International generic name (More at www.tabex.net)

Cytisine

Drug form and composition

Film-coated tablets. One film-coated tablet contains 1.5 mg Cytisine.

Indications

Smoking cessation in smokers.

Dosage and administration

The product is used orally according to a scheme: first 3 days 1 tablet 6 times daily (at an interval of 2 hours) associated with reduction in number of the cigarettes used. In cases of good effect the treatment continues according to the following scheme: day 4 to 12 - 1 tablet at an interval of 2.5 hours (5 tablets daily); day 13 to 16 - 1 tablet at an interval of 3 hours (4 tablets daily); days 17 to 20 - 1 tablet at an interval of 5 hours (3 tablets daily); days 21 to 25 - 1 to 2 tablets daily. Smoking should be stopped approximately at day 5 after the beginning of the treatment.

Contraindications

Tabex is contraindicated in hypertensive patients, severe atherosclerosis, pregnancy, and lactation.

Special warnings and precautions

Tabex should be used only in patients, which seriously intend to stop smoking. The patient must be warned that Tabex use together with persisting smoking can lead to increased adverse nicotine effects. In patients suffering from ischemic heart disease, heart failure, cerebrovascular diseases, arterial diseases with obliteration, hyperthyroidism, diabetes, renal and hepatic failure, Tabex should be used after careful assessment by the physician.

Drug interactions

There are no data for any clinically significant drug interactions of Tabex with other drugs.

Adverse reactions

The most frequent adverse reactions after the beginning of the treatment using Tabex are: changes in taste and appetite, dry mouth, headache, increased irritability, nausea, constipation, tachycardia, slightly elevated blood pressure. These reactions disappear during the treatment.

Pharmacological mechanisms

Tabex has been created using the plant cytisine, which is an alkaloid with N-cholinomimetic action. Cytisine stimulates the autonomic nerve ganglia and by a reflex pathway stimulates breathing, induces release of epinephrine form the suprarenal glands and elevates blood pressure. The aim when using Tabex is to replace nicotine, entering in the body during smocking, by cytisine taken orally. The mechanism of the cytisine action is similar to nicotine. Because of this fact gradual cessation of smocking can be achieved and abstinence is avoided.

Supplied

100 film-coated tablets of 1.5 mg.

Expiry

2 years