Instruction for use: Tabex

Active substance: Nicotine

ATX Code

N07BA Drugs for treatment of nicotine addiction

Pharmacological group

The agent for the treatment of nicotine dependence [n-Holinomimetiki]

Nosological classification (ICD-10)

F17.2 Nicotine addiction

Link to smoking, Attracted to tobacco smoking, tobacco dependence,Withdrawal symptoms during smoking cessation, Abuse of nicotine

F17.3 abstinent condition caused by tobacco use

nicotine withdrawal,Withdrawal symptoms during smoking cessation

Composition

Tablets, film-coated Table 1.

active substance:

1.5 mg of cytisine

Excipients: lactose monohydrate - 28 mg; MCC - 67.5 mg; Talcum - 2 mg; Magnesium stearate - 1 mg

shell film: Opadry II brown 8 F 26948 - 3 mg: polyvinyl alcohol, partially hydrolyzed - 1.2 mg; titanium dioxide (E171) - 0.654 mg; macrogol 3,350 - 0,606 mg; talc - 0.444 mg; iron oxide yellow (E172) - 0.062 mg, iron oxide red (E172) - 0.018 mg, black iron oxide (E172) - 0.016 mg

The drug forms

Tablets: round, biconvex, film-coated light-brown color.

on the fracture type - from white to beige.

pharmachologic effect

Mode of action - n-cholinomimetic.

Pharmacodynamics

The alkaloid cytisine, which is the active ingredient of the drug, has the n-cholinomimetic action; ons ganglia of the autonomic nervous system, reflex stimulates the respiratory center, causes the release of adrenaline from the adrenal medulla increases blood pressure.

In close similarity to the mechanism of action of nicotine, cytisine possesses much lower toxicity and therapeutic index bólshim.

Tsitizin competitively inhibits the interaction of nicotine with the respective receptors, which leads to a gradual decrease and extinction of nicotine addiction.

Pharmacokinetics

Pharmacokinetic studies have not been conducted in humans.

Indications

Nicotine addiction (to facilitate smoking cessation).

Physical and psychological dependence on nicotine is considered a specific type of the disease, which results in an inability to refrain from smoking, even in understanding its adverse effects.

Contraindications

hypersensitivity to active or any of the excipients of the formulation;

acute myocardial infarction;

unstable angina;

Heart arythmy;

recent myocardial ischemic attack;

atherosclerosis;

severe hypertension;

lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome (lactose is a part of the drug);

pregnancy;

breastfeeding;

age 18 and up to 65 years after.

Precautions: other forms of ischemic heart disease (stable angina pectoris, asymptomatic (silent) ischemia, infarction, vasospastic angina, "X" syndrome (microvascular angina), heart failure, high blood pressure, cerebral vascular disease, obliterating arterial diseases, hyperthyroidism, peptic ulcer disease stomach, diabetes, kidney or liver failure, some forms of schizophrenia, the presence of chromaffin adrenal tumors, gastroesophageal reflux disease, a person with long experience of smoking and people over 40-45 years of age (see "Special instructions".) The use of the drug in patients with diseases. referred to in the "Precautions", is possible only after consulting your doctor.

pregnancy and lactation

Tabex® should not be applied to women during pregnancy and breastfeeding.

Side effects

The drug is generally well tolerated, the observed side effects are mild or moderate. Most of them appear at the beginning of treatment and disappear on their own. Most often they are associated with giving up smoking and appear dizziness, headache and insomnia.

The recommended doses Tabex® drug does not cause serious adverse effects.

The following side effects:

From the CCC: tachycardia, a slight increase in blood pressure, palpitations.

CNS: headache, dizziness, insomnia or drowsiness, irritability.

The respiratory system: dyspnea.

On the part of the digestive tract: dry mouth, nausea, abdominal pain, constipation, diarrhea, changes in taste and appetite.

From the musculoskeletal and connective tissues: muscle pain.

On the part of metabolism and nutrition: weight loss, increased sweating.

Other: pain in the chest.

Interaction

After the cessation of smoking may increase the side effects of theophylline, ropinirole, clozapine and olanzapine.

With the simultaneous use of the drug Tabex® with acetylcholine, carbachol, galantamine, pyridostigmine, rivastigmine, distigminom holinomimeticakih may increase side effects (salivation, lacrimation, bronchial secretion with cough and the risk of an asthma attack, constriction of the pupil, colic, nausea, vomiting, frequent urination, increased muscle tone or sudden muscle contractions).

Application Tabex® drug simultaneously with lovastatin, simvastatin, fluvastatin, pravastatin and others. Increased risk of muscle pain.

The simultaneous use of the drug Tabex® with antihypertensive drugs (propranolol, etc.) Can weaken their effect.

Dosing and Administration

Inside, as a whole, drinking plenty of fluids. Do not exceed the recommended dose. Acceptance of the drug, it is desirable to start after the installation of the patient for a full cessation of smoking.

The drug should be used for the following topologies: c 1 to day 3 - 1 table. 6 times a day (every 2 h), gradually reducing the number of cigarettes smoked. The tablet should be taken between smoking episodes to lengthen the intervals between the smoking of a cigarette, to minimize their consumption. Reception Interval every 2 hours should be observed. If the result is unsatisfactory, treatment should be discontinued, and after 2-3 months, you can start it again.

With good effect of treatment continues as follows: from the 4th to the 12th day - 1 table. every 2.5 hours; from 13 th to 16 th day - on 1 tab. every 3 hours; from 17 th to 20 th day - on 1 tab. every 5 hours; from 21 th to 25 th day - on the table 1-2. in a day.

It is highly recommended to quit smoking no later than the 5th day from the start of treatment. Combination drug therapy with counseling, including with measures of psychological support to the patient, significantly increases the effectiveness of treatment.

Overdose

Symptoms include nausea, vomiting, dilated pupils, weakness, tachycardia, clonic convulsions, respiratory paralysis. It occurs when the patient is not in compliance with the dosing regimen and takes the drug in doses exceeding therapeutic several times.

Treatment: gastric lavage, the appointment of activated carbon, infusional aqueous salt solutions, as well as 5 or 10% glucose solution, the appointment of anticonvulsants, cardiotonics, respiratory analeptikov and other symptomatic treatment. It is necessary to monitor the respiratory system, blood pressure and heart rate.

special instructions

The drug should be initiated only if the patient has a serious intention to quit smoking.

People with long smoking history, and persons aged 40-45 years Tabex® medication should be used only after consulting a doctor. In applying the drug should not exceed the recommended dose. Treatment of drug and continued smoking may lead to increased side effects of nicotine (nicotine intoxication). Medicament excipient comprises lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency with (type Lapp) or glucose-galactose malabsorption should not use the drug.

Influence on the ability to drive vehicles and work with machinery. Although the background of the drug any negative impact on the ability to drive vehicles and work with the mechanisms were not observed, however, due to the possible occurrence of drowsiness and other side effects should be careful in these situations.

Form of issue

Tablets, film-coated, 1.5 mg. The bl. PVC film / aluminum foil, 50 pieces. 2 bl. in a cardboard insert with the calendar in the receiving paper cartons.

Conditions of supply of pharmacies

Without recipe.

Storage conditions

In a dry, dark place at a temperature no higher than 25 ° C.

Keep out of the reach of children.

Shelf-life

2 years.

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