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

Active substance: plaster 7 mg / day contains 36 mg of nicotine, which provides the intake of 7 mg nicotine in the body for 24 hours; the plaster 14 mg / day contains 78 mg of nicotine,that provides the intake of 14 mg nicotine in the body for 24 hours; a plaster of 21 mg / day contains 114 mg of nicotine, which ensures the intake of 21 mg of nicotine in the body for 24 hours. Excipients: pigmented medium density polyethylene / aluminum / polyethylene terephthalate / ethylene vinyl acetate - 52 mg, 111 mg or 163 mg, brown ink PMS 465 (printing ink for marking the sealed liner, not in contact with the skin) - qs, copolymer of ethylene and vinyl acetate (40% vinyl acetate) - 55 mg, 117 mg or 172 mg, high-density polyethylene (film, 30 μm) 20-21 mg, 42-46 mg or 62-67 mg, polyisobutylene-adhesive laminate 133 -141 mg, 281-299 mg or 409-435 mg.

Description:

Niacitin 7 mg / day (7 cm²)

Multilayer patch of rectangular shape, base of pinkish-bronze color with marking NCQ 7, the underside of silvery color, covered with a transparent, removable protective film. The nominal dimensions of the patch are 2.5 cm x 2.8 cm.

Niquitine 14 mg / day (15 cm²)

Multilayer patch of rectangular shape, base of pinkish-bronze color with marking NCQ 14, the underside of silvery color, covered with a transparent, removable protective film. The nominal dimensions of the patch are 3.4 cm x 4.4 cm.

Niquitine 21 mg / day (22 cm²)

Multilayer patch of rectangular shape, base of pinkish-bronze color with marking NCQ 21, the underside of silvery color, covered with a transparent, removable protective film. The nominal dimensions of the patch are 4.65 cm x 4.75 cm.

Pharmacotherapeutic group:a means of treating nicotine addiction (smoking).

ATX: & nbsp

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

N.07.B.A.01 Nicotine

Pharmacodynamics:

Nicotine, the main alkaloid of tobacco, is a substance of natural origin. It is an agonist of the nicotinic receptors of the peripheral and central nervous system, and has a pronounced effect on the central and cardiovascular system. If you quit smoking, dependent smokers may develop withdrawal syndrome, which is accompanied by a characteristic craving for smoking, increased irritability, emotional lability, impaired concentration, anxiety, drowsiness, sleep disturbance, mild somatic disorders (headache, myalgia, constipation, fatigue) and increased appetite and / or weight gain. In some patients, withdrawal symptoms, such as cravings for smoking, can be alleviated by the stable maintenance of a nicotine plasma level lower than smoking.

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 helps to reduce the number of smoked cigarettes for those who can not or do not want to completely quit smoking.

Indications:Nitvitin is indicated to alleviate the symptoms of nicotine withdrawal, including cravings for cigarettes when quitting. If possible, with the refusal to smoke, in parallel with the use of Nykvitina need to change the way of life in a certain way.

Contraindications:

-increased sensitivity to the drug-myocardial infarction in anamnesis (shortly before treatment)

-stable or progressive angina pectoris-Prinzmetal-severe cardiac arrhythmia-recent cerebrovascular disease

Nikvitin plaster should not be used by non-smokers, irregular smokers and children.

Carefully:

When smoking or using an additional source of nicotine during the application of Nyquitine, there is a possibility of side effects as a result of the increase in the level of nicotine,significantly exceeding that only when smoking or using other nicotine drugs. In the case of clinically significant enhancement of reactions from the cardiovascular system or other symptoms associated with the use of nicotine, it is necessary to reduce the dose or to cancel Niquitin. It may also be necessary to adjust the dose of concomitant medications (see "Drug Interactions").

There are reports of the development of tachycardia against the background of applied "Niquitina.

Prior to the application of Nykvitina, a doctor's consultation is mandatory in cases of:

- Cardiovascular diseases (stable angina, heart failure, cerebrovascular diseases, vasospastic diseases, severe peripheral vascular disease),

- Uncontrolled hypertension, because nicotine may be a risk factor for the development of malignant hypertension;

- Atopic or eczematous dermatitis (the probability of local hypersensitivity to the plaster)

- Severe impairment of kidney and liver function, active peptic ulcer

- Hyperthyroidism, pheochromocytoma or insulin-dependent diabetes mellitus.

In case of severe or persistent local reactions at the site of application (expressed erythema, pruritus, edema) or generalized skin reaction (urticaria, rash or generalized skin rash), Nykvitin should be discontinued and consulted by a doctor.

Patients with contact sensitization should be aware of the possibility of developing severe reactions during smoking or the parallel use of other nicotine-containing products.

