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

Active Ingredient: nicotine - 10 mg (4 mg of the released substance) Excipients: levomenthol - 1 mg, ethanol * - 133 mg, nitrogen - q.s., porous cylinder - 1 piece.

* - evaporates in the production process.

Description:

Nicotine inhaler is a white or slightly colored porous cylinder in a sealed, transparent, plastic cartridge with an inscription "NICORETTE" and the specified number of the series.

Pharmacotherapeutic group:a remedy for the treatment of nicotine addiction.

ATX: & nbsp

N.07.B.A Drugs used in nicotine addiction

N.07.B.A.01 Nicotine

Pharmacodynamics:

Indications:

For the treatment of tobacco dependence by reducing the need for nicotine, the withdrawal of withdrawal symptoms arising with complete quitting from those who decided to quit smoking; facilitates temporary abstinence from smoking, and also helps to reduce the number of smoked cigarettes for those who can not or do not want to completely quit smoking.

Contraindications:

Hypersensitivity to nicotine or other components that make up the inhaler. Recently suffered myocardial infarction (in the previous 3 months). Unstable or progressive angina, variant angina pectoris (Prinzmetal angina). Severe arrhythmias. Acute phase of a stroke.

Carefully:

The nicorette® inhaler should be used with caution in patients with severe cardiovascular disease (peripheral arterial occlusive disease, cerebral vascular disease, stable angina and heart failure during decompensation), vasospasm, uncontrolled hypertension, severe / moderate liver disease, severe kidney diseases, peptic ulcer of the stomach and duodenum in the acute stage, chronic diseases of the pharynx and asthma.

Nicotine, which enters the body both with substitution therapy with nicotine-containing drugs, and during smoking, causes adrenal release of catecholamines. Therefore, the nicorette® inhaler should be used with caution by patients with hyperthyroidism or pheochromocytoma.

The Nicorette® inhaler should not be used by persons under the age of 18 without a doctor's prescription. The experience of using the nicorette® inhaler with adolescents under the age of 18 is not available.

Pregnancy and lactation:

Nicotine penetrates the placental barrier and affects the respiratory activity and blood circulation of the fetus.At the same time, the effect on blood circulation is dose-dependent. Besides, nicotine is released with milk and can have a harmful effect on the newborn, even when taken in therapeutic doses.

In this regard, smoking women during pregnancy and feeding should use the nicorette® inhaler only after consulting a doctor. Smoking can cause serious harm to the fetus and the newborn, so smoking pregnant women should be advised to completely stop smoking without using substitution therapy with nicotine-containing medications. The effect of the Nicorette® inhaler on children has not been fully studied.

Dosing and Administration:

The nicorette® inhaler should be inhaled at the time when there is an irresistible desire to smoke. Dosage is selected individually, taking into account the degree of severity of the patient's nicotine addiction. However, do not use more than 12 cartridges per day. Such a full dose can be used for 6-12 weeks, after which you should start gradually wean from nicotine.

When you quit smoking, the flow of nicotine into the body stops; at the same time you can develop various kinds of unpleasant sensations - the so-called withdrawal symptoms. With the aid of an inhaler nikorette® you can prevent or at least minimize these symptoms, while continuing to inhale small amounts of nicotine. When air is inhaled through an inhaler, nicotine evaporates and is absorbed into the oral cavity. Absorption of nicotine is slow, and high concentrations of nicotine in the plasma can not be created quickly, as is the case with tobacco smoking. In addition, unlike cigarettes, nicorette® inhaler does not contain tar and carbon monoxide.

Adult patients, including elderly patients

The more often an inhaler is used, the easier it is to quit smoking for a long time. One cartridge replaces 4 cigarettes. If you smoked 20 cigarettes a day, you should use 6 cartridges per day. Each cartridge can be used in about 4 doses, each lasting about 20 minutes. The recommended dose is 6-12 cartridges per day.

Full cessation of smoking

Use the inhaler for at least 3 months. Then you should start to gradually reduce the number of used cartridges. It is recommended to have a few additional cartridges with you, as there may be an unexpected desire to smoke.

Reducing the number of cigarettes smoked

Use the inhaler during breaks between smoking to increase their duration and for the maximum possible reduction in the number of cigarettes smoked. If after 6 weeks the number of cigarettes smoked per day is not reduced, you should consult a specialist.

Try to stop smoking when you are ready for it, but not later than 6 months after the start of treatment. If within 9 months after the beginning of treatment you did not manage to quit smoking, you should consult a specialist.

As a rule, it is not recommended to use the inhaler for more than 6 months. Some patients who quit smoking require a longer use of the inhaler to prevent a return to smoking.

Consultations of a specialist and psychological support contribute to the effectiveness of therapy.

