Tabex®® (Tabex®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCytisineCytisine
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  • Tabex®®
    pills inwards 
    Sopharma, AO     Bulgaria
    • Dosage form: & nbsptablets, film-coated.
    Composition:

    Each film-coated tablet contains:

    Active substance: cytisine 1.5 mg.

    Excipients: lactose monohydrate (28.0 mg), microcrystalline cellulose (67.5 mg), talc (2.0 mg), magnesium stearate (1.0 mg) Composition of film coating: fall off II brown 85F 26948 (3.0 mg): partially hydrolysed 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, iron oxide black (E 172) -0.016 mg

    Description:

    Round biconvex tablets covered with a film coat, light brown in color. The appearance of the break is from white to beige.

    Pharmacotherapeutic group:a remedy for the treatment of nicotine addiction.
    ATX: & nbsp

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

    Pharmacodynamics:

    Alkaloid cytisine is an active substance of the drug, has a nholinomimetic effect. Its effects are expressed in the following: it excites the ganglia of the autonomic nervous system, reflexively stimulates respiration, 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 greater 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 tobacco dependence (to facilitate quitting smoking). 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.

    Contraindications:

    Hypersensitivity to the active or any of the excipients of the drug, acute myocardial infarction, unstable angina, cardiac arrhythmia, a recent stroke (within 1 month before the start of the drug), atherosclerosis, severe arterial hypertension, pregnancy and the period of breastfeeding, age 18 years and patients over 65 years of age, lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome (the drug is included

    lactose).

    Carefully: 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 brain vessels, obliterating arterial diseases, hyperthyroidism, gastric ulcer, diabetes, kidney or liver failure, in some forms of schizophrenia, in the presence of chromaffin op Hawley adrenal, 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.
    Pregnancy and lactation:

    Tabeks® should not be used during pregnancy and lactation.

    Dosing and Administration:

    Tablets take inside whole, squeezed 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 - by

    1 tablet 6 times a 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 a day, every 2.5 hours; from 13 to 16 days - 1 tablet 4 times a day, every 3 hours;

    from 17 to 20 day - 1 tablet 3 times a day, every 5 hours;

    from 21 to 25 days - 1-2 tablets a 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, including measures of psychological support of the patient, significantly improves the effectiveness of treatment.

    Side effects:

    Conducted clinical studies and post-marketing observations show a good tolerance of the drug.The observed side effects are mild to moderate. Most of them come at the beginning of treatment, and pass by themselves. Most often they are associated with a refusal of smoking and are manifested by dizziness, headache and insomnia.

    In the recommended doses, the drug Tabex® does not cause serious adverse effects.

    The following side effects are possible:

    - from the cardiovascular system: tachycardia, a slight increase in blood pressure, a feeling of heartbeat;

    - from the central nervous system: headache, dizziness, insomnia or drowsiness, increased

    irritability;

    - from the respiratory system: dyspnea;

    - from the gastrointestinal tract: dry mouth, nausea, abdominal pain, constipation, diarrhea, changes in taste and appetite;

    - from the musculoskeletal and connective tissue: pain in the muscles;

    - from the side of metabolism and nutrition: weight loss, increased sweating;

    - other - pain in the chest.

    Overdose:

    Symptoms of overdose: 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, and 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.

    Interaction:

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

    With the simultaneous use of Tabex ® with acetylcholine, carbachol, galantamine, pyridostigmine, revastigmine, distigmine

    possibly increased cholinomimetic side effects (salivation, lacrimation, bronchial secretion with a cough and the risk of an asthma attack, narrowing of the pupil, colic, nausea, vomiting, frequent urination, increased muscle tone or sudden muscle contractions)

    The use of the drug Tabex® concomitantly with lovastatin, simvastatin, fluvastatin, pravastatin, etc. increases the risk of pain in the muscles.

    Simultaneous use of Tabex® with hypotensive drugs (propranolol and others) can weaken their effect.

    Special instructions:

    The drug should be taken only when 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 ® 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 medicinal preparation contains an auxiliary substance lactose. Patients with rare hereditary problems of galactose intolerance, with lactase deficiency (Lapp type) or glucose-galactose malabsorption should not use the drug.

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

    Although there was no adverse effect on the ability to drive vehicles and work with mechanisms against the background of the drug, however, due to the possible occurrence of drowsiness and other adverse reactions should be used with caution in the listed situations.

    Form release / dosage:

    Tablets, film-coated, 1.5 mg.

    Packaging:

    For 50 tablets, film-coated, in a blister of PVC film / aluminum foil.

    Two blisters in a cardboard liner with a reception calendar along with the instruction for use are placed in a cardboard pack

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children!

    Shelf life:

    2 of the year.

    Do not use after the expiry date printed on the package!

    Terms of leave from pharmacies:Without recipe
    Registration number:П N016219 / 01
    Date of registration:05.02.2010
    The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria
    Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria
    Information update date: & nbsp26.03.2015
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