VOXRA Extended-release tablet Ref.[115265] Active ingredients: Bupropion

Therapy should be initiated by medical practitioners experienced in the treatment of depression.

Posology

Initial treatment

The initial dose of VOXRA XL is 150 mg taken as a single daily dose in the morning. Patients who are not responding adequately to a dose of 150 mg/day may benefit from an increase to the usual adult target dose of 300 mg/day, given once daily. There should be an interval of at least 24 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 24 hours between doses) or, if clinically indicated, dose reduction.

Switching Patients from sustained release tablets

When switching patients from sustained release tablets to extended-release tablets; give the same total daily dose when possible. Patients who are currently being treated with sustained release tablets at 300 mg/day (e.g.,150 mg twice daily) may be switched to extended-release tablets 300 mg once daily.

Special Populations

Children and Adolescents

VOXRA XL is not indicated for use in children or adolescents aged less than 18 years (see section 4.3).

Elderly

Greater sensitivity of some elderly individuals to VOXRA XL cannot be ruled out, hence a reduced frequency and/or dose may be required (see section 4.4).

Renal Impairment

Treatment of patients with renal impairment should be initiated at a reduced frequency and/or dose, as bupropion and its metabolites may accumulate in such patients to a greater extent than usual (see section 4.4).

Liver Impairment

VOXRA XL should be used with caution in patients with mild liver impairment. Because of increased variability in VOXRA XL's pharmacokinetics in patients with mild hepatic cirrhosis, a reduced frequency of dosing should be considered (see sections 4.8 and 4.4.). VOXRA XL is contra-indicated in patients with moderate to severe hepatic cirrhosis.

Method of administration

VOXRA XL 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.

In addition to those events reported under Side effects, overdose has resulted in symptoms including drowsiness, loss of consciousness and ECG changes such as conduction disturbances (including QRS prolongation) or dysrhythmias - cases of fatal outcome have been reported. Serotonin syndrome has also been reported.

Acute ingestion of doses in excess of 10 times the maximum therapeutic dose has been reported.

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 or as recommended by the national poisons centre, where available.

24 months.

Store at or below 25°C.

Store in the original container in order to protect from humidity and light. Keep well closed.

VOXRA XL 150: White opaque plastic HDPE bottles with white polypropylene plastic child-resistance closures, containing 30 tablets.

VOXRA XL 300: White opaque plastic HDPE bottles with white polypropylene plastic child-resistance closures, containing 30 tablets.

No special requirements for disposal.