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SPC, UK: ZYBAN Prolonged release tablets (2018)

Therapeutic indications

Zyban tablets are indicated as an aid to smoking cessation in combination with motivational support in nicotine-dependent patients.

Posology and method of administration

Posology

Use in Adults

It is recommended that treatment is started while the patient is still smoking and a “target stop date” set within the first two weeks of treatment with Zyban, preferably in the second week.

The initial dose is 150mg to be taken daily for six days, increasing on day seven to 150mg twice daily.

There should be an interval of at least 8 hours between successive doses.

The maximum single dose must not exceed 150mg and the maximum total daily dose must not exceed 300mg.

Insomnia is a very common adverse event which can be reduced by avoiding bedtime doses of Zyban (provided there is at least 8 hours between doses).

Paediatric population

Use in patients under 18 years of age is not recommended as the safety and efficacy of Zyban tablets have not been evaluated in these patients.

Older people

Zyban should be used with caution in older people. Greater sensitivity in some older individuals cannot be ruled out. The recommended dose in older people is 150mg once a day (see section 4.4).

Patients with hepatic impairment

Zyban should be used with caution in patients with hepatic impairment. Because of increased variability in the pharmacokinetics in patients with mild to moderate impairment the recommended dose in these patients is 150mg once a day.

Patients with renal impairment

Zyban should be used with caution in patients with renal insufficiency. The recommended dose in these patients is 150mg once a day (see section 4.4).

Method of administration

Zyban should be used in accordance with smoking cessation guidelines.

Prescribers should assess the patient’s motivation to quit. Smoking cessation therapies are more likely to succeed in those patients whom are motivated to quit and have motivational support.

Patients should be treated for 7-9 weeks. If at seven weeks no effect is seen, treatment should be discontinued.

Zyban tablets should be swallowed whole. The tablets should not be cut, crushed or chewed as this may lead to an increased risk of adverse effects including seizures.

Zyban can be taken with or without food (see sections 4.5 and 5.2).

Discontinuing therapy

Although discontinuation reactions are not expected with Zyban, a tapering-off period may be considered.

Overdose

Acute ingestion of doses in excess of 10 times the maximum therapeutic dose has been reported. In addition to those events reported as Undesirable Effects, overdose has resulted in symptoms including drowsiness, loss of consciousness and/or ECG changes such as conduction disturbances (including QRS prolongation), arrhythmias and tachycardia. QTc prolongation has also been reported but was generally seen in conjunction with QRS prolongation and increased heart rate. Although most patients recovered without sequelae, deaths associated with bupropion have been reported rarely in patients ingesting large overdoses of the drug.

Treatment

In the event of overdose, hospitalisation is advised. ECG and vital signs should be monitored.

Ensure an adequate airway, oxygenation and ventilation. The use of activated charcoal is recommended. No specific antidote for bupropion is known. Further management should be as clinically indicated.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 25°C. Store in the original package.

Nature and contents of container

Cartons containing cold form foil/foil child-resistant blister packs (PA-Alu-PVC/Paper-Alu).

30, 40, 50, 60 or 100 tablets are supplied in each pack. Each blister strip contains 10 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.