Tsykotyn IC film-coated tablets 1.5 mg 100 pcs.

• active ingredient: cytisine;
• 1 tablet contains 1.5 mg of cytisine;
• excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose (hydroxypropylmethylcellulose), talc, magnesium stearate, polyethylene glycol (macrogol), titanium dioxide (E 171), iron oxide yellow (E 172).

Hypersensitivity to cytisine or to any of the excipients of the drug, unstable angina, recent myocardial infarction, clinically significant arrhythmias, recent stroke, pregnancy and breastfeeding.

Nervous system: very often – dizziness, irritability, mood swings, anxiety, sleep disorders (insomnia, drowsiness, lethargy, abnormal dreams, nightmares), headache; often – decreased concentration; infrequently – feeling of heaviness in the head, decreased libido.

On the part of the organ of vision: infrequently – lacrimation.

Skin and subcutaneous tissue disorders: very common – rash; uncommon – increased sweating, decreased skin elasticity.

Musculoskeletal and connective tissue disorders: very common – myalgia.

From the cardiovascular system: very often – tachycardia, increased blood pressure; often – bradycardia.

On the part of the gastrointestinal tract: very often – dry mouth, diarrhea, nausea, change in taste, heartburn, constipation, vomiting, abdominal pain (mainly in the upper part); often – bloating, burning of the tongue; infrequently – excessive salivation.

Metabolic and nutritional disorders: very common – change in appetite (mainly increased), weight gain.

Respiratory, thoracic and mediastinal disorders: infrequently – dyspnea, increased sputum production.

General disorders: very common – feeling of weakness; common – malaise; uncommon – increased fatigue.

Research findings: uncommon – increased serum transaminase levels.

Method of application

One package of the medicine (100 tablets) is enough for a full course of treatment.

The duration of the treatment course is 25 days.

The medicine should be taken orally with sufficient water.

The medicine should be used according to the following scheme:

• Days 1-3 – 1 tablet every 2 hours;
• Days 4-12 – 1 tablet every 2.5 hours;
• Days 13-16 – 1 tablet every 3 hours;
• Days 17-20 – 1 tablet every 5 hours;
• Days 21-25 – 1-2 tablets per day.

Smoking should be stopped no later than the 5th day after the start of treatment. If the result of therapy is unsatisfactory, the use of the drug should be discontinued and resumed after 2–3 months.

Patients who have given up smoking should show willpower and not allow themselves to smoke a single cigarette. The duration of the achieved therapeutic effect depends on this.

Use during pregnancy or breastfeeding

There are no clinical data on the use of cytisine in pregnant women.

The results of animal studies are insufficient to assess the reproductive toxicity of cytisine.

The use of the drug during pregnancy is contraindicated.

The use of the drug during breastfeeding is contraindicated.

Children

The drug should not be used in children (under 18 years of age) due to the lack of data on the safety and efficacy of cytisine in this group of patients.

Ability to influence reaction speed when driving vehicles or other mechanisms

Cytisine has no or negligible influence on the ability to drive and use machines.

In case of an overdose of cytisine, symptoms characteristic of nicotine poisoning (nicotine intoxication) are observed.

Symptoms of overdose: malaise, nausea, vomiting, increased heartbeat, fluctuations in blood pressure, respiratory disorders, visual disturbances, clonic convulsions.

Treatment. In all cases of overdose, standard measures should be taken as in the case of acute poisoning; gastric lavage should be performed and diuresis should be controlled with infusion solutions and diuretics. If necessary, anticonvulsants, cardiotonics and analeptics can be used. Respiration, blood pressure and heart rate should be monitored.

Cytisine should not be used concomitantly with anti-tuberculosis drugs. There are no other data on clinically significant interactions of cytisine with other drugs.

Patients should be informed that concomitant use of cytisine and smoking or use of products containing nicotine may lead to increased adverse reactions associated with nicotine.

Hormonal contraceptives

It is currently unknown whether cytisine may reduce the effectiveness of systemic hormonal contraceptives, so women using systemic hormonal contraceptives should use an additional barrier method of contraception.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.