Tabeks tab n / a film about 100 pieces

Description

Composition
Active substance:
1.5 mg of cytisine.
Excipients:
Lactose monohydrate (28.0 mg), microcrystalline cellulose (67.5 mg), talc (2.0 mg), magnesium stearate (1.0 mg).
Composition of film coating: Opadry II 85F 26948 brown (3.0 mg): partially hydrolyzed polyvinyl alcohol – 1.2 mg; titanium dioxide (E 171) – 0.654 mg; Macrogol 3350 – 0,606 mg; talc – 0.444 mg; iron oxide yellow (E 172) – 0.062 mg iron oxide red (E 172) – 0.018 mg, black iron oxide (E 172) – 0.016 mg.
Description:
Round biconvex tablets, film-coated, light brown. Kind of on a break – from white to beige.
Product form:
Tablets, film-coated, 1.5 mg.
50 tablets, film-coated in PVC blister film / aluminum foil.
2 in the blister cardboard insert receiving calendar together with instructions for use placed into cardboard pack.
Contraindications
Hypersensitivity to active or any of the excipients of the drug, acute myocardial infarction, unstable angina, cardiac arrhythmia, recent stroke (within one month before the start of the drug), atherosclerosis, severe hypertension, pregnancy and lactation, age 18 years and patients older than 65 years, the lack of laktazy, galactosemia, a syndrome of glucose-galactose malabsorption (lactose included in the drug).
Precautions: Tabeks® drug should be used in other forms of coronary artery disease (stable angina pectoris, asymptomatic (silent) myocardial ischemia, vasospastic angina, “X” syndrome (microvascular angina)), heart failure, high blood pressure, diseases of the cerebral vessels brain, obliterating arterial diseases, hyperthyroidism, gastric ulcer, diabetes, kidney or liver failure, in some forms of schizophrenia, in the presence of ii chromaffin adrenal tumors, gastroesophageal reflux disease, persons with long smoking history, and persons aged 40 – 45 years of age (see “Special Instructions”.).
Use of the drug in patients with diseases specified in the “Caution” is possible only after consulting your doctor.
Indications
Treatment of tobacco dependence (to facilitate smoking cessation). Physical and psychological addiction to nicotine is considered to be a certain type of disease that leads to an inability to abstain from smoking, even in understanding its adverse effects.
Interaction with other drugs
After the cessation of smoking may increase the side effects of theophylline, ropinirole, clozapine and olanzapine. With the simultaneous use of the drug Tabeks® with acetylcholine, carbachol, galantamine, pyridostigmine, revastigminom, distigminom holinomimeticakih may increase side effects (salivation, lacrimation, bronchial secretion with cough and the risk of an asthma attack, constriction of the pupil, cramps, nausea, vomiting, frequent urination, increased muscle tone or sudden muscle contractions).
Use of the drug simultaneously Tabeks® c lovastatin, simvastatin, fluvastatin, pravastatin and others. Increased risk of muscle pain.
Simultaneous use of the drug Tabeks® with antihypertensive agents (propranolol et al.) Can weaken their effect.
Overdose
Symptoms of overdose include nausea, vomiting, dilated pupils, weakness, tachycardia, clonic convulsions, respiratory paralysis.
Overdose symptoms occur when the patient is not in compliance with the dosing regimen and takes the drug in doses several times higher than therapeutic.
In case of overdose you should immediately consult a doctor!
Treatment: administration of activated charcoal, gastric lavage, infuzionnoevvedenie aqueous salt solutions, as well as 5% or 10% glucose solution, anticonvulsants, cardiotonic, analeptic respiratory and other symptomatic agents. It should keep track of the breathing organs, blood pressure and heart rate.
pharmachologic effect
Pharmacological group:
agent for the treatment of nicotine addiction.
Pharmacodynamics:
Alkaloid cytisine is an active drug substance, has n-cholinomimetic activity. Its effects are expressed as follows: excites ganglia of the autonomic nervous system, reflexively stimulates respiration, 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 a large therapeutic index. Cytisine competitively inhibits the interaction of nicotine to the corresponding receptors, which leads to a gradual reduction and disappearance of nicotine (tobacco) dependence.
Pharmacokinetics:
Pharmacokinetic parameters cytisine investigated in 36 healthy volunteers after a single oral dose of 1.5 mg (1 tablet Tabeks®).
Suction
Cytisine is rapidly absorbed from the gastrointestinal tract after oral administration. The maximum concentration of drug in blood plasma of 15.55 ng / ml achieved for 0.92 hours.
Distribution
Clinical data on the distribution of the drug are no people.
In mice, high plasma concentration of cytisine after oral and intravenous administration set in the liver, kidney and adrenal glands. The volume of distribution (Vd) in rabbits after oral and intravenous administration of 6.21 L / kg, respectively, and 1.02 l / kg.
Biotransformation and excretion
Cytisine is not metabolized in the body. Up to 64% of the applied dose is excreted unchanged in the urine within 24 hours. The half-life is about 4 hours. The mean retention time (MRT) of cytisine in the body is about 6 hours.
Pregnancy and breast-feeding
Tabeks® should not be used during pregnancy and lactation.
Conditions of supply of pharmacies
Without recipe.
side effects
Clinical studies and post-marketing observations have shown good tolerability. The observed side effects are mild or moderate. Most of them occur at the beginning of treatment and disappear on their own. Most often they are associated with smoking cessation and are manifested by dizziness, headache and insomnia.
In the recommended doses, the drug Tabeks® no serious adverse effects.
Possible side effects:
– the part of the cardiovascular system: tachycardia, a slight increase in blood pressure, palpitations;
– Central nervous system: headache, dizziness, insomnia or drowsiness, irritability;
– Respiratory system: shortness of breath;
– on the part of the gastrointestinal tract: dry mouth, nausea, abdominal pain, constipation, diarrhea, changes in taste and appetite;
– on the part of the musculoskeletal and connective tissue disorders: muscle pain;
– the part of metabolism and nutrition: weight loss, increased sweating;
– Other – pain in the chest.
special instructions
The drug should be initiated only if the patient has a serious intention to give up smoking.
Persons with long experience of smoking, and people older than 40 – 45 years Tabeks® drug should be used only after consulting a doctor.
In applying the drug should not exceed the recommended dose.
drug treatment 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.
Effects on ability to drive vehicles and operate machinery:
Although the background of the preparation of any negative impact on the ability to drive vehicles and operate machinery have not been observed, however, due to the possible occurrence of drowsiness and other side effects should be careful in these situations.
Storage conditions
In a dry, dark place at a temperature not higher than 25 ° C.
Keep out of the reach of children!
Dosing and Administration
Tablets are inside integers, 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 preparation should be applied in the following way: 1 to 3 day – 1 tablet 6 times a day, every 2 hours gradually reducing the number of cigarettes smoked. Tablets should be taken between smoking episodes to lengthen the intervals between the smoking of a cigarette to minimize their consumption. Receiving interval every 2 hours should be observed.
If you are unable to reduce the daily consumption of cigarettes, treatment should be discontinued, and after 2-3 months, you can start it again.
With good effect of treatment continues as follows:
from 4 to 12 day of admission – 1 tablet 5 times a day, every 2.5 hours;
13 to 16 day – 1 tablet 4 times a day, every 3 chasa;
from 17 to 20 day – 1 tablet 3 times a day, every 5 hours;
21 to 25 day – 1-2 tablets a day.
It is highly recommended to quit smoking no later than 5 days from the start of treatment.
The combination drug therapy with counseling, including measures of psychological support for patients, significantly increases the effectiveness of treatment.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist