Cytisine Other names: Baptitoxine Sophorine Cytisinicline

There is no clinical experience of cytisine in patients with renal or hepatic impairment, therefore the drug product is not recommended for use in this patient population.

It is currently unknown whether cytisine may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a second barrier method.

Cytisine should not be used with anti-tuberculosis drugs.

Smoking cessation, with or without pharmacotherapy, has been associated with exacerbation of underlying psychiatric illness (e.g. depression).

Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly.

Citidaron should be taken with caution in case of ischemic heart disease, heart failure, hypertension, pheochromocytoma, atherosclerosis and other peripheral vascular diseases, gastric and duodenal ulcer, gastroesophageal reflux disease, hyperthyroidism, diabetes and schizophrenia.

There are no or limited amount of data from the use of cytisine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Cytisine is contraindicated during pregnancy.

Cytisine is contraindicated during breast-feeding.

Fertility

No data on the effects of cytisine on fertility.

Women of childbearing potential

Women of childbearing potential must use highly effective contraception while taking cytisine. Women using systemically acting hormonal contraceptives should add a second barrier method.

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

The clinical studies and previous experience with use of cytisinicline-containing product indicate a good tolerability of cytisinicline. The proportion of patients who discontinued treatment because adverse reactions was 6-15,5% and in controlled studies it was comparable to the proportion of patients who discontinued treatment in the placebo group. Mild to moderate adverse reactions have usually been observed, most frequently concerning the gastrointestinal tract. The majority of adverse reactions occurred at the beginning of the therapy and resolved during treatment. These symptoms could also be the result of smoking cessation, rather than the use of drug product.

All adverse reactions by system organ class and frequency of occurrence in clinical trials are listed below. The frequency of occurrence is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Metabolism and nutrition disorders

Very common: change in appetite (mainly increase), weight gain

Nervous system disorders

Very common: dizziness, irritability, mood changes, anxiety, sleep disorders (insomnia, drowsiness, lethargy, abnormal dreams, nightmares), headaches

Common: difficulty in concentration

Uncommon: feeling of heaviness in the head, decreased libido

Eye disorders

Uncommon: lacrimation

Cardiac disorders

Very common: tachycardia

Common: slow heart rate

Vascular disorders

Very common: hypertension

Respiratory, thoracic and mediastinal disorders

Uncommon: dyspnea, increased sputum

Gastrointestinal disorders

Very common: dry mouth, diarrhea, nausea, changes flavour, heartburn, constipation, vomiting, abdominal pain (especially in the upper abdomen)

Common: abdominal distension, burning tongue

Uncommon: excessive salivation

Skin and subcutaneous tissue disorders

Very common: rash

Uncommon: sweating, decreased elasticity of the skin

Musculoskeletal and connective tissue disorders

Very common: myalgia

General disorders and administration site conditions

Very common: fatigue

Common: malaise

Uncommon: tiredness

Investigations

Uncommon: increase in serum transaminase levels