Instructions for use

Remove the mouthpiece from the plastic container. Align the marks and remove the upper half of the mouthpiece.

Remove the blister. Remove one cartridge from the printer. After inserting the cartridge into the mouthpiece, push it towards the bottom of the mouthpiece with sufficient force so that the protective coating (aluminum bridge) on the bottom of the cartridge ruptures. Return the upper half of the mouthpiece to its original position.Align the marks again and squeeze the top and bottom of the mouthpiece towards each other so that this time the upper jumper of the cartridge ruptures. Rotate the top or bottom of the mouthpiece slightly around the axis to achieve a displacement of the marks relative to each other - your mouthpiece is closed.

Place the blister with the remaining cartridges back into the plastic container and close it.

The nicorette® inhaler is now ready for use. After opening the protective coating, the concentration of nicotine in the cartridge decreases rapidly. Therefore, it should be used as soon as possible. Do not use open cartridges the next day.

After use, remove the cartridge from the mouthpiece. The used cartridge should be discarded. The mouthpiece should be stored in a container.

Side effects:

The use of nicorette® inhaler can be accompanied by the development of the same side effects as with the use of nicotine in other forms. The severity of side effects depends on the accepted dose of nicotine. Approximately 40% of cases develop minor local reactions, such as coughing and irritation of the oral and pharyngeal mucosa.Most of the side effects observed in patients develop within the first weeks after the start of treatment.

Frequently noted side effects (>1/100)

- Headache.

- Unpleasant sensations from the gastrointestinal tract, hiccough, nausea, vomiting.

- Cough.

- Irritation of the mucous membrane of the oral cavity and pharynx, nasal congestion.

Less common (1/100 - 1/1000)

Cardiopalmus.

Rare (< 1/10001

Paroxysmal atrial fibrillation.

Such side effects as dizziness, headache, insomnia and anxiety can be manifestations of withdrawal symptoms caused by quitting. If you quit smoking, you can also increase the incidence of aphthous ulcers, the cause of which is not known.

Overdose:

In case of an overdose, the same symptoms are noted as with acute nicotine poisoning, namely: nausea, salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing loss and marked general weakness. When high doses enter the body, hypotension, a weak and non-rhythmic pulse, respiratory depression, respiratory center paralysis, prostration, vascular collapse and generalized convulsions may be added to the above symptoms.

Doses of nicotine, which are well tolerated during treatment by adult smokers, can cause symptoms of severe poisoning in young children, and even lead to death.

Treatment

You should immediately stop taking nicotine and begin symptomatic treatment. The intake of activated carbon prevents the absorption of nicotine in the gastrointestinal tract.

Interaction:

After quitting smoking, it is possible to increase the level in the blood plasma of certain medicines that are of important clinical importance and are characterized by a narrow "safety corridor", such as theophylline, tacrine and clozapine, and imipramine, olanzapine, clomipramine and fluvoxamine.

In addition, there are some indications of a possible stimulating effect of smoking on the metabolism of flecainide and pentazokine.

Special instructions:

Patients suffering from diabetes, due to quitting smoking, may need to reduce the dose of insulin.

There may be a development of transitional nicotine dependence, however, the use of pure nicotine causes less harm than the use of tobacco.

When swallowed, chewed, or sucked a nicotine cartridge (both used and unused), children are at risk of poisoning. Note that at low temperatures, the effectiveness of the nicotete® inhaler is reduced. Therefore, the inhaler should be used at temperatures above + 15 ° C.

The nicorette® inhaler is an effective adjuvant, but remember that the ultimate success depends on the firmness of your decision to quit.

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

Form release / dosage:

Solution for inhalation [absorbed] 10 mg

For 10 mg of nicotine in the inhaler; 6 inhalers are placed in a blister;

- 1 blister, 1 mouthpiece in a transparent plastic film, 1 plastic container with an inscription "nicorette®" and instructions for use in a cardboard box;

- 7 blisters, 1 mouthpiece in a transparent plastic film, 1 plastic container with an inscription "nicorette®" and instructions for use in a cardboard box;

- 3 blisters, 1 mouthpiece in a transparent polymer film and instructions for use in a cardboard box;

- 7 blisters, 1 mouthpiece in a transparent polymer film and instructions for use in a cardboard box.

Packaging:1) - sachets (14) - packs of cardboard
(1) - sachets (7) - packs of cardboard

Storage conditions:

At a temperature not higher than + 25 ° C, out of the reach of children.

When you do not use the Nicorette® inhaler, store it in a sealed plastic container.

Shelf life:

3 years.

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

Note:

The marking of the expiry date on the package (the period from the production date to the date specified in the item "go to") may be less than 3 years for 1 month.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001024

Date of registration:03.08.2010

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)