Pregnancy and lactation:

The harmful effects of nicotine on maternal health and on the fetus are already established. Such effects include: weight loss, increased risk of spontaneous abortion and fetal death in the perinatal period. There are reports of spontaneous abortion during the period of application of Niquitine. Nitvitin can not be excluded from the influence factors. Patients should be advised to quit smoking without using therapeutic nicotine replacement systems, but if they can not, then the risk / benefit ratio of Nyquitine should be assessed.

Dosing and Administration:

Before the start of therapy, the patient It is necessary to come to a solid decision to quit smoking.

In the period of refusal, any attempt smoking can cause a relapse. Therefore, during the course of treatment

smoking is not recommended. Do not do it parallel use of other nicotine-containing products. For

more successful the desired result is recommended appropriate psychological

support.

Adults (including the elderly).

Plaster Nikvitin impose once a day, at the same time, preferably immediately after lifting.

A patch of skin for application plaster should be clean, dry and free of hair. After

application of a patch is necessary for several squeeze the palm tightly. Nikvitin plaster should be applied immediately after removal from the sachet. Do not remove during the day.

The plaster should not be applied to the damaged, reddened or irritated skin. Do not apply to skin folds.

After 24 hours, the used plaster is removed. The new is applied to another area of the skin. Leave the same patch on the skin for more than 24 hours and apply a patch on the same skin area, at least for weeks, it is impossible.

Simultaneously you can impose and wear only one patch.

If desired, the patch can be removed before bedtime.However, to reduce the morning craving for smoking, it is recommended to wear it for 24 hours.

Treatment with nikvitinom begin with 21 mg and lower on the following scheme:

	Dose	Duration
Step 1	Niquitine 21 mg	First 6 weeks
Step 2	Niquitine 14 mg	Next 2 Weeks
Step 3	Nifthin 7 mg	Last 2 weeks

To light smokers (who smokes less than 10 cigarettes a day) is recommended start with 2 stages (14 mg) for 6 weeks and reduce the dose to 7 mg for 2 weeks (8 weeks in total).

When applying Niacitin 21 mg, in case of significant side effects (see "Contraindications") that do not occur for several days, the dosage should be reduced to 14 mg per day. It should be continued until the end of 6 weeks, and then rerun to a dose of 7 mg for 2 weeks. If symptoms persist, consult a physician.

For the best result, a 10-week course of treatment (or 8 weeks for light smokers and patients who have reduced the dose, for the reasons indicated above) should be fully performed.

The maximum duration of treatment - 10 weeks.

Excess of the course is not recommended, due to the risk of developing nicotine addiction or toxic reactions.

In the absence of the desired result or return to smoking, later the course can be repeated.

Side effects:

When applying Niquitine may be side effects similar to such as the introduction of nicotine in

organism by any means, including number and by smoking. They are connected with pharmacological effects

nicotine, some of which are dose-dependent. When application of Niquitine in recommended doses are serious the side effects are registered were not. When applying Nykvitin in doses exceeding recommended, in smokers, which when smoking is not delayingthere is a probability nausea, weakness, and headache.

People who quit smoking (in various ways), can be such manifestations as asthenia, headache, dizziness, sleep disorders, coughing or influenza-like syndrome.

Such reactions as depression, irritability, nervousness, anxiety, volatility

mood, anxiety, drowsiness, weakened concentration, Insomnia can be associated with

withdrawal syndrome due to cessation of smoking.

The most frequent secondary reactions during application Niacitine is a reaction in place

overlay plaster.

The following secondary effects were recorded in clinical trials or

revealed spontaneously.

Side effects of classificationorgan systems and frequency. Frequency of side effects

is defined as follows:

very often (greater than or equal to 1/10), often (greater than or equal to 1/100 and less than 1/10), sometimes (more or

is 1/1000 and less than 1/100), rarely (greater than or equal to 1/10 000 and less 1/1000) and very rarely (more or

is equal to 1/100 000 and less than 1/10 000).

From the immune system:

Sometimes: hypersensitivity. Rarely: anaphylactic reactions

From the side of the psyche:

Often: sleep disorders, including abnormal sleep and insomnia.

Often: nervousness

From the nervous system Often: headache, dizziness

Often: tremor.

From the side of cardiovascular system:

Often: palpitation (palpitation).

Sometimes: tachycardia.

From the respiratory system: Often: shortness of breath, pharyngitis, cough.

From the gastrointestinal side tract:

Often: nausea, vomiting.

Often: dyspepsia, abdominal pain, diarrhea, dry mouth, constipation.

From the skin and subcutaneous Fiber:

Often: increased sweating.

Very rare: . allergic dermatitis, contact dermatitis, photosensitization

From the side of musculoskeletal system:

Often: arlthalgia, myalgia.

Common reactions:

Often: pain in the chest, pain in the chest limbs, pain in place of application plaster, asthenia, fatigue

Sometimes: malaise, influenza-like syndrome.

