Instruction for medical use
name Cytisine Dosage Form Tablet, film coated, 1.5 mg.
One tablet contains
active agent – cytisine (in terms of 100% substance)
excipients: lactoses monohydrate, cellulose microcrystalline (type 102), talc, magnesium stearate.
film cover: the polyvinyl alcohol which is partially hydrolyzed the titan dioxide (E171), a macrogoal 3350, talc, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172).
Round biconvex tablets, film coated beige color, with a diameter of 6 mm.
Drugs for treatment of a disease of nervous system others.
Means for treatment of addictive disorders. Means for treatment of nicotine addiction.
The ATH N07BA code
Tsitizin is easily soaked up in digestive tract at oral administration.
The maximum concentration in blood plasma which makes about 15.55 ng/ml is reached within 0.92 hours.
Cytisine does not undergo considerable metabolic transformation. 64% of the accepted dose are removed in not changed look by kidneys within 24 hours. Elimination half-life makes about 4 hours. The average time of keeping for cytisine is about 6 hours.
Cytisine is alkaloid which is isolated from Cytisus Laburnum plant.
Its chemical structure is similar to nicotine and lobeline. Selectively and kompetitivno contacts N-holinoneyroretseptorami, blocks a possibility of connection with these receptors of nicotine, showing, thus, properties of the antagonist of nicotine. As a result of effect of these drugs, nicotine loses ability to stimulate N-holinoneyroretseptory and to activate a dopamine system the mechanism which is the cornerstone of forming of tobacco addiction (receiving pleasure from nicotine). As a result of this action the symptoms of nicotine addiction gradually decrease and disappear. Other pharmakodinamichesky properties of cytisine: excites a ganglion of the autonomic nervous system, reflex excites breath, causes adrenaline discharge from a medullary part of an adrenal gland, increases anterialny pressure.
the Chronic nicotinism (tabakizm) for refusal of tobacco smoking.
The route of administration and doses
Drug is used according to the following scheme:
from 1 to 3 days – on 1 tablet in 2 hours (6 tablets a day). During these days the gradual reduction of number of the smoked cigarettes is expected. If the result unsatisfactory, treatment stops and in 2-3 months it is possible to start it over again. At good influence the treatment continues according to the following scheme:
from 4 to 12 days on 1 tablet in 2.5 hours (5 tablets a day),
from 13 to 16 days on 1 tablet in 3 hours (4 tablets a day),
from 17 to 20 days on 1 tablet in 5 hours (3 tablets a day),
from 21 to 25 days on 1-2 tablets a day.
Pediatric population and patients is aged more senior than 65 years
Safety and efficiency Tabex at children and 18 years are aged younger than young men and at patients 65 years are more senior are not determined.
The route of administration
of the Tablet is accepted inside whole, washing down with enough liquid.
Final smoking cessation has to happen by fifth day from an initiation of treatment. After completion of treatment course, the patient has to show will and not allow himself smoking of any cigarette.
Treatment duration – according to the scheme.
Side reactions are provided on classes of systems of bodies and frequency. Frequency is provided as follows: very frequent (1/10), frequent (1/100 and & lt, 1/10), infrequent (1/1,000 and & lt, 1/100), rare (1/10,000 and & lt, 1/1,000), very rare (& lt, 1/10,000), observed with an unknown frequency (it is impossible to estimate on the existing data).
Disturbances from heart
With an unknown frequency: tachycardia,
Disturbance palpitations from vessels
With an unknown frequency: easy increase in arterial blood pressure
of Disturbance from nervous system
– a headache *, dizziness *
– an insomnia *, drowsiness *
With an unknown frequency: acrimony
of Disturbance from the respiratory system, bodies of a thorax and mediastinum
With an unknown frequency: dispneya
Disturbances from digestive tract
– pain in an upper part of a stomach *, nausea *, dryness in a mouth *, dyspepsia *
– a konstipation *, diarrhea *, vomiting *
With an unknown frequency: changes of taste and appetite,
the Disturbance abdominal pain from a skeletal muscular system and connective tissue
With an unknown frequency: myalgia
of Disbolism and food
With an unknown frequency: the increased sweating, weight reduction of a body
the General disorders and disturbances in the injection site
With an unknown frequency: thorax pains
* Frequency is calculated on the basis of these 5 randomized klinichnesky studies.
– hypersensitivity to active or to any of excipients
– an acute myocardial infarction
– unstable stenocardia
– heart arrhythmia
– recently postponed cerebrovascular incident
– heavy arterial hypertension
– pregnancy and the period of breastfeeding
– a fluid lungs
– the peptic ulcer of a stomach and duodenum
When smoking is observed increase in activity of CYP1A2. The field of smoking cessation activity of this isoenzyme can be reduced that can cause increase in plasma concentration of medicines which are metabolized with the participation of CYP1A2, such as theophylline, ropinirol, clozapine and olanzapine. In these cases their side effects as these drugs have small therapeutic width can amplify.
At simultaneous use Tabex with cholinomimetics including antikholinesterazny medicines strengthening of cholinomimetic side effects is possible.
Simultaneous use with antigiperlipidemichesky medicines (statines) increases risk of appearance of myalgia.
Simultaneous use Tabex with antihypertensive medicines can weaken their effect.
Tabex it is only necessary to appoint special instructions when at the patient serious intention to refuse tobacco smoking. Drug treatment and continuation of smoking can lead to strengthening of side effects of nicotine (nicotinic intoxication).
Patients do not have a sufficient clinical experience of use Tabex with other forms of coronary heart disease, heart failure, arterial hypertension, vascular and brain diseases, obliterating arterial diseases, a hyper thyroidism, a round ulcer, diabetes, a renal or liver failure. Use Tabex at these patients has to happen after attentive assessment of the attending physician.
In view of lack of researches of safety of drug at patients with some forms of schizophrenia, patients with chromaffin tumors of adrenal glands and a gastroesophageal reflux disease, it is necessary to apply cytisine in similar cases after careful assessment of a ratio advantage/risk.
There is no sufficient clinical experience on the relation of safe use Tabex for children 18 years are younger and at adults 65 years are more senior therefore its use for these age groups is not recommended.
Medicine contains excipient lactose. To patients with rare hereditary problems of intolerance of a galactose, with lactose deficit of Lapp or glyukozo-galaktozny malabsorption it is not necessary to use medicine.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Tabex does not affect ability to drive vehicles and to work with cars.
Symptoms: nausea, vomiting, profuse sweating, tremor, disorder of vision, general weakness, tachycardia, clonic spasms, breath paralysis.
Treatment: gastric lavage if the patient is in consciousness, infusional therapy with saline solutions. Treatment is symptomatic, using means, influencing spasms, disturbances of breath and a cardiovascular system.
Indicators of breath and a cardiovascular system are controlled.
A form of release and packing
On 20 tablets, film coated, in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 5 blister strip packagings together with the instruction for use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in original packing for protection against moisture, at a temperature not higher than 25 wasps.
To store out of children’s reach!
not to accept a period of storage after an expiration date.
JSC SOFARM Producer
St. Iliyenskoye 16th 1220 Highway Sofia, Bulgaria
the Owner of the registration certificate
of JSC SOFARM, Bulgaria
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
JSC Sofarm the Trade mission in Almaty, Kazakhstan, 050036, mdt. Mamyr 4, house 190.
Phone number: 7 (727) 380 01 03, 380 01 37, 380 01 42 (vn. 108)
Fax number: 7 (727) 381 63 86
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