ASMOKEN Tablet Ref.[27972] Active ingredients: Cytisine

Asmoken should be taken only by those with a serious intention of weaning off nicotine. Patient should be aware, that the simultaneous administration of the drug and smoking or use of products containing nicotine could lead to aggravated adverse reactions of nicotine.

Asmoken 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.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, tacrine, clozapine and ropinirole.

The plasma concentration of other medicinal products metabolised in part by CYP1A2 e.g. imipramine, olanzapine, clomipramine and fluvoxamine may also increase on cessation of smoking, although data to support this are lacking and the possible clinical significance of this effect for these drugs is unknown. Limited data indicate that the metabolism of flecainide and pentazocine may also be induced by smoking.

Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal. Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with or without treatment.

History of psychiatric disorders 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.

Women of childbearing potential

Women of childbearing potential must use highly effective contraception while taking Asmoken (see section 4.5 and 4.6).

Asmoken should not be used with anti-tuberculosis drugs. No other clinical data on significant interaction with other drugs.

Patient should be aware, that the simultaneous administration of the drug and smoking or use of products containing nicotine could lead to aggravated adverse reactions of nicotine (see section 4.4).

Hormonal contraceptives

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

Pregnancy

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 (see section 5.3). Asmoken is contraindicated during pregnancy (see section 4.3).

Breastfeeding

Asmoken is contraindicated during breast-feeding (see section 4.3).

Fertility

No data on the effects of Asmoken on fertility.

Women of childbearing potential

Women of childbearing potential must use highly effective contraception while taking Asmoken (see section 4.5 and 4.4). Women using systemically acting hormonal contraceptives should add a second barrier method.

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

The clinical studies and previous experience with use of cytisine-containing product indicate a good tolerability of cytisine. 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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Not applicable.