Local reactions: Very often Adverse reactions in place patching, including

transient rash, itching, burning, tingling, numbness, swelling, pain and urticaria - the most

frequent side effect application Nykvitina.

Most local reactions have a weak expression, and quickly pass after removal

plaster. There may be pain or a feeling of heaviness in the limb or in the place of application of the plaster

(for example, on the chest)

In case of serious and constant local reactions to place of application (eg, erythema,

itching or swelling), or reactions with the body as a whole (eg, urticaria or rash) patient should stop use Nykvitina and consult with a doctor.

In the case of a clinically significant increase in reactions from the cardiovascular system or other reactions,associated with the use of nicotine, the dose of Nyquitine must be reduced or discontinued.

Overdose:

Cases of ingestion or simultaneous use of various dosage forms of Niacitin are unknown.

Symptoms of an overdose of Nitwitin are the same as those of nicotine poisoning: pallor, cold sweat, nausea, salivation, vomiting, abdominal pain, diarrhea, headache, dizziness, hearing and vision impairment, tremor, weakness, confusion, hypotension. In case of an overdose with a large dose of nicotine, prostration, convulsions, severe breathing disorders and, in rare cases, cardiovascular activity, arterial hypotension are possible.

Treatment of overdose with local application In case of an overdose or

symptoms of overdose immediately remove the adhesive.

It is necessary to apply immediately for medical help. Plot of land skin on which

remove the patch with water and wipe. Do not use soap, because it can enhance absorption

nicotine. It should be borne in mind that Absorption of nicotine into the blood will be continue for several

hours after removal of the plaster, because the skin formed a depot.

Treatment of overdose in swallowing When the plaster is swallowed

patient should be given activated carbon, since the isolation of nicotine in the gastro-intestinal tract will continue for another several hours. Refer to the doctor.

Treatment of nicotine poisoning Symptomatic therapy includes the appointment of diazepam or barbiturates, for cramping seizures, atropine for the prevention of bronchial hypersecretion and diarrhea, respiratory analeptics and transfusion of a sufficient amount of fluid, for the prevention of arterial hypotension and collapse.

Interaction:

Special instructions:

Children

Data on the safety and efficacy of the drug in children and adolescents-smokers do not. The use of nikvitina in children is not recommended. Use in adolescents (aged 12-17 years) is possible only after consulting a doctor.

The amount of nicotine, which is well tolerated by adult smokers, can cause poisoning, even fatal, when used in children, including accidental.Even after use, the patches contain a sufficient amount of nicotine to cause adverse effects on the health of children. The drug should be stored only inplaces inaccessible to children. Renal failure.

The drug should be used with caution in patients with severe and moderate severity of kidney failure, since the clearance of nicotine or its metabolites can be reduced, potentially increasing the risk of side effects.

Liver failure The drug should be used with caution in patients with severe and moderate hepatic impairment, since the clearance of nicotine or its metabolites may be reduced, potentially increasing the risk of side effects.

Diabetes:

Regardless of the use of NRT during the quitting period, the blood glucose limits may be more variable, so it is very important that patients with diabetes continue to monitor blood sugar levels using the Nikvitin plaster. Patients hospitalized for myocardial infarction, severe arrhythmia or stroke with unstable hemodynamic parameters it is better to use non-pharmacological methods of quitting smoking.

In the absence of a result, the possibility of using Nikvitin patch may be considered, but due to the limited data on the safety of the drug in this group of patients, therapy should be initiated only under the supervision of a physician. After discharge, patients can apply NRT on their own.

In the case of a clinically significant increase in cardiovascular reactions or other symptoms associated with the use of nicotine, it is necessary to reduce the dose or cancel Nykvitin

If redness, swelling of the skin or the appearance of rashes that do not occur within 4 days, or with generalized skin reactions, it is necessary to stop using the drug and seek consultation with a doctor. The probability of these reactions is higher in patients with a history of dermatitis. Avoid contact with eyes and nose. After application, it is necessary to wash hands only with water, since soap can enhance the absorption of nicotine.

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

Nitvitin does not affect the ability to drive a car and use sophisticated technology.

Form release / dosage:

Plaster (transdermal therapeutic system). One patch is placed in a bag of laminate.7 or 14 patches are placed in a cardboard box together with instructions for use.

Packaging:transdermal therapeutic system, 7 mg / day, 14 mg / day, 21 mg / day (sachet) 7/14 × 1 (cardboard box)

Storage conditions:Store at a temperature not exceeding 25 ° C in a place inaccessible to children.

Shelf life:

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

Terms of leave from pharmacies:Without recipe

Registration number:П N011315 / 01

Date of registration:08.04.2009

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

Manufacturer: & nbsp

GlaxoSmithKline Dungarvan, Ltd. Ireland

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp12.08.2015

Illustrated instructions

Instructions

Niquitin® (Niquitin)