Tabex tablets, p / o 1.5mg, No. 100

Nicotine addiction (to facilitate smoking cessation).

Physical and psychological addiction to nicotine is considered a specific type of illness that results in the inability to abstain from smoking, even though its negative effects are understood.

The tablets are taken orally whole with a sufficient amount of liquid.

The drug is used according to the following scheme: from 1 to 3 days - 1 tablet 6 times a day, every 2 hours, gradually reducing the number of smoked cigarettes.

If the result is unsatisfactory, the treatment is stopped and after 2-3 months it can be started again. With a good effect, the treatment continues according to the following scheme:
from 4 to 12 days of admission - 1 tablet 5 times a day, every 2.5 hours;
from 13 to 16 days - 1 tablet 3 times a day, every 4 hours;
from 17 to 20 days - 1 tablet 3 times a day, every 5 hours;
from 21 to 25 days - 1-2 tablets per day.
Complete cessation of smoking should occur no later than 5 days from the start of treatment.

Each film-coated tablet contains:
Active ingredient: cytisine 1.5 mg.
Excipients: lactose monohydrate, microcrystalline cellulose, talc, magnesium stearate.
The composition of the film coating: brown opadry II (hypromellose (E464), lactose monohydrate, titanium dioxide (E171), macrogol (macrogol-3000), triacetin, iron dye yellow oxide (E172), iron dye red oxide (E172), iron dye oxide black (E172)).

• Hypersensitivity to the active or any of the excipients of the drug,

• acute myocardial infarction,

• unstable angina,

• Heart arythmy,

• recently suffered cerebrovascular accident,

• atherosclerosis,

• pregnancy and the period of breastfeeding,

• children under 18 and adults over 65,

• deficiency of lactase,

• galactosemia,

• syndrome of glucose-galactose mapabsorption (the drug contains lactose).

With caution
In patients with ischemic heart disease, heart failure, arterial hypertension, cerebrovascular disease, obliterating arterial diseases, hyperthyroidism, gastric ulcer, diabetes mellitus, renal or hepatic failure, some forms of schizophrenia, chromaffin tumors of the adrenal glands, gastroesophageal reflux disease.

Trade name of the drug: TabexЃ

International non-proprietary name or grouping name: cytisine.

Dosage form:

film-coated tablets.

Composition
Each film-coated tablet contains:
Active ingredient: cytisine 1.5 mg.
Excipients: lactose monohydrate, microcrystalline cellulose, talc, magnesium stearate.
The composition of the film coating: brown opadry II (hypromellose (E464), lactose monohydrate, titanium dioxide (E171), macrogol (macrogol-3000), triacetin, iron dye yellow oxide (E172), iron dye red oxide (E172), iron dye oxide black (E172)).

Description
Round biconvex film-coated tablets of light brown color. The view at the break is from white to beige.

Pharmacotherapeutic group:

H-cholinomimetic.

ATX code: [N07BA]

Pharmacological properties

Pharmacodynamics The
alkaloid cytisine is the active substance of the drug, has an H-cholinomimetic effect; stimulates the ganglia of the autonomic nervous system, reflexively stimulates the respiratory center, causes the release of adrenaline from the adrenal medulla, increases blood pressure.
Cytisine has a much lower toxicity and a higher therapeutic index, while its mechanism of action is close to that of nicotine. Cytisine competitively suppresses the interaction of nicotine with the corresponding receptors, which leads to a gradual decrease and disappearance of nicotine addiction.

Indications for use
Nicotine addiction (to facilitate smoking cessation).

Contraindications
Hypersensitivity to the active or any of the excipients of the drug,

• acute myocardial infarction,

• unstable angina,

• Heart arythmy,

• recently suffered cerebrovascular accident,

• atherosclerosis,

• pregnancy and the period of breastfeeding,

• children under 18 and adults over 65,

• deficiency of lactase,

• galactosemia,

• syndrome of glucose-galactose mapabsorption (the drug contains lactose).

With caution
In patients with ischemic heart disease, heart failure, arterial hypertension, cerebrovascular disease, obliterating arterial diseases, hyperthyroidism, gastric ulcer, diabetes mellitus, renal or hepatic failure, some forms of schizophrenia, chromaffin tumors of the adrenal glands, gastroesophageal reflux disease.

Pregnancy and lactation
TabexЃ is not used during pregnancy and during breastfeeding.

Method of administration and dosage
Tablets are taken orally whole with a sufficient amount of liquid. The drug is used according to the following scheme: from 1 to 3 days - 1 tablet 6 times a day, every 2 hours, gradually reducing the number of smoked cigarettes. If the result is unsatisfactory, the treatment is stopped and after 2-3 months it can be started again. With a good effect, the treatment continues according to the following scheme:
from 4 to 12 days of admission - 1 tablet 5 times a day, every 2.5 hours;
from 13 to 16 days - 1 tablet 3 times a day, every 4 hours;
from 17 to 20 days - 1 tablet 3 times a day, every 5 hours;
from 21 to 25 days - 1-2 tablets per day.
Complete cessation of smoking should occur no later than 5 days from the start of treatment.

Side effects
At the beginning of treatment are possible: tachycardia, increased blood pressure, palpitations; headache, dizziness, insomnia or drowsiness, increased irritability; dyspnea; changes in taste and appetite, dry mouth, nausea, abdominal pain, constipation, diarrhea; myalgia; increased sweating, weight loss; chest pain. The drug is usually well tolerated, the observed side effects are mild or moderate. Most of them appear at the beginning of treatment and go away on their own. Most often they are associated with nicotine addiction.

Overdose Overdose
symptoms: nausea, vomiting, dilated pupils, general weakness, tachycardia, clonic convulsions, respiratory paralysis.
Treatment: gastric lavage, infusion of water-salt solutions and 5% or 10% glucose solutions, anticonvulsants, cardiotonics, respiratory analeptics and other symptomatic agents. Respiration, blood pressure and heart rate are monitored.

Interaction with other medicinal products
Cytisine should not be taken simultaneously with anti-tuberculosis drugs because of the risk of increased side effects. With the simultaneous use of TabexЃ with H-cholinomimetics and anticholinesterase drugs, cholinomimetic side effects may increase.

Special instructions
TabexЃ should be prescribed only when the patient has a serious intention to quit smoking. Treatment with the drug and continued smoking can lead to increased side effects of nicotine (nicotine intoxication).
The medicinal product contains an excipient lactose.
Patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or glucose-galactose malabsorption should not use the drug.
TabexЃ does not affect the ability to drive vehicles and work with machines.

Release form and packaging
Film-coated tablets, 1.5 mg.
20 film-coated tablets in a blister of PVC film / aluminum foil.
5 blisters with instructions for use in a cardboard box.

Storage conditions
List A.
In a dry, dark place at a temperature not exceeding 25 ? C. Keep out of the reach of children!

Shelf life is
2 years.
Do not use after the expiry date indicated on the package!

Terms of dispensing from pharmacies: Prescription.

Manufacturer
Sopharma JSC, Bulgaria 1220 Sofia, st. Ilienskoe shosse 16
Representative office of Sopharma JSC in Moscow: 109004, st. Taganskaya, 17-23, floor ten