Composition, form of production and packaging
? The tablets covered with a film membrane of light brown color, round, biconcave; The appearance at the break is from white to beige.
1 tab.
cytisine 1.5 mg
[PRING] lactose monohydrate - 28 mg, microcrystalline cellulose - 67.5 mg, talc - 2 mg, magnesium stearate - 1 mg.
The composition of the film shell: opadraj II brown 85F26948 - 3 mg (polyvinyl alcohol partially hydrolyzed 1.2 mg, titanium dioxide (E171) 0.654 mg, macrogol 3350 0.606 mg, talc 0.444 mg, iron oxide yellow (E172) 0.062 mg, iron oxide red (E172) - 0.018 mg, iron oxide black (E172) - 0.016 mg).
50 pcs. - Blisters (2), enclosed in a cardboard insert with a calendar of reception - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
The drug for the treatment of nicotine addiction, n-holinomimetik. The alkaloid cytisine is an active substance of the drug, it has an n-cholinomimetic effect. Its effects are expressed in the following: it excites the ganglia of the autonomic nervous system, reflexively stimulates breathing, causes adrenaline release from the adrenal medulla, raises blood pressure.
With a close resemblance to the mechanism of action of nicotine, cytisine has a much lower toxicity and a wider therapeutic index. Cytisine competitively suppresses the interaction of nicotine with the corresponding receptors, which leads to a gradual decrease and disappearance of nicotine (tobacco) dependence.
PHARMACOKINETICS
Pharmacokinetic studies in humans have not been conducted.
INDICATIONS
- treatment of nicotine addiction (to facilitate quitting).
Physical and psychological dependence on nicotine is considered a specific type of disease, which leads to the inability to abstain from smoking, even with an understanding of its negative effects.
DOSING MODE
Tablets are taken internally with a sufficient amount of liquid.
Do not exceed recommended doses.
It is advisable to start taking the drug after the patient has been placed on a complete cessation of smoking.
The drug should be used according to the following scheme: from 1 to 3 days - 1 tablet 6 times / day every 2 hours, gradually reducing the number of cigarettes smoked.
The tablet should be taken between episodes of smoking to extend the intervals between cigarette smoking in order to minimize their consumption. The interval of reception every 2 hours should be observed.
If you can not achieve a decrease in daily cigarette consumption, treatment should be discontinued and after 2-3 months you can start it again.
With a good effect, the treatment is continued according to the following scheme:
from 4 to 12 days of administration - 1 tablet 5 times / day, every 2.5 hours;
from 13 to 16 days - 1 tablet 4 times / day, every 3 hours;
from 17 to 20 day - 1 tablet 3 times / day, every 5 hours;
from 21 to 25 days - 1-2 tablets per day.
It is strongly recommended that you quit smoking no later than 5 days after the start of treatment.
Combination of drug therapy with consultations, incl. with measures of psychological support of the patient, significantly increases the effectiveness of treatment.
SIDE EFFECT
Conducted clinical studies and post-marketing observations show a good tolerance of the drug. The observed adverse reactions are mild or moderate. Most of them come at the beginning of treatment, and pass by themselves. Most often, they are associated with the refusal of smoking and are manifested by dizziness, headache and insomnia.
In the recommended doses, the drug Tabex В® does not cause serious adverse effects.
The following adverse reactions are possible.
On the side of the cardiovascular system: tachycardia, a slight increase in blood pressure, a feeling of heartbeat.
From the side of the central nervous system: headache, dizziness, insomnia or drowsiness, increased irritability.
From the respiratory system: shortness of breath.
From the gastrointestinal tract: dry mouth, nausea, abdominal pain, constipation, diarrhea, changes in taste and appetite.
From the osteomuscular and connective tissue: pain in the muscles.
From the side of metabolism and nutrition: weight loss, increased sweating.
Other: pain in the chest.
CONTRAINDICATIONS
- hypersensitivity to the active or any of the excipients of the drug;
acute myocardial infarction;
- unstable angina;
- Heart arythmy;
- a recent stroke (within 1 month before starting the drug);
- Atherosclerosis;
- severe arterial hypertension;
- Pregnancy;
- the period of breastfeeding;
- age up to 18 years;
- Patients over 65 years of age;
- Lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome (lactose is included in the formulation).
With caution should be used drug Tabex В® in other forms of ischemic heart disease (stable angina, asymptomatic (silent) myocardial ischemia, vasospastic angina, syndrome "X" (microvascular angina)), with heart failure, high blood pressure, with diseases of the cerebral vessels, obliterating arterial diseases, hyperthyroidism, gastric ulcer, diabetes mellitus, renal or hepatic insufficiency, with some forms of schizophrenia, in the presence of chromaffin adrenal tumors, gastras oesophageal reflux disease, people with a long history of smoking and people older than 40-45 years. The use of the drug in patients with the diseases listed in the section "With caution" is possible only after consulting a doctor.
PREGNANCY AND LACTATION
Tabex В® should not be used by women during pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution appoint a drug for kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution appoint a drug for liver failure.
SPECIAL INSTRUCTIONS
The drug should be used only if the patient has a serious intention to quit smoking.
Persons with a long history of smoking and people older than 40-45 years of drug Tabex В® should be used only after consulting a doctor.
When using the drug, do not exceed recommended doses.
Treatment with the drug and continued smoking can lead to increased side effects of nicotine (nicotine intoxication).
The preparation contains an auxiliary substance lactose. Patients with rare hereditary problems of galactose intolerance, with lactase deficiency (Lapp) or glucose-galactose malabsorption should not be used Tabex В® .
Impact on the ability to drive vehicles and mechanisms
Although there was no adverse effect on the ability to drive vehicles and work with the mechanisms against the background of the drug, due to the possible occurrence of drowsiness and other adverse reactions, care should be taken in the listed situations.
OVERDOSE
Symptoms: nausea, vomiting, dilated pupils, general weakness, tachycardia, clonic convulsions, respiratory paralysis. Symptoms of overdose occur when the patient does not comply with the dosing regimen and takes the drug at doses several times higher than the therapeutic dose.
If an overdose occurs, seek medical advice immediately!
Treatment: reception of activated carbon, gastric lavage, infusion of aqueous-saline solutions, as well as 5% or 10% glucose solution, anticonvulsants, cardiotonics, respiratory analeptics and other symptomatic agents. The work of the respiratory system, blood pressure and heart rate should be monitored .
DRUG INTERACTION
After smoking cessation, the side effects of theophylline, ropinirole, clozapine and olanzapine may be exacerbated.
With the simultaneous use of Tabex В® with acetylcholine, carbachol, galantamine, pyridostigmine, rivastigmine, distigmine, cholinomimetic side effects (salivation, lacrimation, bronchial secretion with cough and the risk of an asthma attack, pupil narrowing, colic, nausea, vomiting, frequent urination, increased muscle tone or sudden muscle contractions).
The use of the drug Tabex В® concomitantly with lovastatin, simvastatin, fluvastatin, pravastatin, etc. increases the risk of pain in the muscles.
The simultaneous use of Tabex В® with hypotensive drugs (propranolol, etc.) can weaken their effect.
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, dark place at a temperature of no higher than 25 В° C. Shelf life - 2 years.
Keep out of the reach of children.
