WELLBUTRIN SR TABLETS 150 mg

TABLET, FILM COATED

**Dosage and Administration** Pharmaceutical form: Sustained-release (SR) film-coated tablet. _WELLBUTRIN SR_ 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. Studies suggest that exposure to bupropion may be increased when sustained-release bupropion tablets are taken with food (see _Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Use in adults** The maximum single dose of _WELLBUTRIN SR_ is 150 mg. _WELLBUTRIN SR_ tablets should be taken twice daily with an interval of at least 8 hours between successive doses. Insomnia is a very common adverse event which is often transient. Insomnia may be reduced by avoiding dosing at bedtime (provided there is at least 8 hours between doses) or, if clinically indicated, dose reduction may be considered. Initial treatment Dosing with _WELLBUTRIN SR_ tablets should begin at 150 mg/day given as a single daily dose in the morning. If the 150 mg initial dose is adequately tolerated, patients who are not responding adequately may benefit from an increase to 300 mg/day, given as 150 mg twice daily, after an interval of at least one week. There should be an interval of at least 8 hours between successive doses. The maximum daily dose should not exceed 300 mg/day. Maintenance therapy It is generally agreed that acute episodes of depression require 6 months or longer of antidepressant drug treatment. **Use in children and adolescents** _WELLBUTRIN SR_ is not indicated for use in children or adolescents aged less than 18 years (see _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The safety and efficacy of _WELLBUTRIN SR_ tablets in patients under 18 years of age have not been established. **Use in elderly** Greater sensitivity of some elderly individuals to bupropion cannot be ruled out, hence a reduced frequency and/or dose may be required (see _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Use in patients with liver impairment** _WELLBUTRIN SR_ should be used with caution in patients with liver impairment. Because of increased variability in the pharmacokinetics in patients with mild to moderate hepatic cirrhosis, a reduced frequency of dosing should be considered (see _Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)_. _WELLBUTRIN SR_ should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 150 mg on alternate days in these patients (see _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Use in patients with renal impairment** Treatment of patients with renal impairment should be initiated at reduced frequency and/or dose, as bupropion and its metabolites may accumulate in such patients to a greater extent than usual (see _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).