <1/10): irritability, anxiety, impairment sleep, including abnormal sleep.

Infrequently (> 1 / 1,000, <1/100): nervousness, depression.

Violation of the nervous systems

Often (> 1/100, <1/10): dizziness, headache.

The frequency is unknown; convulsions.

Violation of the heart

Infrequently (> 1 / 1,000, <1/100): sensation palpitations, tachycardia

Disturbances from respiratory system, chest organs and

the mediastinum

Often (> 1/100, <1/10): cough, sore throat.

Disorders from the gastro-intestinal tract

Very often (> 1/10): nausea, irritation of the mouth, throat, tongue and

esophagus.

Often (> 1/100, <1/10): vomiting, diarrhea, a feeling of discomfort in the abdomen,

flatulence, constipation, hiccough. heartburn, dyspepsia.

Breaking from the skin and subcutaneous tissues

Infrequently (> 1/1 000. <1/100): rash.

Common and reaction disorders at the site of administration

Infrequently (> 1 / 1,000, <1/100): increased fatigue, general discomfort, pain in the

breasts.

Frequency unknown: increased sweating.

Overdose:

The minimum lethal dose of nicotine for a person who is not a smoker

is 40-60 mg. For children, the danger even small amounts nicotine, which may be deadly. Suspicion of poisoning child with nicotine is an urgent condition, treatment should be started immediately.

Symptoms

It is assumed that the signs and symptoms an overdose of a nicotine drug

should coincide with those from acute poisoning with nicotine, including pallor skin, cold sweat, increased salivation, nausea, abdominal pain, diarrhea, headache, dizziness, hearing and vision impairment, tremor, confusion and pronounced weakness. In severe cases, these Symptoms may be followed by depression consciousness. lowering of arterial pressure, difficulty breathing, the emergence of fast, weak or irregular pulse, heart failure and convulsions (including terminal convulsions).

Treatment

In case of an overdose (including due to taking an excessive amount of the drug), the patient should immediately seek medical help. The intake of nicotine in the body must be stopped immediately, treatment Overdose nicotine is symptomatic. If necessary should be apply artificial ventilation lungs. The use of activated coal reduces the absorption of nicotine from the gastrointestinal tract.

Interaction:

If you are taking other drugs, before taking the drug "Piquitin® Mini" should be seek medical advice.

Aromatic hydrocarbons contained in tobacco smoke, increase activity microsomal liver enzymes, namely isoenzyme CYP1A2. If you quit smoking, the activity of the isoenzyme CYP1A2 decreases, which may lead to an increase in the concentration of certain medicinal preparations in the blood, metabolized by this isoenzyme. When using drugs with a narrow therapeutic range after quitting, monitoring of clinical and laboratory parameters is required, and it is also necessary to notify the patient about the risk of overdose.

Special instructions:

Rijeka, inherent in nicotine-kneading therapy (H3T), is almost all but less dangerous than the well-known threats associated with continuing smoking.

Cardiovascular disorders

Patients hospitalized for myocardial infarction, cardiac arrhythmias or unstable stroke, it is recommended to quit smoking using non-pharmacological methods. It is possible to administer tablets for resorption "Niquitin® Mini", but the data on safety of its use in this groups of patients are limited, so application should be medical control. When aggravation of cardiovascular reactions It is necessary to reduce the dose of "Niquitin®Mini "or completely stop treatment. PAfter discharge from the treatment institutions patients can resume NRT in normal mode.

Diabetes

Patients with diabetes mellitus, nicotine-replacement therapy, is recommended more often than usual determine the concentration of glucose in blood in connection with the fact that the need for insulin can change, because released by nicotine catecholamines may affect metabolism of carbohydrates.

Allergic reactions

Increased propensity to develop edema Quincke and urticaria.

Qualified medical The employee must correlate the risk and use in patients with listed pathologies:

- Impaired renal and hepatic function: use with caution in patients with hepatic insufficiency of secondary or severe and / or severe renal failure because in these cases, the clearance of nicotine or its metabolites can be reduced, in resulting in undesirable reactions can worsen.

- Pheochromocytoma and uncontrolled hyperthyroidism: apply with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma, since nicotine promotes the release catecholamines.

- Diseases of the gastrointestinal tract tract: orally nicotine can cause an exacerbation symptoms in patients with esophagitis, stomach ulcers or duodenal ulcers guts, so in these cases preparations for oral NZT should be used with caution.

Developed cases of development ulcerative stomatitis.

- Convulsions: In patients receiving anticonvulsant therapy or having a history of epilepsy, the potential risk and benefits of nicotine should be carefully evaluated before use, as nicotine was accompanied by seizures.

Danger of use in young children

Doses of nicotine, carried by adults, can cause severe poisoning in children and even lead to their tornadoes. Preparations containing nicotineshould be kept out of the reach of children.

Non-smoking

Polycyclic aromatic hydrocarbons contained in tobacco smoke, stimulate the metabolism of drugs, catalyzed by CYP1A2 (and, perhaps CYP1A1). Quitting smoking can lead to a slowing of metabolism and an increase in the content of such medicines in the blood. Drug addiction Some people are afraid, after quitting smoking, to become addicted to t nicotine-replacement therapy (NRT). This is extremely rare. but if it happens, cho dependence on NRT is safer than smoking, it is easier to get rid of it.

It is best to completely stop smoking. Smoking is harmful and adversely affects your health. Preparations of NRT, such as "Nikishin Mini", help to quit smoking. Any risks and possible side effects of nicotine from NRT are much less than cigarette smoking.

Form release / dosage:

tablets for resorption [mint] 1.5 mg

tablets for resorption [mint] 4 mg

Packaging:(20) - polypropylene bottles (1) - packings
(20) - polypropylene bottles (3) - packings

Storage conditions:At a temperature not exceeding 25 deg.

Shelf life:3 years

Terms of leave from pharmacies:Without recipe

Registration number:LP-001670

Date of registration:20.04.2012

The owner of the registration certificate: GlaxoSmithClean Consumer Helscher GlaxoSmithClean Consumer Helscher United Kingdom

Manufacturer: & nbsp

GlaxoSmithKline Consumer Healthcare, L.P. USA

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp09.08.2015

Illustrated instructions

Instructions

Niquitin® Mini (Niquitin Mini)